(Promulgated by Order No. 6 of the State Food and Drug Administration on February 4, 2004; amended according to November 2017) On the 7th, at the State Food and Drug Administration’s Bureau Meeting, the “Decision on Amending Certain Regulations” was adopted (amended).

　　Chapter One General then

　　Article 1: In order to strengthen the supervision and management of pharmaceutical business licensing, these Measures are formulated in accordance with the relevant provisions of the "Drug Administration Law of the People's Republic of China" and the "Regulations for the Implementation of the Drug Administration Law of the People's Republic of China" (hereinafter referred to as the "Drug Administration Law" and the "Regulations for the Implementation of the Drug Administration Law").

　　Article 2: This Regulation applies to the issuance, renewal, modification, and supervisory management of Pharmaceutical Business Licenses.

　　Article 3: The National Medical Products Administration is responsible for the supervision and management of drug distribution licenses nationwide.

　　The food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government are responsible for issuing, renewing, amending, and conducting routine supervision and management of pharmaceutical wholesale enterprises' Drug Operation Licenses within their respective jurisdictions. They also provide guidance and oversight to lower-level food and drug administration departments in carrying out the supervision and management of Drug Operation Licenses.

　　The municipal-level food and drug administration departments, or the county-level food and drug administration departments directly established by the provincial, autonomous region, or municipality-level food and drug administration departments, are responsible for issuing, renewing, amending, and conducting routine supervision and management of pharmaceutical retail enterprises’ “Pharmaceutical Operation Licenses” within their respective jurisdictions.

　　Chapter 2: Requirements for Applying for a Pharmaceutical Business License

　　Article 4: In accordance with Article 14 of the Drug Administration Law, to establish a wholesale drug enterprise, one must meet the requirements for the rational layout of wholesale drug enterprises set forth by provinces, autonomous regions, and municipalities directly under the central government, and also comply with the following establishment standards:

　　(1) Having regulations and systems in place to ensure the quality of the pharmaceutical products being handled.

　　(2) The enterprise, the legal representative of the enterprise, the person in charge of the enterprise, and the person responsible for quality management shall not fall under any of the circumstances specified in Article 75 or Article 82 of the Drug Administration Law.

　　(3) Possess a certain number of licensed pharmacists commensurate with the scale of operations. The person in charge of quality management must hold a college degree or higher and is required to be a licensed pharmacist.

　　(4) Possess ambient-temperature warehouses, cool-storage warehouses, and cold-storage warehouses that are capable of meeting the quality requirements for pharmaceutical storage and are appropriately sized and configured to match the types and scale of pharmaceutical products handled. The warehouses shall be equipped with dedicated shelving suitable for pharmaceutical storage, as well as modern logistics systems and equipment that enable efficient processes for receiving, conveying, sorting, placing on shelves, and dispatching pharmaceuticals.

　　(5) Possess an independent computer-based management information system capable of covering the entire process of pharmaceutical procurement, storage, sales, operations, and quality control within the enterprise; able to comprehensively record information related to enterprise management and the implementation of the “Good Practice for Pharmaceutical Distribution”; comply with all requirements of the “Good Practice for Pharmaceutical Distribution” for each stage of pharmaceutical distribution, and be equipped with the necessary conditions to enable supervision and regulation by the local food and drug administration authorities.

　　(6) Possess the conditions required by the “Good Supply Practice for Pharmaceutical Products” with regard to pharmaceutical business premises, ancillary and office spaces, warehouse management, quality and safety assurance of pharmaceutical products within warehouses, as well as inbound and outbound procedures, in-warehouse storage, and maintenance.

　　If the State has separate provisions regarding the operation of anesthetic drugs, psychotropic drugs, toxic medicinal products for medical use, and prophylactic biological products, such provisions shall prevail.

　　Article 5: The establishment of retail pharmaceutical enterprises shall comply with requirements related to the local resident population size, geographical location, transportation conditions, and actual needs, adhere to the principle of facilitating public access to medications, and meet the following site-selection regulations:

　　(1) Having regulations and systems in place to ensure the quality of the pharmaceutical products being handled.

　　(2) Pharmacists who have been legally qualified and certified.

　　Pharmaceutical retail enterprises operating prescription drugs and Class A over-the-counter drugs must be staffed with licensed pharmacists or other pharmacy technicians who have been legally qualified. The person responsible for quality management shall have at least one year (inclusive) of experience in pharmaceutical quality management.

　　Pharmaceutical retail enterprises operating Class B over-the-counter drugs, as well as those established in rural and township areas below the county level, shall, in accordance with Article 15 of the Implementation Regulations of the Drug Administration Law, be staffed with qualified personnel. Where conditions permit, they shall also employ licensed pharmacists. During business hours, all of the above-mentioned personnel must be on duty.

　　(3) The enterprise, the legal representative of the enterprise, the person in charge of the enterprise, and the person responsible for quality shall not fall under any of the circumstances specified in Article 75 or Article 82 of the Drug Administration Law.

　　(4) Possess business premises, equipment, storage facilities, and sanitary conditions that are suitable for the pharmaceutical products being sold. If a retail pharmacy is established within other commercial enterprises such as supermarkets, it must have a separate, dedicated area.

　　(5) Possess the capability to stock medications that meet the needs of local consumers and ensure a 24-hour supply. The number of essential national drug varieties that pharmaceutical retail enterprises should stock shall be determined by the food and drug administration departments of each province, autonomous region, and municipality directly under the central government, taking into account local conditions.

　　If the State has separate provisions regarding the operation of anesthetic drugs, psychotropic drugs, toxic medicinal products for medical use, and prophylactic biological products, such provisions shall prevail.

　　Article 6: The acceptance and implementation standards for establishing wholesale pharmaceutical enterprises shall be formulated by the National Medical Products Administration. The acceptance and implementation standards for establishing retail pharmaceutical enterprises shall be organized and formulated by the medical products administration departments of each province, autonomous region, and municipality directly under the central government, based on these Measures and relevant provisions of the “Good Supply Practice for Pharmaceutical Products,” and shall be filed with the National Medical Products Administration.

　　Article 7: Determination of the scope of business for pharmaceutical enterprises.

　　Scope of business for pharmaceutical enterprises:

　　Anesthetic drugs, psychotropic drugs, and toxic drugs for medical use;

　　Biological products;

　　Traditional Chinese medicinal materials, sliced traditional Chinese medicines, proprietary Chinese medicines, chemical raw materials and their preparations, antibiotic raw materials and their preparations, and biochemical drugs.

　　Those engaged in pharmaceutical retailing must first determine the category of their business operations, verify whether the applicant is qualified to sell prescription drugs, over-the-counter (OTC) drugs, or Class II OTC drugs, and clearly specify this qualification in the scope of business activities before determining the specific scope of operations.

　　The approval of toxic drugs for medical use, anesthetic drugs, psychotropic drugs, radioactive drugs, and prophylactic biological products shall be carried out in accordance with the relevant regulations on the management of special pharmaceuticals and prophylactic biological products issued by the state.

　　Chapter 3: Procedures for Applying for a Pharmaceutical Business License

　　Article 8: To establish a pharmaceutical wholesale enterprise, obtain the “Pharmaceutical Business License” according to the following procedures:

　　(1) The applicant shall submit a preparatory establishment application to the food and drug administration department of the province, autonomous region, or municipality where the proposed enterprise is located, and provide the following materials:

　　1. Original and photocopy of the educational certificates of the legal representative, enterprise head, and quality manager of the proposed enterprise, as well as their personal resumes;

　　2. Original and a copy of the practicing pharmacist’s practice certificate;

　　3. Scope of pharmaceutical products to be operated;

　　4. Proposed business premises, equipment, storage facilities, and surrounding sanitary conditions.

　　(2) The food and drug administration department shall handle applications submitted by applicants according to the following circumstances:

　　1. If the application does not fall within the purview of this department’s jurisdiction, a decision of non-acceptance shall be made immediately, and a “Notice of Non-Acceptance” shall be issued, informing the applicant to submit the application to the relevant food and drug administration authority.

　　2. If the application materials contain errors that can be corrected on the spot, applicants should be allowed to correct them immediately on the spot.

　　3. If the application materials are incomplete or do not conform to the legally prescribed format, the applicant shall be issued a “Notice of Supplementary Materials” on the spot or within 5 days, clearly informing them in one go of all the items that need to be supplemented. If the applicant is not notified within the specified time limit, the application shall be deemed to have been accepted as of the date on which the application materials were received.

　　4. If the application falls within the jurisdiction of this department and the submitted materials are complete and conform to the prescribed format, or if the applicant submits all the required supplementary materials as requested, the applicant will be issued a “Notice of Acceptance.” The date indicated on the “Notice of Acceptance” shall be the date of acceptance.

　　(3) Within 30 working days from the date of receipt of the application, the food and drug administration department shall review the submitted materials in accordance with Article 4 of these Measures and make a decision on whether to approve the establishment of the entity. The department shall notify the applicant in writing of its decision. If the application is not approved, the department shall state the reasons for its decision and inform the applicant of their right to file an administrative reconsideration or bring an administrative lawsuit in accordance with the law.

　　(4) After completing the preparatory work, the applicant shall submit a request for acceptance inspection to the food and drug administration department that受理 the application, and provide the following materials:

　　1. Application Form for Pharmaceutical Business License;

　　2. Business license;

　　3. Organizational structure of the proposed enterprise;

　　4. Floor plans of business premises and warehouses, as well as proof of property ownership or usage rights;

　　5. Qualification certificates and appointment letters for pharmacy professionals who have been legally certified;

　　6. Proposed enterprise quality management documents and a catalog of storage facilities and equipment.

　　(5) Within 30 working days from the date of receipt of the acceptance application, the food and drug administration department responsible for handling the application shall organize an acceptance inspection in accordance with the Implementation Standards for the Acceptance of Pharmaceutical Wholesale Enterprises and make a decision on whether to issue a “Pharmaceutical Operation License.” If the applicant meets the requirements, a “Pharmaceutical Operation License” shall be issued. If the applicant does not meet the requirements, the applicant shall be notified in writing, with a detailed explanation of the reasons, and informed at the same time that they have the right, under the law, to apply for administrative reconsideration or file an administrative lawsuit.

　　Article 9: To establish a retail pharmaceutical enterprise, obtain a Pharmaceutical Business License according to the following procedures:

　　(1) The applicant shall submit a preparatory establishment application directly to the municipal-level food and drug administration department where the proposed enterprise is located, or to the county-level food and drug administration department directly established by the provincial, autonomous region, or municipality-level food and drug administration department, and shall provide the following materials:

　　1. Original and photocopies of the educational qualifications, practice certificates or professional titles of the legal representative, enterprise head, and quality manager of the proposed enterprise, as well as personal resumes, qualification certificates for specialized technical personnel, and appointment letters.

　　2. Scope of pharmaceutical products to be operated;

　　3. Proposed business premises, warehousing facilities, and equipment details.

　　(2) The food and drug administration department shall handle applications submitted by applicants according to the following circumstances:

　　1. If the application does not fall within the purview of this department’s jurisdiction, a decision of non-acceptance shall be made immediately, and a “Notice of Non-Acceptance” shall be issued, informing the applicant to submit the application to the relevant food and drug administration authority.

　　2. If the application materials contain errors that can be corrected on the spot, applicants should be allowed to correct them immediately on the spot.

　　3. If the application materials are incomplete or do not conform to the legally prescribed format, the applicant shall be issued a “Notice of Supplementary Materials” on the spot or within 5 days, clearly informing them in one go of all the items that need to be supplemented. If the applicant is not notified within the specified time limit, the application shall be deemed to have been accepted as of the date on which the application materials were received.

　　4. If the application falls within the jurisdiction of this department and the submitted materials are complete and conform to the prescribed format, or if the applicant submits all the required supplementary materials as requested, the applicant will be issued a “Notice of Acceptance.” The date indicated on the “Notice of Acceptance” shall be the date of acceptance.

　　(3) Within 30 working days from the date of receipt of the application, the food and drug administration department shall review the submitted materials in accordance with Article 5 of these Measures and make a decision on whether to approve the establishment of the facility. The department shall notify the applicant in writing of its decision. If the application is not approved, the department shall state the reasons for its decision and inform the applicant of their legal rights to request administrative reconsideration or file an administrative lawsuit.

　　(4) After completing the preparatory work, the applicant shall submit a request for acceptance inspection to the food and drug administration department that受理 the application, and provide the following materials:

　　1. Application Form for Pharmaceutical Business License;

　　2. Business license;

　　3. Floor plans of business premises and warehouses, as well as proof of property ownership or usage rights;

　　4. Qualification certificates and appointment letters for pharmacy professionals who have been legally certified;

　　5. Draft documents for enterprise quality management, along with a catalog of major facilities and equipment.

　　(5) Within 15 working days from the date of receipt of the acceptance application, the food and drug administration department responsible for handling the application shall organize an inspection in accordance with the Implementation Standards for the Acceptance of Applications to Establish Retail Drug Enterprises and make a decision on whether to issue a “Drug Operation License.” If the application does not meet the requirements, the department shall notify the applicant in writing, stating the reasons for the rejection. At the same time, the department shall inform the applicant of their right, under the law, to file an administrative reconsideration or bring an administrative lawsuit.

　　Article 10: When the food and drug administration department reviews an applicant’s application, if it finds that the administrative licensing matter directly affects the significant interests of others, it shall notify the interested parties. The receiving authority shall listen to the statements and defenses made by both the applicant and the interested parties. Where a hearing is required by law, a hearing shall be held in accordance with the provisions of the law.

　　Article 11: The food and drug administration department shall make public the relevant information about the “Pharmaceutical Business Licenses” that have already been issued, and the public has the right to access such information.

　　If it is discovered after the information has been made public that an enterprise has provided false documents, data, or engaged in other deceptive practices during the application process for a Pharmaceutical Business License, it shall be dealt with according to law.

　　Article 12: The “Pharmaceutical Business License” is the legal credential for enterprises engaged in pharmaceutical business activities. No organization or individual may forge, alter, buy, sell, lease, or lend it.

　　Chapter Four: Amendment and Reissuance of the Pharmaceutical Business License

　　Article 13: Amendments to the Pharmaceutical Business License are categorized into amendments to licensed matters and amendments to registered matters.

　　A change in licensed matters refers to changes in the business model, scope of business, registered address, warehouse addresses (including additions or reductions of warehouses), the legal representative or person in charge of the enterprise, and the person responsible for quality.

　　A change in registration items refers to changes in any matters other than those listed above.

　　Article 14: If a pharmaceutical distribution enterprise wishes to amend any licensed items on its Pharmaceutical Distribution License, it shall apply to the original issuing authority for amendment registration of the Pharmaceutical Distribution License no later than 30 days prior to the date of the change in the original licensed item. No changes to the licensed items may be made without prior approval.

　　The original issuing authority shall, within 15 working days from the date of receipt of the enterprise’s application for amendment and the supporting documentation for the amendment, make a decision to approve or disapprove the amendment.

　　For applications to amend licensed matters, the original issuing authority shall conduct an acceptance inspection in accordance with the conditions stipulated in these Measures before processing the amendment procedures.

　　After a pharmaceutical enterprise legally changes the licensed items on its Pharmaceutical Business License, it shall, in accordance with the law, complete the relevant amendment procedures for enterprise registration and filing with the administration for industry and commerce.

　　In the event of a company’s spin-off, merger, change in business operations, or relocation across its original jurisdiction, the “Pharmaceutical Business License” shall be reissued in accordance with the provisions of these Measures.

　　Article 15: If a non-legal entity branch of a corporate legal person applies to change the licensed items on its Pharmaceutical Operation License, it must submit a change application signed with the opinion of its superior legal person.

　　Article 16: If an enterprise has been investigated by the food and drug administration department for illegal business activities but the case has not yet been concluded, or if an administrative penalty decision has already been made but the penalty has not yet been executed, the licensing authority shall suspend the acceptance of applications for amendments to its Pharmaceutical Business License.

　　Article 17: If a pharmaceutical enterprise changes any registered items on its Pharmaceutical Business License, it shall, within 30 days after the change has been approved by the administration for industry and commerce, apply to the original issuing authority for an amendment registration of the Pharmaceutical Business License. The original issuing authority shall complete the amendment procedures for the enterprise within 15 working days from the date of receipt of the enterprise’s amendment application and supporting documentation.

　　Article 18: After the registration details of the Pharmaceutical Business License have been changed, the original issuing authority shall record the content and date of the change on the duplicate copy of the Pharmaceutical Business License, reissue the original copy of the Pharmaceutical Business License according to the revised details, and retrieve the original copy of the Pharmaceutical Business License. The validity period of the amended Pharmaceutical Business License remains unchanged.

　　Article 19: The validity period of the "Pharmaceutical Business License" is five years. If a licensed enterprise wishes to continue operating pharmaceutical products upon expiration of the license, it shall apply to the original licensing authority for a renewal of the "Pharmaceutical Business License" within six months prior to the expiration date. The original licensing authority shall review the application in accordance with the eligibility criteria stipulated in these Measures. If the applicant meets the requirements, the original license will be revoked and a new license will be issued. If the applicant does not meet the requirements, it may be given a three-month deadline to make corrections. If the applicant still fails to meet the requirements after making the necessary corrections, the original "Pharmaceutical Business License" will be revoked.

　　The food and drug administration shall, upon application by a pharmaceutical distribution enterprise, make a decision on whether to approve the renewal of its Pharmaceutical Distribution License before the expiration date of the license. If no decision is made within the prescribed time limit, it shall be deemed that the renewal has been approved.

　　Chapter 5: Supervision and Inspection

　　Article 20: The food and drug administration department shall strengthen supervision and inspection of enterprises holding Drug Operation Licenses. Enterprises holding such licenses shall accept supervision and inspection in accordance with the provisions of these Measures.

　　Article 21: The main contents of supervision and inspection include:

　　(1) The implementation and changes regarding key matters such as the enterprise name, business address, warehouse address, legal representative (enterprise head), quality manager, mode of operation, scope of business, and branch offices;

　　(2) Changes in the enterprise’s operational facilities, equipment, and warehousing conditions;

　　(3) The enterprise’s implementation of the “Good Supply Practice for Pharmaceutical Products”;

　　(4) Other relevant matters that the issuing authority needs to review.

　　Article 22: Supervisory inspections may be conducted through written reviews, on-site inspections, or a combination of both written and on-site inspections.

　　(1) The licensing authority may require licensed enterprises to submit materials related to their Pharmaceutical Business License and, by reviewing these materials, fulfill its supervisory duties.

　　(2) The licensing authority may conduct on-site inspections of licensed enterprises.

　　Enterprises falling under any of the following circumstances must undergo on-site inspections:

　　1. Enterprises newly established in the previous year;

　　2. Enterprises identified as having issues during the previous year’s inspection;

　　3. Enterprises that have been subject to administrative penalties for violating relevant laws and regulations;

　　4. Enterprises that the issuing authority deems require an on-site inspection.

　　In the year when the renewal of the “Pharmaceutical Business License” is carried out, supervisory inspections and license renewal reviews can be conducted simultaneously.

　　Article 23: The on-site inspection standards for the "Pharmaceutical Operation License" shall be formulated by the licensing authority in accordance with the acceptance and implementation standards for establishing wholesale pharmaceutical enterprises, the acceptance and implementation standards for establishing retail pharmaceutical enterprises, the certification inspection standards of the "Good Supply Practice for Pharmaceutical Products," and the corresponding on-site inspection items, and shall be filed with the next higher-level food and drug administration department.

　　Article 24: For business entities found during supervision and inspection to be in violation of the requirements of the "Good Supply Practice for Pharmaceutical Products," the licensing authority shall order them to make rectifications within a specified time limit. If, after rectification, an entity continues to engage in pharmaceutical business activities in violation of Article 16 of the "Pharmaceutical Administration Law," it shall be dealt with in accordance with Article 78 of the "Pharmaceutical Administration Law."

　　Article 25: When the licensing authority conducts supervision and inspection of pharmaceutical enterprises in accordance with the law, it shall record the details of the inspection and the outcomes of any actions taken. After being signed by the inspectors, these records shall be filed. The public has the right to review the relevant inspection records. The results of on-site inspections shall be recorded on the duplicate copy of the Pharmaceutical Business License and publicly announced by the licensing authority.

　　Article 26: The “Pharmaceutical Business License” shall be revoked by the original issuing authority if any of the following circumstances apply:

　　(1) Those whose “Pharmaceutical Business License” has expired and has not been renewed;

　　(2) A pharmaceutical enterprise that ceases operations or closes down;

　　(3) The Pharmaceutical Business License has been revoked, withdrawn, suspended, recalled, surrendered, or declared invalid in accordance with the law;

　　(4) The licensed items of the Pharmaceutical Business License cannot be implemented due to force majeure;

　　(5) Other circumstances stipulated by laws and regulations that require the cancellation of an administrative license.

　　If the food and drug administration department revokes a “Pharmaceutical Business License,” it shall notify the relevant administration for industry and commerce within 5 working days from the date of revocation.

　　Article 27: The Pharmaceutical Business License consists of an original and a duplicate. The original and the duplicate have equal legal effect.

　　Article 28: The licensing authority shall establish work files covering the issuance, renewal, supervision and inspection, and amendments of Pharmaceutical Operation Licenses. Each quarter, in the first ten days of the quarter, the authority shall report to the next higher-level food and drug administration department on the issuance and amendment status of Pharmaceutical Operation Licenses. For Pharmaceutical Operation Licenses that have been revoked, invalidated, or otherwise withdrawn due to reasons such as amendments, renewals, suspension, or surrender, the relevant files shall be retained for a period of five years.

　　Article 29: If a business loses its Pharmaceutical Business License, it shall immediately report the loss to the licensing authority and publish a notice of loss in a media outlet designated by the licensing authority. One month after the date on which the business publishes the notice of loss, the licensing authority shall reissue the Pharmaceutical Business License in accordance with the originally approved details.

　　Article 30: If a business ceases operating pharmaceutical products or closes down, its Pharmaceutical Business License shall be revoked by the original issuing authority.

　　If the licensing authority revokes, cancels, or collects a Pharmaceutical Business License, it shall promptly notify the administration for industry and commerce and publicly announce such action to the public.

　　Article 31: The original copy of the Pharmaceutical Business License shall be displayed in a prominent location at the business premises of the enterprise.

　　Chapter Six: Appendices then

　　Article 32: The "Pharmaceutical Business License" shall specify the following items: enterprise name, name of the legal representative or person in charge of the enterprise, mode of operation, scope of business, registered address, warehouse address, license number, serial number, issuing authority, date of issuance, and validity period.

　　The formats and numbering methods for the original and duplicate copies of the Pharmaceutical Business License shall be uniformly formulated by the National Medical Products Administration.

　　Article 33: The “Pharmaceutical Business License” shall be uniformly printed by the National Medical Products Administration.

　　Article 34: The electronic certificate for pharmaceutical business licenses issued by the food and drug administration department has the same legal effect as the printed pharmaceutical business license certificate.

　　Article 35: These Measures shall take effect as of April 1, 2004.

　　Administrative Measures for Internet Pharmaceutical Information Services

　　(Promulgated by Order No. 9 of the State Food and Drug Administration on July 8, 2004; amended according to November 2017)

　　On the 7th, at the State Food and Drug Administration’s Bureau Meeting, the “Decision on Amending Certain Regulations” was adopted (amended).

　　Article 1: In order to strengthen the supervision and administration of pharmaceuticals, standardize internet-based pharmaceutical information services, and ensure the authenticity and accuracy of pharmaceutical information available on the internet, these Measures are formulated in accordance with the "Pharmaceutical Administration Law of the People's Republic of China" and the "Administrative Measures for Internet Information Services."

　　Article 2: This Regulation applies to activities providing internet-based pharmaceutical information services within the territory of the People’s Republic of China.

　　The internet pharmaceutical information services referred to in these Measures refer to service activities that provide pharmaceutical (including medical device) information to internet users via the internet.

　　Article 3: Internet-based pharmaceutical information services are categorized into two types: commercial and non-commercial.

　　Commercial internet pharmaceutical information services refer to activities that provide pharmaceutical information and other related services to internet users for a fee via the internet.

　　Non-commercial internet pharmaceutical information services refer to activities that provide, free of charge and on a publicly accessible, shared basis, pharmaceutical information and other related services to internet users via the internet.

　　Article 4: The National Medical Products Administration shall exercise supervision and management over websites nationwide that provide internet-based pharmaceutical information services.

　　The food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall exercise supervision and management over websites providing internet-based pharmaceutical information services within their respective administrative jurisdictions.

　　Article 5: Websites intending to provide Internet-based pharmaceutical information services shall, prior to applying for an operating license or filing registration with the competent authority for the information industry under the State Council or the provincial telecommunications regulatory agency, submit an application to the food and drug administration department of the province, autonomous region, or municipality directly under the central government where the website’s organizer is located, in accordance with the principle of local supervision and administration. After passing the review and obtaining approval, such websites may qualify to provide Internet-based pharmaceutical information services.

　　Article 6: The food and drug administration departments of each province, autonomous region, and municipality directly under the central government shall review websites applying for internet-based pharmaceutical information services within their respective jurisdictions. Those that meet the requirements shall be issued an “Internet Pharmaceutical Information Service Qualification Certificate.”

　　Article 7: The format of the “Internet Pharmaceutical Information Service Qualification Certificate” shall be uniformly prescribed by the National Medical Products Administration.

　　Article 8: Websites providing internet-based pharmaceutical information services shall prominently display the certificate number of the “Internet Pharmaceutical Information Service Qualification Certificate” in a conspicuous location on their website’s homepage.

　　Article 9: The pharmaceutical information posted on websites providing internet-based pharmaceutical information services must be scientific and accurate, and must comply with the country’s laws, regulations, and relevant provisions governing the management of pharmaceuticals and medical devices.

　　Websites providing internet-based pharmaceutical information services shall not publish product information on anesthetic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, drug addiction treatment drugs, or preparations formulated by medical institutions.

　　Article 10: Advertisements for pharmaceutical products (including medical devices) published on websites providing internet-based pharmaceutical information services must be reviewed and approved by the food and drug administration department.

　　Advertisements for pharmaceutical products (including medical devices) published on websites providing internet-based pharmaceutical information services must indicate the approval number for advertising review.

　　Article 11: To apply for the provision of internet-based pharmaceutical information services, in addition to meeting the requirements stipulated in the “Administrative Measures for Internet Information Services,” applicants must also satisfy the following conditions:

　　(1) Providers of internet-based pharmaceutical information services shall be legally established enterprises, institutions, or other organizations.

　　(2) Possessing professional personnel, facilities, and relevant systems that are suitable for conducting internet-based pharmaceutical information services;

　　(3) There shall be two or more personnel who are familiar with the laws and regulations governing pharmaceuticals and medical devices, as well as possess specialized knowledge in pharmaceuticals and medical devices, or who have been legally qualified as pharmacy or medical device technicians.

　　Article 12: An application for providing internet-based pharmaceutical information services shall be based on a single website as the fundamental unit.

　　Article 13: To apply for the provision of Internet-based pharmaceutical information services, applicants shall complete the “Application Form for Internet-Based Pharmaceutical Information Services,” uniformly issued by the National Medical Products Administration, and submit the application to the medical products administration department of the province, autonomous region, or municipality directly under the central government where the website’s host organization is located. At the same time, the following materials must be submitted:

　　(1) A copy of the business license.

　　(2) Relevant certificates or supporting documents for website domain name registration. The Chinese names of websites providing internet-based pharmaceutical information services, except those identical to the name of the sponsoring entity, shall not include terms such as “China,” “Chinese,” or “National.” Except for websites operated by entities holding qualifications as pharmaceutical bidding agents, other websites providing internet-based pharmaceutical information services shall not include terms such as “e-commerce,” “pharmaceutical investment promotion,” or “pharmaceutical bidding” in their names.

　　(3) Instructions on Website Section Setup (Websites applying for commercial online pharmaceutical information services must provide details on fee-based sections and the corresponding charging methods).

　　(4) Description of the management system and implementation status regarding the backup and retrieval of previously published information on the website.

　　(5) Methods and operational instructions for the food and drug administration department to browse all sections and content on the website online.

　　(6) Photocopy of educational credentials or professional qualification certificates of technical personnel specializing in pharmaceuticals and medical devices, photocopy of the website administrator’s ID card, and resume.

　　(7) Sound network and information security safeguards, including website security measures, information security confidentiality management systems, and user information security management systems.

　　(8) Management measures, explanatory statements, and relevant supporting documents ensuring that the sources of drug information are legal, authentic, and secure.

　　Article 14: Within 5 days from the date of receipt of the application materials, the food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall decide whether to accept the application. If accepted, they shall issue a notice of acceptance; if not accepted, they shall notify the applicant in writing, stating the reasons for non-acceptance and informing the applicant of their right to file an administrative reconsideration or bring an administrative lawsuit in accordance with the law.

　　Article 15: If the application materials are not standardized or are incomplete, the food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall, within 5 days from the date of application, notify the applicant once of all the items that need to be corrected. If such notification is not provided within the specified period, the application shall be deemed to have been accepted as of the date on which the materials were received.

　　Article 16: Within 20 days from the date of acceptance, the food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall review the materials submitted by applicants for internet-based pharmaceutical information services and make a decision to approve or disapprove the application. If approved, the food and drug administration department of the province, autonomous region, or municipality directly under the central government shall issue an “Internet Pharmaceutical Information Service Qualification Certificate,” simultaneously filing the approval with the National Medical Products Administration and publishing a public announcement. If disapproved, the applicant shall be notified in writing, with reasons provided, and informed of their right to file an administrative reconsideration or bring an administrative lawsuit in accordance with the law.

　　The National Medical Products Administration supervises the review work conducted by the food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government.

　　Article 17: The validity period of the “Internet Pharmaceutical Information Service Qualification Certificate” is five years. If a certificate holder wishes to continue providing internet pharmaceutical information services upon expiration of the validity period, it shall apply to the original issuing authority for the reissuance of the “Internet Pharmaceutical Information Service Qualification Certificate” within six months prior to the expiration date. After reviewing the application, the original issuing authority shall reissue a new certificate if it finds that the applicant meets the required conditions; if the applicant does not meet the requirements, the authority shall issue a notice of non-reissuance, stating the reasons therefor. The original “Internet Pharmaceutical Information Service Qualification Certificate” will be withdrawn by the original issuing authority and publicly announced as canceled.

　　The food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall, based on the applicant’s application, make a decision on whether to grant a renewal of the “Internet Drug Information Service Qualification Certificate” before the expiration date of the certificate. If no decision is made within the prescribed time limit, it shall be deemed that the renewal has been approved.

　　Article 18: The “Internet Pharmaceutical Information Service Qualification Certificate” may, upon written application by the provider of internet pharmaceutical information services, be revoked by the original issuing authority. The original issuing authority shall file a record with and publish an announcement through the National Medical Products Administration. Websites whose “Internet Pharmaceutical Information Service Qualification Certificates” have been revoked shall not continue to engage in internet pharmaceutical information services.

　　Article 19: If an internet-based pharmaceutical information service provider changes any of the following items, it shall apply to the original issuing authority for amendment procedures, complete the “Application Form for Amendment of Internet-Based Pharmaceutical Information Service Projects,” and simultaneously provide the following relevant supporting documents:

　　(1) The items approved in the “Internet Pharmaceutical Information Service Qualification Certificate” (including the name of the internet pharmaceutical information service provider, website name, IP address, etc.);

　　(2) Basic information of internet-based pharmaceutical information service providers (such as address, legal representative, and enterprise head);

　　(3) The basic information about the internet pharmaceutical information services provided by the website (including service methods and service items, etc.).

　　Article 20: Within 20 working days from the date of acceptance of the application for amendment, the food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall make a review decision on whether to approve the amendment. If the amendment is approved, the results of the amendment shall be publicly announced and reported to the National Medical Products Administration for record; if the amendment is not approved, the applicant shall be notified in writing, with a detailed explanation of the reasons.

　　Article 21: When reviewing applications submitted by applicants, the food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall publicly disclose the approval process and the approval results. Applicants and stakeholders may submit written statements and defenses on matters that directly affect their significant interests. Where a hearing is required by law, a hearing shall be held in accordance with the prescribed legal procedures.

　　Article 22: Any entity that engages in internet-based pharmaceutical information services without obtaining or beyond the validity period of the "Internet Pharmaceutical Information Service Qualification Certificate" shall receive a warning and be ordered to cease such activities by the State Administration for Market Regulation of Food and Drugs or the food and drug administration authorities of provinces, autonomous regions, or municipalities directly under the central government. In cases of serious violations, the matter shall be referred to the relevant authorities for punishment in accordance with applicable laws and regulations.

　　Article 23: Websites providing Internet-based pharmaceutical information services that fail to prominently display the certificate number of the “Internet Pharmaceutical Information Service Qualification Certificate” on the homepage of their website shall receive a warning and be ordered to make corrections within a specified time limit by the State Administration for Food and Drug Supervision or the food and drug supervision authorities of provinces, autonomous regions, and municipalities directly under the central government. If the website fails to make the required corrections within the prescribed time limit, it shall be subject to a fine of less than 500 yuan for websites providing non-commercial Internet-based pharmaceutical information services, and a fine of between 5,000 yuan and 10,000 yuan for websites providing commercial Internet-based pharmaceutical information services.

　　Article 24: If an internet-based pharmaceutical information service provider violates these Measures and falls under any of the following circumstances, it shall receive a warning and be ordered to make corrections within a specified time limit by the State Administration for Food and Drug Administration or the food and drug administration authorities of provinces, autonomous regions, or municipalities directly under the central government. In cases of serious violations, websites providing non-commercial internet-based pharmaceutical information services shall be fined less than 1,000 yuan, while websites providing commercial internet-based pharmaceutical information services shall be fined between 10,000 yuan and 30,000 yuan. If the violation constitutes a crime, the case shall be referred to the judicial authorities for criminal prosecution.

　　(1) Those who have already obtained the “Internet Pharmaceutical Information Service Qualification Certificate” but provide pharmaceutical information that directly facilitates online pharmaceutical transactions;

　　(2) Those who have already obtained the “Internet Pharmaceutical Information Service Qualification Certificate” but provide internet pharmaceutical information services beyond the scope approved during the review;

　　(3) Providing false internet-based pharmaceutical information services that have caused adverse social impacts;

　　(4) Unauthorized alteration of the internet-based pharmaceutical information service project.

　　Article 25: If an internet-based pharmaceutical information service provider unlawfully uses the “Internet Pharmaceutical Information Service Qualification Certificate” in its business activities, it shall be penalized by the National Medical Products Administration or the medical products administration department of the province, autonomous region, or municipality directly under the central government, in accordance with relevant laws and regulations.

　　Article 26: If the food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government unlawfully issue approval for applications for internet-based pharmaceutical information services, the original issuing authority shall revoke the originally approved "Internet Pharmaceutical Information Service Qualification Certificate." If this results in damage to the legitimate rights and interests of the applicant, the original issuing authority shall provide compensation in accordance with the provisions of the State Compensation Law. In addition, the directly responsible principal personnel and other persons directly liable shall be subject to administrative disciplinary action by their respective units or higher authorities in accordance with the law.

　　Article 27: The food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall conduct supervision and inspection of websites providing internet-based pharmaceutical information services and shall publicly announce the results of such inspections.

　　Article 28: The National Medical Products Administration is responsible for interpreting these Measures.

　　Article 29: These Measures shall take effect as of the date of their promulgation. The “Interim Provisions for the Administration of Internet Pharmaceutical Information Services” (Order No. 26 of the National Medical Products Administration) shall be repealed concurrently.

　　Measures for the Supervision and Administration of Pharmaceutical Production

　　(Announced by Order No. 14 of the State Food and Drug Administration on August 5, 2004; amended according to November 2017) On the 7th, at the State Administration for Market Regulation’s Bureau Meeting, the “Decision on Amending Certain Regulations” was adopted (amended).

　　Chapter One General then

　　Article 1: In order to strengthen the supervision and management of pharmaceutical production, these Measures are formulated in accordance with the "Drug Administration Law of the People's Republic of China" and the "Implementation Regulations of the Drug Administration Law of the People's Republic of China" (hereinafter referred to as the "Drug Administration Law" and the "Implementation Regulations of the Drug Administration Law").

　　Article 2: Drug production supervision and administration refers to the management activities undertaken by the food and drug administration authorities, in accordance with the law, to review, license, and supervise and inspect drug production conditions and processes.

　　Article 3: The National Medical Products Administration is responsible for the supervision and management of pharmaceutical production nationwide; the medical products administration departments of provinces, autonomous regions, and municipalities directly under the central government are responsible for the supervision and management of pharmaceutical production within their respective administrative regions.

　　Chapter 2: Application and Approval for Establishing Pharmaceutical Manufacturing Enterprises

　　Article 4: To establish a pharmaceutical manufacturing enterprise, in addition to complying with the national development plan and industrial policies for the pharmaceutical industry, the enterprise must also meet the following conditions:

　　(1) The enterprise shall have qualified pharmaceutical technicians, engineering technicians, and corresponding technical workers who have been legally certified; the legal representative or person in charge of the enterprise, as well as the quality officer, shall not fall under any of the circumstances specified in Article 75 of the Drug Administration Law.

　　(2) Possessing premises, facilities, and sanitary conditions that are suitable for pharmaceutical production;

　　(3) Possessing institutions, personnel, and the necessary instruments and equipment capable of conducting quality management and quality inspection of the pharmaceutical products being manufactured;

　　(4) Regulations and systems that ensure the quality of pharmaceutical products.

　　If other provisions are stipulated by relevant national laws and regulations regarding the production of narcotic drugs, psychotropic drugs, toxic pharmaceuticals for medical use, radioactive drugs, and drug-related precursors that are easily used for manufacturing drugs, such provisions shall prevail.

　　Article 5: Applicants seeking to establish a pharmaceutical manufacturing enterprise shall submit an application to the food and drug administration department of the province, autonomous region, or municipality where the proposed enterprise is located, and shall provide the following materials:

　　(1) The applicant’s basic information and relevant supporting documents.

　　(2) Basic information about the proposed enterprise, including the proposed enterprise’s name, product categories, dosage forms, equipment, processes, and production capacity; a description of the proposed enterprise’s site, surrounding environment, infrastructure, and other relevant conditions; as well as details on the scale of investment.

　　(3) Business license, production address and registered address, enterprise type, legal representative or person in charge of the enterprise.

　　(4) Organizational chart of the proposed enterprise (clearly indicating the responsibilities and interrelationships of each department, as well as the heads of each department).

　　(5) Resumes of the legal representative, enterprise head, and department heads of the proposed enterprise, along with their educational certificates and professional title certificates; registration forms for pharmaceutical and related professionals, engineering technicians, and skilled workers who have been legally qualified, indicating their respective departments and positions; and a table showing the proportion of senior, intermediate, and junior technical personnel.

　　(6) Site plan of the proposed enterprise, general layout plan, warehouse layout plan, and quality inspection area layout plan.

　　(7) Proposed production process layout plan for the enterprise (including changing rooms, washrooms, pedestrian and material flow channels, airlocks, etc., with clear indications of personnel and material flow directions and air cleanliness levels); plan drawings showing the supply, return, and exhaust air layouts of the air purification system; and process equipment layout plan.

　　(8) The intended scope of production, dosage forms, varieties, quality standards, and the basis for these standards.

　　(9) Prepare process flow diagrams for the proposed dosage forms and varieties, and clearly indicate the key quality control points and parameters.

　　(10) Overview of validation for air purification systems, water production systems, and key equipment; calibration status of production and inspection instruments, meters, and weighing devices.

　　(11) List of Major Production Equipment and Inspection Instruments.

　　(12) List of documents for production management and quality management of the proposed enterprise.

　　The applicant shall be responsible for the authenticity of all contents of the application materials.

　　Article 6: If a pharmaceutical manufacturer splits off part of its production workshop to establish an independent pharmaceutical manufacturing enterprise, it shall obtain a Pharmaceutical Production License in accordance with the provisions of Article 4 and Article 5 of these Measures.

　　Article 7: After receiving an application, the food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall handle it accordingly based on the following circumstances:

　　(1) If the application does not fall within the purview of this department’s authority according to law, a decision rejecting the application shall be made immediately, and the applicant shall be informed to submit the application to the relevant administrative authority.

　　(2) If the application materials contain errors that can be corrected on the spot, the applicant should be allowed to correct them on the spot.

　　(3) If the application materials are incomplete or do not meet the requirements of the formal review, the applicant shall be issued a “Notice of Supplementary Materials” on the spot or within 5 working days, informing the applicant in one go of all the items that need to be supplemented. If the applicant is not notified within the specified period, the application shall be deemed to have been accepted as of the date on which the application materials were received.

　　(4) If the application materials are complete and meet the requirements of the formal review, or if the applicant submits all supplementary materials as required, the application shall be accepted.

　　The food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall issue a “Notice of Acceptance” or a “Notice of Non-Acceptance,” stamped with the department’s official seal for acceptance and dated, when they accept or reject an application for establishing a pharmaceutical manufacturing enterprise.

　　Article 8: The food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall make a decision within 30 working days from the date of receipt of the application.

　　If the application meets the prescribed requirements after review, it shall be approved, and the Pharmaceutical Production License shall be issued within 10 working days from the date of the written approval decision. If the application does not meet the prescribed requirements, a written decision of non-approval shall be made, stating the reasons therefor, and the applicant shall be informed of their right to file an administrative reconsideration or bring an administrative lawsuit in accordance with the law.

　　Article 9: Newly established pharmaceutical manufacturing enterprises, pharmaceutical manufacturing enterprises constructing new pharmaceutical production workshops, or enterprises adding new dosage forms to their production lines shall, within 30 days from the date of obtaining the pharmaceutical production certification document or receiving formal approval to commence production, apply to the relevant food and drug administration department for certification under the “Good Manufacturing Practice for Pharmaceuticals” in accordance with the regulations of the National Medical Products Administration.

　　Article 10: The food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall publicly display on their administrative agencies’ websites and in their office premises the requirements, procedures, time limits, a list of all materials to be submitted, and sample application forms necessary for applying for a Drug Production License.

　　Information regarding the issuance of “Drug Production Licenses” by the food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall be made public, and the public has the right to access such information.

　　Article 11: When reviewing applications for the establishment of pharmaceutical manufacturing enterprises, the food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall publicly disclose the approval process and the approval results. Applicants and interested parties may submit written statements and defenses on matters that directly affect their significant interests.

　　Article 12: If an application to establish a pharmaceutical manufacturing enterprise directly involves significant interests between the applicant and other parties, the food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall inform the applicant and interested parties that they may, in accordance with laws, regulations, and other provisions of the National Medical Products Administration, exercise their right to request a hearing. When reviewing applications to establish pharmaceutical manufacturing enterprises, if the food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government deem that a major licensing matter involves public interest, they shall publicly announce such matter and hold a hearing.

　　Chapter 3: Management of Pharmaceutical Production Licenses

　　Article 13: The Pharmaceutical Production License consists of an original and a duplicate. The original and the duplicate have equal legal effect and are valid for a period of 5 years.

　　The “Drug Production License” is uniformly printed by the National Medical Products Administration.

　　Article 14: The Pharmaceutical Production License shall specify the following items: license number, enterprise name, legal representative, person in charge of the enterprise, enterprise type, registered address, production address, scope of production, issuing authority, date of issuance, and validity period. Among these, the licensing matters approved by the food and drug administration department include: the person in charge of the enterprise, the scope of production, and the production address.

　　The enterprise name, legal representative, registered address, enterprise type, and other such items shall be consistent with the relevant information stated in the business license issued by the administration for industry and commerce.

　　The enterprise name shall comply with the principles of categorized management for pharmaceutical manufacturing enterprises. The production address shall be filled in according to the actual production address of the drug. The license number and scope of production shall be filled in according to the methods and categories specified by the National Medical Products Administration.

　　Article 15: Amendments to the Pharmaceutical Production License are categorized into amendments to licensed items and amendments to registered items.

　　A change in licensed matters refers to changes in the enterprise’s person in charge, scope of production, and production address.

　　A change in registration details refers to a change in the matters listed in Article 14, paragraph 2 of these Measures.

　　Article 16: If a pharmaceutical manufacturer intends to change any licensed item on its Pharmaceutical Production License, it shall submit an application for amendment of the Pharmaceutical Production License to the original issuing authority 30 days prior to the date of the change. No changes to the licensed items may be made without prior approval.

　　The original issuing authority shall, within 15 working days from the date of receipt of the enterprise’s application for amendment, make a decision on whether to approve the amendment. If the amendment is not approved, the authority shall provide a written explanation of the reasons and inform the applicant of their right to file an administrative reconsideration or bring an administrative lawsuit in accordance with the law.

　　If a pharmaceutical manufacturer intends to change its production scope or production address, it shall submit the relevant materials pertaining to the changes in accordance with Article 5 of these Measures and obtain approval following review and decision by the food and drug administration department of the province, autonomous region, or municipality directly under the central government where it is located.

　　After a pharmaceutical manufacturer has legally completed the procedures for amending the items authorized under its Pharmaceutical Production License, it shall promptly apply to the administration for industry and commerce for the corresponding changes to its enterprise registration.

　　Article 17: If a pharmaceutical manufacturer changes any item registered on its Pharmaceutical Production License, it shall, within 30 days after the change has been approved by the administration for industry and commerce, apply to the original licensing authority for amendment registration of the Pharmaceutical Production License. The original licensing authority shall complete the amendment procedures within 15 working days from the date of receipt of the enterprise’s amendment application.

　　Article 18: After a change is made to the "Drug Production License," the original issuing authority shall record the content and date of the change on the duplicate copy of the "Drug Production License." The authority shall then reissue the original "Drug Production License" in accordance with the revised content, retrieve the original "Drug Production License" original, and the validity period of the amended "Drug Production License" shall remain unchanged.

　　Article 19: If a pharmaceutical manufacturer wishes to continue producing drugs after the expiration of its Pharmaceutical Production License, it shall apply to the original issuing authority for the renewal of the Pharmaceutical Production License six months prior to the expiration date.

　　The original issuing authority, taking into account the enterprise’s compliance with laws and regulations, the “Good Manufacturing Practice for Pharmaceuticals,” and the operation of its quality system, shall conduct a review in accordance with the procedures and requirements set forth in these Measures for the establishment of pharmaceutical manufacturing enterprises, and shall make a decision on whether to grant a renewal of the Pharmaceutical Production License before the expiration date of the current license. If the enterprise meets the prescribed requirements, the original license shall be revoked and a new license issued; if it does not meet the requirements, a written decision denying the renewal shall be made, stating the reasons therefor, and the applicant shall be informed of their right to file an administrative reconsideration or bring an administrative lawsuit in accordance with the law. If no decision is made within the prescribed time limit, the renewal shall be deemed approved, and the relevant procedures shall be completed retroactively.

　　Article 20: If a pharmaceutical manufacturer ceases production of pharmaceuticals or closes down, the original licensing authority shall revoke the Pharmaceutical Production License and notify the administration for industry and commerce.

　　Article 21: In the event that a Pharmaceutical Production License is lost, the pharmaceutical manufacturer shall immediately apply to the original issuing authority for a replacement and publish a notice of loss in a media outlet designated by the original issuing authority. One month after the date on which the enterprise publishes the notice of loss, the original issuing authority shall, within 10 working days, reissue the Pharmaceutical Production License in accordance with the originally approved details.

　　Article 22: No entity or individual may forge, alter, buy, sell, lease, or lend the “Drug Production License.”

　　Article 23: The food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall, within 20 working days after completing the processing of issuing, reissuing, amending, supplementing, revoking, withdrawing, surrendering, or canceling a Drug Production License, submit a record of such actions to the National Medical Products Administration for filing. With regard to Drug Production Licenses that are legally revoked or invalidated, the issuing authority shall maintain a file and keep it on record for a period of 5 years.

　　Chapter 4: Management of Contract Manufacturing of Pharmaceuticals

　　Article 24: The commissioning party for contract manufacturing of pharmaceutical products shall be a pharmaceutical manufacturer that has obtained the approval number for such pharmaceutical products.

　　Article 25: The entrusted party for contract manufacturing of pharmaceutical products shall be a pharmaceutical manufacturer holding a Certificate of Good Manufacturing Practice for Pharmaceuticals that is commensurate with the production conditions required for the manufacture of such pharmaceutical products.

　　Article 26: The commissioning party is responsible for the quality and sales of the drugs manufactured under contract. The commissioning party shall conduct a detailed assessment of the contractor’s production conditions, production technology level, and quality management status. It shall provide the contractor with the technical and quality documentation related to the contracted drug production and shall provide guidance and supervision throughout the entire production process.

　　The entrusted party shall carry out production in accordance with the “Good Manufacturing Practice for Pharmaceuticals” and shall, as required, retain all documents and records related to the contracted production.

　　Article 27: The two parties entrusting the production of pharmaceutical products shall sign a contract whose contents shall include the rights and obligations of both parties, specifically outlining their respective rights and obligations in areas such as pharmaceutical production technology and quality control, and shall comply with the state’s laws and regulations governing pharmaceutical management.

　　Article 28: Applications for commissioned pharmaceutical manufacturing shall be受理 and approved by the food and drug administration departments of the provinces, autonomous regions, and municipalities directly under the central government where both the commissioning party and the contracted manufacturer are located.

　　Vaccine products, blood products, and other pharmaceuticals specified by the National Medical Products Administration may not be outsourced for manufacturing.

　　The commissioned production of narcotic drugs, psychotropic drugs, toxic pharmaceuticals for medical use, radioactive drugs, and drug-related precursors shall be carried out in accordance with relevant laws and regulations.

　　Article 29: For pharmaceutical products manufactured under contract, the commissioning party shall submit an application to the food and drug administration department of the province, autonomous region, or municipality directly under the central government, and provide the application materials specified in Article 33 of these Measures. The food and drug administration department shall accept the application in accordance with the provisions of Article 7 of these Measures.

　　Article 30: The food and drug administration department that accepts the application shall, within 20 working days from the date of acceptance, review the application for commissioned pharmaceutical production in accordance with the conditions stipulated in this chapter and make a decision. If a decision cannot be made within 20 working days, with approval by the head of this department, the deadline may be extended by an additional 10 working days; the applicant shall be informed of the reasons for the extension.

　　If the application is found to comply with the relevant regulations, it shall be approved, and the “Drug Contract Manufacturing Approval” shall be issued to the commissioning party within 10 working days from the date of the written approval decision. If the application does not comply with the regulations, the commissioning party shall be notified in writing, with a detailed explanation of the reasons, and informed of their right to file an administrative reconsideration or bring an administrative lawsuit in accordance with the law.

　　Article 31: The validity period of the “Drug Contract Manufacturing Approval” shall not exceed two years, nor shall it exceed the validity period specified in the drug’s approval documentation.

　　Article 32: If the “Drug Contract Manufacturing Approval” is due to expire and the commissioning party wishes to continue entrusting production, it shall, 30 days prior to the expiration date, submit the relevant materials in accordance with the provisions of Article 33 of these Measures to apply for an extension.

　　In the event that the contract for commissioned manufacturing is terminated, the commissioning party shall promptly handle the cancellation procedures for the “Drug Commissioned Manufacturing Approval.”

　　Article 33: Application Materials for Contract Manufacturing of Pharmaceuticals:

　　(1) Photocopies of the Drug Production License and Business License of both the entrusting party and the entrusted party.

　　(2) A copy of the trustee’s Certificate of Compliance with the Pharmaceutical Production Quality Management Regulations.

　　(3) The commissioning party’s assessment of the trustee’s production and quality assurance conditions.

　　(4) A copy of the approval documents for the pharmaceutical products that the commissioning party intends to outsource for production, accompanied by samples of the quality standards, manufacturing processes, packaging, labels, and instructions for use.

　　(5) The proposed formats and color codes for the packaging, labels, and instruction manuals of the drugs to be manufactured under contract.

　　(6) Contract for commissioned production.

　　(7) The inspection reports for three consecutive batches of products issued by the provincial drug testing institution in the location of the trustee. In the case of commissioned production of biological products, the three batches of samples shall be drawn and sealed by the provincial drug testing institution in the location of the trustee, and the China National Institute for Food and Drug Control shall be responsible for conducting the tests and issuing the inspection reports.

　　(8) The opinions of the food and drug administration departments of the provinces, autonomous regions, and municipalities where the trustee is located regarding their assessment of the enterprise’s technical personnel, production conditions and capabilities—including factory buildings, facilities, and equipment—as well as the quality assurance system, including quality inspection institutions and testing equipment.

　　Application materials required for the extension of pharmaceutical contract manufacturing:

　　(1) Photocopies of the Drug Production License and Business License of both the entrusting party and the entrusted party;

　　(2) A copy of the trustee’s Certificate of Compliance with the Pharmaceutical Production Quality Management Regulations;

　　(3) A copy of the previously approved “Drug Contract Manufacturing Approval”;

　　(4) A summary of the production and quality conditions during the previous contract manufacturing period;

　　(5) Supporting documents demonstrating changes from the previous “Drug Contract Manufacturing Approval.”

　　Article 34: The quality standards for drugs manufactured under contract shall comply with the national drug quality standards. The drug’s formulation, manufacturing process, packaging specifications, labels, instructions for use, and approval numbers shall be identical to those originally approved. On the packaging, labels, and instructions for use of drugs manufactured under contract, the name and registered address of the commissioning party and the name and production address of the contract manufacturer shall be clearly indicated.

　　Article 35: When reviewing applications for commissioned drug manufacturing, the food and drug administration department shall refer to and implement the relevant provisions set forth in Articles 10 through 12 of Chapter 2 of these Measures.

　　Article 36: If a pharmaceutical manufacturer accepts a commission from a foreign pharmaceutical company to process pharmaceutical products within China, it shall, within 30 days after signing the contract for commissioned production, file a record with the food and drug administration department of the province, autonomous region, or municipality directly under the central government where it is located. The pharmaceutical products thus processed may not be sold or used in any form within China.

　　Article 37: The food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall report to the National Medical Products Administration the approval and filing status of pharmaceuticals entrusted for production.

　　Chapter 5: Supervision and Inspection

　　Article 38: The food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government are responsible for the supervision and inspection of pharmaceutical manufacturing enterprises within their respective administrative jurisdictions. They shall establish operational mechanisms and management systems for conducting such supervision and inspection, and clearly define the supervisory and inspection responsibilities of the food and drug administration departments at the prefectural-level cities and county-level.

　　The National Medical Products Administration may directly conduct supervision and inspection of pharmaceutical manufacturers, and also supervise and randomly inspect the supervision and inspection work carried out by the medical products administration departments of provinces, autonomous regions, and municipalities directly under the central government, as well as the implementation and certification status of the “Good Manufacturing Practice for Pharmaceuticals” at manufacturing enterprises certified by these departments.

　　Article 39: The primary focus of supervision and inspection is the compliance of pharmaceutical manufacturers with relevant laws, regulations, and the implementation of the “Good Manufacturing Practice for Pharmaceuticals.” Such supervision and inspection includes on-site inspections for the renewal of “Pharmaceutical Production Licenses,” follow-up inspections of the “Good Manufacturing Practice for Pharmaceuticals,” and routine supervisory inspections.

　　Article 40: When organizing supervision and inspection, food and drug administration departments at all levels shall develop an inspection plan, clearly define inspection standards, and accurately record the on-site inspection conditions. The inspection results shall be communicated to the inspected entity in writing. For any items requiring rectification, the department shall specify the content of the required rectifications and the corresponding deadline, and conduct follow-up inspections to ensure compliance.

　　When conducting supervision and inspection, the food and drug administration department shall assign two or more inspectors to carry out the supervision and inspection. The inspectors shall present their law enforcement credentials to the inspected entity. Staff members of the food and drug administration department shall maintain the confidentiality of any enterprise technical secrets and business secrets they become aware of.

　　Article 41: During supervision and inspection, pharmaceutical manufacturers shall provide relevant information and the following materials:

　　(1) Self-inspection report on the company’s production status and quality management practices;

　　(2) A copy of the Pharmaceutical Production License and a copy of the Business License, as well as details on any changes to the items covered by the Pharmaceutical Production License and the corresponding approval status;

　　(3) Changes and approval status regarding the enterprise’s organizational structure, key management personnel responsible for production and quality, as well as production and inspection conditions;

　　(4) The pharmaceutical manufacturer’s compliance with supervision and inspection, as well as the implementation of corrective measures;

　　(5) The corrective measures taken following the announcement of substandard drugs in the quality bulletin;

　　(6) Other necessary materials that the examining authority needs to review.

　　After the supervision and inspection is completed, the food and drug administration department will record the inspection details on a copy of the Pharmaceutical Production License. The main contents recorded include:

　　(1) Inspection conclusion;

　　(2) Has there been a major quality incident involving the manufactured drugs? Have any substandard drugs been reported in the Drug Quality Bulletin?

　　(3) Whether the pharmaceutical manufacturer has engaged in illegal production activities, and the details of any investigations and penalties imposed.

　　Article 42: The food and drug administration departments at or above the county level shall, within the scope of their powers conferred by laws, regulations, and rules, establish regulatory files for pharmaceutical manufacturers within their administrative jurisdictions. These regulatory files shall include information such as pharmaceutical production licenses, routine inspections of production activities, random quality inspections, records of improper conduct, and records of complaints and reports.

　　Article 43: When conducting supervisory inspections, the food and drug administration department shall not impede the normal production activities of pharmaceutical manufacturers, shall not solicit or accept property from pharmaceutical manufacturers, and shall not seek any other form of benefit.

　　Article 44: Individuals and organizations that discover pharmaceutical manufacturers engaging in illegal production activities have the right to report such activities to the food and drug administration department, which shall promptly verify and address them.

　　Article 45: If there is a change in the person responsible for quality or the person in charge of production at a pharmaceutical manufacturing enterprise, the enterprise shall, within 15 days after the change, submit to the food and drug administration department of the province, autonomous region, or municipality directly under the central government where it is located a resume of the new personnel as well as relevant documentation such as educational certificates for record-keeping purposes.

　　Article 46: If any changes occur in the conditions—such as key production facilities—of a pharmaceutical manufacturer, the manufacturer shall, within 30 days of the occurrence of such changes, file a record with the food and drug administration department of the province, autonomous region, or municipality directly under the central government where it is located. The food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall conduct inspections as necessary.

　　Article 47: If a pharmaceutical manufacturer experiences a major pharmaceutical quality incident, it must immediately report the incident to the food and drug administration department and relevant authorities of the province, autonomous region, or municipality directly under the central government where it is located. The food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall, within 24 hours, report the incident to the State Administration for Food and Drug Administration.

　　Article 48: If any of the circumstances set forth in Article 70 of the Administrative Licensing Law of the People’s Republic of China (hereinafter referred to as the “Administrative Licensing Law”) apply, the original licensing authority shall revoke the Pharmaceutical Production License in accordance with the law and, within 5 working days from the date of revocation, notify the relevant administration for industry and commerce and publicly announce the revocation to the public.

　　Chapter Six: Legal Liability

　　Article 49: If any of the circumstances set forth in Article 69 of the Administrative Licensing Law apply, the National Medical Products Administration or the medical products administration authorities of provinces, autonomous regions, and municipalities directly under the central government may revoke the Pharmaceutical Production License upon request of an interested party or on their own initiative.

　　Article 50: If an applicant conceals relevant information or provides false materials when applying for a Pharmaceutical Production License, the food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall neither accept nor approve the application, issue a warning, and refuse to accept any future applications from that applicant for a period of one year.

　　If an applicant provides false materials or employs other deceptive means to obtain a Drug Production License, the food and drug administration authorities of the province, autonomous region, or municipality directly under the central government shall revoke the Drug Production License, refuse to accept any future applications from the applicant for a period of five years, and impose a fine ranging from 10,000 yuan to 30,000 yuan.

　　Article 51: Anyone who produces pharmaceutical products without obtaining a Pharmaceutical Production License shall be penalized in accordance with the provisions of Article 72 of the Drug Administration Law.

　　Article 52: Any party that, without approval, independently or by accepting a commission, engages in the production of pharmaceutical products shall be penalized according to the provisions of Article 73 of the Drug Administration Law, both the commissioning party and the contracted party.

　　Article 53: If a pharmaceutical manufacturer falls under any of the following circumstances, the food and drug administration department shall impose penalties in accordance with Article 78 of the《Drug Administration Law》:

　　(1) Pharmaceutical manufacturers fail to implement the “Good Manufacturing Practice for Pharmaceuticals” as required;

　　(2) Operating a pharmaceutical manufacturing enterprise, establishing a new pharmaceutical production workshop within a pharmaceutical manufacturing enterprise, or adding a new dosage form—yet failing to obtain certification under the Good Manufacturing Practice for Pharmaceuticals within the time frame specified in Article 6 of the Implementation Regulations of the Drug Administration Law and continuing production nonetheless.

　　Article 54: If, following supervision and inspection (including follow-up inspections and spot checks), it is determined that a pharmaceutical manufacturer fails to meet the assessment standards set forth in the “Good Manufacturing Practice for Pharmaceuticals,” the original certification authority shall, based on the inspection results, make a decision to revoke the manufacturer’s “Good Manufacturing Practice for Pharmaceuticals” certification certificate.

　　Article 55: If a pharmaceutical manufacturer falls under any of the following circumstances, the food and drug administration department of the province, autonomous region, or municipality where it is located shall issue a warning and order it to make corrections within a specified time limit. If the manufacturer fails to make corrections within the prescribed time limit, it may be fined between 5,000 yuan and 10,000 yuan:

　　(1) Failure to register changes to the items specified in the Drug Production License as required;

　　(2) Accepting commissions from overseas pharmaceutical manufacturers to process drugs within China without filing the required registration as stipulated;

　　(3) Failure to report as required when there is a change in the enterprise’s quality officer or production officer;

　　(4) If the conditions and current status of a company’s key production facilities, etc., have changed and the changes have not been filed as required;

　　(5) Failing to report a major pharmaceutical quality incident as required;

　　(6) During supervision and inspection, concealing relevant information, providing false materials, or refusing to provide the required materials.

　　Article 56: If the food and drug administration department violates regulations by issuing a Good Manufacturing Practice (GMP) certification to enterprises that do not meet the requirements of the GMP, or by failing to fulfill its duty of follow-up inspections as required for enterprises that have already obtained such certification, or by failing to order enterprises that do not meet the certification criteria to make corrections in accordance with the law, or by issuing a Drug Production License to entities that do not meet the statutory conditions, such violations shall be dealt with in accordance with the provisions of Article 93 of the Drug Administration Law.

　　Article 57: Any violation of relevant laws and regulations in the implementation of the administrative permits prescribed under these Measures shall be handled in accordance with the applicable laws and regulations.

　　Chapter 7: Appendices then

　　Article 58: The National Medical Products Administration is responsible for interpreting these Measures.

　　Article 59: The electronic certificate of drug production license issued by the food and drug administration department has the same legal effect as the printed drug production license certificate.

　　Article 60: These Measures shall take effect as of the date of their promulgation. The “Measures for the Supervision and Administration of Pharmaceutical Production” (Trial) issued by the National Medical Products Administration on December 11, 2002, shall be repealed concurrently.

　　Measures for the Supervision and Administration of Medical Device Production

　　(Announced by Order No. 7 of the State Administration for Market Regulation on July 30, 2014; amended according to 2017) On November 7, at the State Administration for Market Regulation’s Bureau Meeting, the “Decision on Amending Certain Regulations” was adopted (amended).

　　Chapter One General then

　　Article 1: In order to strengthen the supervision and management of medical device manufacturing, standardize medical device production practices, and ensure the safety and effectiveness of medical devices, these Measures are formulated in accordance with the "Regulations on the Supervision and Administration of Medical Devices."

　　Article 2: Any entity engaged in the manufacturing of medical devices and subject to supervisory management within the territory of the People’s Republic of China shall comply with these Measures.

　　Article 3: The National Medical Products Administration is responsible for the supervision and management of medical device manufacturing nationwide. Food and Drug Administration departments at or above the county level are responsible for the supervision and management of medical device manufacturing within their respective administrative areas.

　　The higher-level food and drug administration department is responsible for guiding and supervising the lower-level food and drug administration departments in carrying out the supervision and management of medical device production.

　　Article 4: The National Medical Products Administration shall formulate and supervise the implementation of Good Manufacturing Practice for medical devices.

　　Article 5: The food and drug administration department shall, in accordance with the law, promptly publish information related to medical device manufacturing licenses and filings. Applicants may inquire about the progress and outcome of their applications; the public may access the approved results.

　　Article 6: Medical device manufacturers shall be responsible for the quality of the medical devices they produce. In cases where production is outsourced, the commissioning party shall be responsible for the quality of the medical devices produced under its commission.

　　Chapter 2: Production Licensing and Filing Management

　　Article 7: To engage in the manufacture of medical devices, the following conditions must be met:

　　(1) Possess production facilities, environmental conditions, production equipment, and specialized technical personnel that are suitable for the medical devices being manufactured;

　　(2) An organization or dedicated inspection personnel equipped with inspection equipment for conducting quality inspections of manufactured medical devices;

　　(3) A management system that ensures the quality of medical devices;

　　(4) Possess after-sales service capabilities that are commensurate with the medical devices being manufactured;

　　(5) Complies with the requirements specified in the product development and manufacturing process documentation.

　　Article 8: Enterprises intending to engage in the manufacture of Class II and Class III medical devices shall apply for a manufacturing license from the food and drug administration department of the province, autonomous region, or municipality where they are located, and submit the following materials:

　　(1) A copy of the business license;

　　(2) Photocopies of the registration certificates and product technical requirements for the medical devices manufactured by the applicant enterprise;

　　(3) Photocopy of the identity document of the legal representative and the person in charge of the enterprise;

　　(4) Photocopies of identity documents, educational certificates, and professional title certificates for the persons in charge of production, quality, and technology;

　　(5) List of educational qualifications and professional titles of personnel working in production management and quality inspection positions;

　　(6) Supporting documents for the production site; if there are special requirements for the production environment, copies of supporting documents pertaining to facilities and the environment shall also be submitted.

　　(7) List of major production and inspection equipment;

　　(8) Quality manual and procedural documents;

　　(9) Process flow diagram;

　　(10) Authorization letter for the handler;

　　(11) Other supporting documents.

　　Article 9: After receiving an application, the food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall handle it accordingly based on the following circumstances:

　　(1) If the application falls within its jurisdiction and the application materials are complete and conform to the prescribed format, the application shall be accepted.

　　(2) If the application materials are incomplete or do not conform to the prescribed format, the applicant shall be notified on the spot or within 5 working days of all the items that need to be corrected. If no notification is given within the specified period, the application shall be deemed to have been accepted as of the date on which the application materials were received.

　　(3) If the application materials contain errors that can be corrected on the spot, the applicant should be allowed to correct them on the spot.

　　(4) If the application does not fall within the purview of this department’s jurisdiction, a decision rejecting the application shall be made immediately, and the applicant shall be informed to apply to the relevant administrative authority.

　　The food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall issue a notice of acceptance or non-acceptance when they accept or reject an application for a medical device manufacturing license.

　　Article 10: The food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall, within 30 working days from the date of acceptance, review the application materials and conduct on-site inspections in accordance with the requirements of the Medical Device Production Quality Management Regulations. On-site inspections shall, depending on the circumstances, avoid unnecessary duplication. If corrective actions are required, the time needed for such corrections shall not be counted toward the review deadline.

　　For those meeting the prescribed conditions, a written decision approving the permit shall be made in accordance with the law and the "Medical Device Production License" shall be issued within 10 working days. For those not meeting the prescribed conditions, a written decision denying the permit shall be made, stating the reasons therefor.

　　Article 11: Enterprises intending to engage in the production of Class I medical devices shall file a record for the production of Class I medical devices with the food and drug administration department at the prefectural-level city where they are located. They shall submit a copy of the filing certificate held by the enterprise for the medical devices it produces, as well as the materials specified in Article 8 of these Measures (except for item 2).

　　The food and drug administration shall verify on the spot the completeness of the documents submitted by enterprises. If the documents meet the prescribed requirements, they shall be filed and a Record Filing Certificate for Class I Medical Device Production shall be issued.

　　Article 12: If an application for a medical device manufacturing license directly involves significant interests between the applicant and other parties, the food and drug administration department shall inform the applicant and any interested parties of their right to request a hearing in accordance with applicable laws, regulations, and relevant provisions of the National Medical Products Administration. When reviewing applications for medical device manufacturing licenses, if the food and drug administration department deems that a licensing matter involves significant public interests, it shall publicly announce such matter and hold a hearing.

　　Article 13: The "Medical Device Production License" is valid for a period of 5 years and includes information such as the license number, enterprise name, legal representative, person in charge of the enterprise, address of domicile, production address, scope of production, issuing authority, date of issuance, and validity period.

　　The "Medical Device Production License" is accompanied by a Medical Device Product Registration Form, which lists information such as the names of the manufactured products and their registration numbers.

　　Article 14: For manufacturers of medical devices that increase their production of products, they shall submit to the original issuing authority the relevant documentation pertaining to the changes specified in Article 8 of these Measures.

　　If the products for which an application is made to add production do not fall within the original scope of production, the original issuing authority shall conduct an examination and on-site verification in accordance with the provisions of Article 10 of these Measures. If the products meet the prescribed conditions, the scope of production indicated on the Medical Device Production License shall be amended, and product information shall be recorded in the Medical Device Product Registration Form.

　　If the products applied for addition to production fall within the original scope of production and have similar requirements regarding production processes and conditions as the originally licensed products, the original issuing authority shall review the submitted documentation. If the documentation meets the prescribed conditions, the product information shall be recorded in the Medical Device Production Product Registration Form. If the production processes and conditions of the newly applied-for products differ substantially from those of the originally licensed products, the authority shall conduct a review and on-site inspection in accordance with Article 10 of these Measures. If the newly applied-for products meet the prescribed conditions, their information shall be recorded in the Medical Device Production Product Registration Form.

　　Article 15: For non-textual changes to the production address, an application for amendment of the medical device manufacturing license shall be submitted to the original licensing authority, along with the relevant documentation specified in Article 8 of these Measures pertaining to the content of the change. The original licensing authority shall review the application and conduct on-site inspections in accordance with the provisions of Article 10 of these Measures, and shall issue a decision approving or rejecting the amendment within 30 working days. If a medical device manufacturer establishes a production site across provinces, autonomous regions, or municipalities directly under the central government, it shall apply separately for a medical device manufacturing license.

　　Article 16: In the event of any changes to the enterprise name, legal representative, person in charge of the enterprise, or registered address, or any textual changes to the production address, a medical device manufacturer shall, within 30 working days after the change, apply to the original issuing authority for amendment registration of its Medical Device Production License and submit supporting documentation from the relevant authorities. The original issuing authority shall promptly process the amendment. If the submitted amendment materials are incomplete or do not comply with the requirements of the formal review, the authority shall notify the applicant once of all the items that need to be corrected.

　　Article 17: If a medical device manufacturer wishes to renew its Medical Device Production License upon expiration, it shall submit a renewal application to the original licensing authority six months prior to the expiration date.

　　The original issuing authority shall review the renewal application in accordance with the provisions of Article 10 of these Measures and, if necessary, conduct on-site inspections. A decision on whether to grant the renewal shall be made before the expiration date of the Medical Device Production License. If the applicant meets the prescribed conditions, the renewal shall be granted. If the applicant does not meet the prescribed conditions, the authority shall order corrective measures within a specified time limit. If, after making the required corrections, the applicant still fails to meet the prescribed conditions, the renewal will be denied, and the authority shall provide a written explanation of the reasons for the denial. If no decision is made within the prescribed time limit, the renewal shall be deemed to have been granted.

　　Article 18: Medical device manufacturing enterprises that continue to exist following a split or merger shall apply for a license amendment in accordance with the provisions of these Measures. Medical device manufacturing enterprises that are dissolved due to a corporate split or merger shall apply for cancellation of their "Medical Device Production License." Newly established medical device manufacturing enterprises resulting from a corporate split or merger shall apply for issuance of a "Medical Device Production License."

　　Article 19: In the event that a Medical Device Production License is lost, the medical device manufacturer shall immediately publish a notice of loss in a media outlet designated by the original licensing authority. One month after the date of publication of the notice of loss, the manufacturer may apply to the original licensing authority for a replacement license. The original licensing authority shall promptly issue the replacement Medical Device Production License.

　　Article 20: The number and validity period of a revised or reissued Medical Device Production License remain unchanged. The number of a renewed Medical Device Production License also remains unchanged.

　　Article 21: If any changes occur in the contents of the filing certificate for the production of Class I medical devices, the filing shall be amended accordingly.

　　In the event that the filing certificate is lost, the medical device manufacturer shall promptly apply to the original filing authority for a replacement.

　　Article 22: If a medical device manufacturer is subject to an investigation by the food and drug administration department for illegal production but the case has not yet been concluded, or if the manufacturer has received an administrative penalty decision but has not yet complied with it, the food and drug administration department shall suspend the licensing process until the case is resolved.

　　Article 23: If a medical device manufacturer falls under any of the circumstances stipulated by laws and regulations that require cancellation of its registration, or if the manufacturer voluntarily requests cancellation even though its license is still valid, the food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall cancel its "Medical Device Production License" in accordance with the law and publish the cancellation on their websites.

　　Article 24: The food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall establish licensing files for the issuance, renewal, modification, re-issuance, revocation, and cancellation of Medical Device Production Licenses.

　　The food and drug administration departments at the prefectural-level cities shall establish archives of registration information for Class I medical device manufacturers.

　　Article 25: No entity or individual may forge, alter, buy, sell, lease, or lend the "Medical Device Production License" or the medical device production filing certificate.

　　Chapter 3: Contract Manufacturing Management

　　Article 26: The entrusting party for commissioned manufacturing of medical devices shall be the domestic registrant or filer of the medical devices being commissioned for manufacturing. Among these, if the commissioned manufacturing involves domestic medical devices that have not been approved under the special approval procedure for innovative medical devices, the entrusting party shall obtain a manufacturing license for the commissioned medical devices or complete the filing for Class I medical device manufacturing.

　　The entrusted party for contract manufacturing of medical devices shall be a domestic manufacturer that has obtained a production license covering the relevant scope of the contracted medical device production or has completed the filing for Class I medical device production. The entrusted party shall bear corresponding responsibility for the quality of the medical devices it manufactures under contract.

　　Article 27: The commissioning party shall provide the contracting party with the quality management system documents for the commissioned medical devices as well as the product technical requirements that have been registered or filed. The commissioning party shall assess the contracting party’s production conditions, technical capabilities, and quality management competence, confirm that the contracting party possesses the necessary conditions and capabilities to carry out the commissioned production, and provide guidance and supervision over the production process and quality control.

　　Article 28: The entrusted party shall organize production in accordance with the Medical Device Production Quality Management Regulations, mandatory standards, product technical requirements, and the commissioned manufacturing contract, and shall retain all documents and records related to the entrusted production.

　　Article 29: The entrusting party and the entrusted party shall sign a contract for commissioned production, clearly defining the rights, obligations, and responsibilities of both parties.

　　Article 30: For the commissioned production of Class II and Class III medical devices, the commissioning party shall file a record of commissioned production with the food and drug administration department of the province, autonomous region, or municipality directly under the central government where it is located. For the commissioned production of Class I medical devices, the commissioning party shall file a record of commissioned production with the food and drug administration department at the prefectural-level city where it is located. If the conditions stipulated are met, the food and drug administration department shall issue a certificate of record for commissioned production of medical devices.

　　The following materials shall be submitted when filing the record:

　　(1) A copy of the registration certificate or filing voucher for medical devices manufactured under contract;

　　(2) Photocopies of the business licenses of both the entrusting party and the entrusted party;

　　(3) A copy of the trustee’s “Medical Device Production License” or the filing certificate for Class I medical device production;

　　(4) A copy of the contract for commissioned production;

　　(5) Authorization letter for the handling officer.

　　For medical devices manufactured under contract that are not subject to the special approval procedure for innovative medical devices, a copy of the contractor’s “Medical Device Production License” or the filing certificate for Class I medical device production shall also be submitted. For medical devices manufactured under contract that are subject to the special approval procedure for innovative medical devices, supporting documentation proving the special approval for innovative medical devices shall be submitted.

　　Article 31: For entrusted manufacturing of Class II and Class III medical devices, the entrusted party shall, in accordance with the provisions of Article 14 of these Measures, complete the relevant procedures and register information on the entrusted-manufactured products in the Medical Device Product Registration Form.

　　For those entrusted with the production of Class I medical devices, the entrusted party shall, in accordance with Article 21 of these Measures, submit a request to the original filing authority for an amendment to the filing for the production of Class I medical devices.

　　Article 32: When the trustee handles the addition of information on entrusted manufacturing products or changes to the filing for Class I medical device manufacturing, in addition to submitting the materials required under these Measures, the trustee shall also submit the following materials:

　　(1) Photocopies of the business licenses of both the entrusting party and the entrusted party;

　　(2) A copy of the trustee’s “Medical Device Production License” or the filing certificate for Class I medical device production;

　　(3) A copy of the filing certificate for commissioned medical device manufacturing issued by the commissioning party;

　　(4) A copy of the contract for commissioned production;

　　(5) Draft instructions and label samples to be used for the commissioned manufacturing of medical devices;

　　(6) The principal’s statement of recognition of the entrusted party’s quality management system;

　　(7) The entrusting party’s self-certification statement regarding its responsibility for the quality, sales, and after-sales service of the medical devices manufactured under contract.

　　For commissioned manufacturing of domestic medical devices that are not approved under the Special Approval Procedure for Innovative Medical Devices, a copy of the commissioning party’s “Medical Device Production License” or the filing certificate for Class I medical device production shall also be submitted. For domestic medical devices approved under the Special Approval Procedure for Innovative Medical Devices, supporting documentation proving approval under the Special Approval Procedure for Innovative Medical Devices shall be submitted.

　　Article 33: The entrusted manufacturer’s “Medical Device Production License” product registration form and the filing certificate for Class I medical device manufacturing shall clearly indicate the words “Entrusted Manufacturing” and the duration of the entrusted manufacturing arrangement.

　　Article 34: In addition to complying with relevant regulations, the instructions and labels for medical devices manufactured under contract shall also clearly indicate the contractor’s company name, registered address, production site, manufacturing license number, or production filing certificate number.

　　Article 35: Upon termination of the contract for commissioned production, both the commissioning party and the contracted party shall promptly report to the food and drug administration department at the provincial, autonomous region, municipality directly under the central government, or prefectural-level city where they are located.

　　Article 36: During the same period, the commissioning party may entrust only one medical device manufacturer (excluding wholly-owned subsidiaries) to produce the same medical device product.

　　Article 37: Implantable medical devices with high risks may not be entrusted for manufacturing. The specific catalog shall be formulated, adjusted, and published by the National Medical Products Administration.

　　Chapter 4: Production Quality Management

　　Article 38: Medical device manufacturers shall establish a quality management system in accordance with the requirements of the Medical Device Production Quality Management Regulations and ensure its effective operation.

　　Article 39: Medical device manufacturers shall conduct training on knowledge related to medical device laws, regulations, rules, and standards, and shall establish training records.

　　Production operators should possess the corresponding theoretical knowledge and practical operational skills.

　　Article 40: Medical device manufacturers shall organize production in accordance with the product technical requirements that have been registered or filed, and ensure that medical devices leaving the factory meet the mandatory standards as well as the product technical requirements that have been registered or filed. Medical devices leaving the factory must pass inspection and be accompanied by a certificate of conformity.

　　Article 41: Medical device manufacturers shall, on a regular basis, conduct a comprehensive self-inspection of the operation of their quality management systems in accordance with the requirements of the Medical Device Production Quality Management Regulations, and submit an annual self-inspection report to the food and drug administration department at the provincial, autonomous region, or municipality level—or at the prefectural-level city—before the end of each year.

　　Article 42: If the production conditions of a medical device manufacturer change and no longer meet the requirements of the medical device quality management system, the manufacturer shall immediately take corrective measures. If such changes could affect the safety or effectiveness of the medical devices, the manufacturer shall immediately cease production activities and report the situation to the county-level food and drug administration department in its jurisdiction.

　　Article 43: If a medical device product has been continuously out of production for more than one year and no similar products are currently being manufactured, the medical device manufacturer shall, prior to resuming production, submit a written report in advance to the food and drug administration department at the provincial, autonomous region, municipality directly under the central government, or prefectural-level city where it is located. Production may only be resumed after the department verifies that the manufacturer meets the required conditions.

　　Article 44: If a medical device manufacturer no longer meets the original conditions for obtaining a production license or its information does not conform to the filed records, and it is impossible to establish contact with the manufacturer, after public notice by the original licensing or filing authority, the manufacturer’s “Medical Device Production License” shall be revoked in accordance with the law, or an annotation shall be made in the filing information for Class I medical devices, and the matter shall be publicly announced to society.

　　Article 45: Medical device manufacturers shall carry out production at manufacturing sites that have been licensed or filed, and shall maintain their facilities and equipment—including production equipment, process tools, and inspection instruments—to ensure their normal operation.

　　Article 46: Medical device manufacturers shall strengthen procurement management, establish a supplier review system, evaluate suppliers, and ensure that purchased products meet statutory requirements.

　　Article 47: Medical device manufacturers shall keep records of processes such as raw material procurement, production, and inspection. These records shall be truthful, accurate, complete, and meet traceability requirements.

　　Article 48: The State encourages medical device manufacturers to adopt advanced technological means and establish information-based management systems.

　　Article 49: If a medical device manufacturer experiences a major quality incident involving its medical devices, it shall report the incident to the food and drug administration authority of the province, autonomous region, or municipality directly under the central government where it is located within 24 hours. The food and drug administration authority of the province, autonomous region, or municipality directly under the central government shall immediately report the incident to the National Medical Products Administration.

　　Chapter 5: Supervision and Management

　　Article 50: The food and drug administration department shall implement classified and graded management of medical device manufacturing in accordance with the principle of risk management.

　　Article 51: The food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall formulate supervision and inspection plans for medical device manufacturers within their administrative jurisdictions, identify key areas for medical device regulation, determine inspection frequencies and coverage rates, and oversee their implementation.

　　Article 52: Supervisory inspections of medical device manufacturing shall examine the compliance of medical device manufacturers with requirements set forth in laws, regulations, rules, standards, and other relevant provisions, with a particular focus on the matters specified in Article 53 of the "Regulations on the Supervision and Administration of Medical Devices."

　　Article 53: When the food and drug administration department organizes supervisory inspections, it shall develop an inspection plan, specify inspection standards, accurately record the on-site inspection conditions, and notify the inspected enterprise of the inspection results in writing. If corrective actions are required, the department shall clearly specify the content of the corrections and the deadline for completing them, and conduct follow-up inspections to ensure that the corrections are implemented.

　　Article 54: The food and drug administration department shall strengthen random inspections and tests of medical devices.

　　Food and Drug Administration departments at or above the provincial level shall promptly issue medical device quality announcements based on the results of spot checks and inspections.

　　Article 55: The food and drug administration department may conduct unannounced inspections of medical device manufacturers that have been identified through complaints, reports, other information, or routine supervisory checks as potentially posing safety risks to products, or of medical device manufacturers with a record of improper conduct.

　　Article 56: The food and drug administration department may hold a responsibility interview with the legal representative or person in charge of a medical device manufacturing enterprise if any of the following circumstances exist:

　　(1) Production poses serious safety hazards;

　　(2) Products that have been repeatedly reported and complained about or exposed by the media due to quality issues;

　　(3) Enterprises with a credit rating classified as “poor credit”;

　　(4) Other circumstances in which the food and drug administration department deems it necessary to conduct a responsibility interview.

　　Article 57: Food and Drug Administration departments at all local levels shall establish regulatory files for medical device manufacturers within their administrative jurisdictions. Such regulatory files shall include information on product registration and filing of medical device manufacturers, production licenses and filings, commissioned manufacturing, supervisory inspections, random sampling inspections, adverse event monitoring, product recalls, records of improper conduct, and complaints and reports.

　　Article 58: The National Medical Products Administration shall establish a unified information platform for the supervision and management of medical device manufacturing. Food and Drug Administration departments at all local levels shall strengthen their information technology infrastructure to ensure seamless information exchange.

　　Article 59: Food and Drug Administration departments at all local levels shall conduct credit evaluations of medical device manufacturers based on relevant records of their supervision and management, and establish credit files for these manufacturers. For enterprises with adverse credit records, the frequency of inspections shall be increased.

　　For enterprises listed on the “blacklist,” implement measures in accordance with the relevant regulations of the National Medical Products Administration.

　　Article 60: Individuals and organizations that discover medical device manufacturers engaging in illegal production activities have the right to report such activities to the food and drug administration department. The food and drug administration department shall promptly verify and address these reports. If the reports are verified as true, rewards shall be granted in accordance with relevant regulations.

　　Chapter Six: Legal Liability

　　Article 61: Any of the following circumstances shall be subject to the penalties prescribed in Article 63 of the "Regulations on the Supervision and Administration of Medical Devices":

　　(1) Manufacturing Class II and Class III medical devices without obtaining the medical device registration certificate;

　　(2) Engaging in the production of Class II and Class III medical devices without authorization;

　　(3) Manufacturing Class II or Class III medical devices that exceed the scope of production or are inconsistent with the products listed on the medical device product registration form;

　　(4) Manufacturing Class II and Class III medical devices at production sites without authorization;

　　(5) After the termination of contract manufacturing for Class II and Class III medical devices, if the contractor continues to manufacture the contracted products.

　　Article 62: If, after the expiration of the validity period of the Medical Device Production License, the licensee fails to apply for renewal in accordance with the law and continues to engage in the production of medical devices, they shall be penalized in accordance with the provisions of Article 63 of the Regulations on the Supervision and Administration of Medical Devices.

　　Article 63: Any entity that provides false information or employs other deceptive practices to obtain a Medical Device Production License shall be penalized in accordance with the provisions of Article 64, Paragraph 1 of the Regulations on the Supervision and Administration of Medical Devices.

　　Article 64: Any entity engaging in the production of Class I medical devices without having filed the required备案 (filing) with the food and drug administration department as prescribed shall be penalized in accordance with the provisions of Article 65, Paragraph 1 of the "Regulations on the Supervision and Administration of Medical Devices." If false information is provided during the filing process, the entity shall be penalized in accordance with the provisions of Article 65, Paragraph 2 of the "Regulations on the Supervision and Administration of Medical Devices."

　　Article 65: Those who forge, alter, trade, lease, or lend the "Medical Device Production License" shall be penalized in accordance with the provisions of Article 64, paragraph 2, of the "Regulations on the Supervision and Administration of Medical Devices."

　　Anyone who forges, alters, buys, sells, leases, or lends medical device manufacturing filing certificates shall be ordered by the food and drug administration department at or above the county level to make corrections and shall be fined no more than 10,000 yuan.

　　Article 66: Any of the following circumstances shall be subject to penalties as stipulated in Article 66 of the "Regulations on the Supervision and Administration of Medical Devices":

　　(1) Manufacturing medical devices that do not comply with mandatory standards or with the technical requirements of products that have been registered or filed;

　　(2) Medical device manufacturers fail to organize production in accordance with the technical requirements of products that have been registered or filed, or fail to establish and maintain an effective quality management system as required by these Measures;

　　(3) Entrusting the production of medical devices to enterprises that do not meet the conditions stipulated in these Measures, or failing to manage the production activities of the entrusted party.

　　Article 67: If the production conditions of a medical device manufacturer change and no longer meet the requirements of the medical device quality management system, and the manufacturer fails to make rectifications, cease production, or report as required under these Measures, it shall be penalized in accordance with Article 67 of the "Regulations on the Supervision and Administration of Medical Devices."

　　Article 68: If a medical device manufacturer fails to submit, as required, a self-inspection report on the operation of its quality management system to the food and drug administration department at the provincial, autonomous region, or municipality level, or at the prefectural-level city, it shall be penalized in accordance with the provisions of Article 68 of the "Regulations on the Supervision and Administration of Medical Devices."

　　Article 69: In any of the following circumstances, the food and drug administration department at or above the county level shall issue a warning, order rectification within a specified time limit, and may also impose a fine of up to 30,000 yuan:

　　(1) Medical devices leaving the factory have not been inspected in accordance with the prescribed requirements;

　　(2) Medical devices leaving the factory without being accompanied by the required certificates of conformity as stipulated;

　　(3) Failure to register the amendment of the Medical Device Production License in accordance with Article 16 of these Measures;

　　(4) Failure to register the commissioned production as required;

　　(5) Medical device products that have been continuously discontinued for more than one year and for which no similar products are currently being manufactured may resume production without prior verification by the food and drug administration department at the provincial, autonomous region, or municipality level, or at the prefectural-level city level, provided they meet the required standards.

　　(6) Concealing relevant information from, providing false data to, or refusing to provide authentic records reflecting its activities to the food and drug administration department responsible for supervision and inspection.

　　If any of the circumstances listed in the preceding paragraph are serious in nature or have caused harmful consequences and constitute a violation of relevant provisions of the "Regulations on the Supervision and Administration of Medical Devices," penalties shall be imposed in accordance with the provisions of the "Regulations on the Supervision and Administration of Medical Devices."

　　Chapter 7: Appendices then

　　Article 70: Manufacturers of medical devices intended for export shall ensure that their manufactured medical devices comply with the requirements of the importing country (or region) and shall file relevant product information with the food and drug administration department at the prefectural-level city where they are located.

　　If a manufacturing enterprise accepts a commission from a foreign entity to produce medical devices that are marketed and sold overseas, it shall obtain third-party certification of its medical device quality management system or obtain a domestic production license or filing for similar products.

　　Article 71: The formats of the "Medical Device Production License" and the Filing Certificate for Class I Medical Device Production shall be uniformly prescribed by the National Medical Products Administration.

　　The "Medical Device Production License" is printed by the food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government.

　　The numbering format for the "Medical Device Production License" is: × Food and Drug Administration Medical Device Production License No. ××××××××. Among these:

　　The first × represents the abbreviation of the province, autonomous region, or municipality where the licensing authority is located;

　　Positions 2 through 5 × represent the 4-digit license year;

　　Positions 6 through 9 × represent a 4-digit license serial number.

　　The format for the filing number of the registration certificate for Class I medical device manufacturing is: ×× Food and Drug Administration Medical Device Production Filing No. ××××××××. Among these:

　　The first × represents the abbreviation of the province, autonomous region, or municipality where the filing authority is located;

　　The second digit × represents the abbreviation of the prefectural-level administrative region where the filing authority is located;

　　Positions 3 through 6 × represent the 4-digit registration year;

　　Positions 7 through 10, marked with an ×, represent the 4-digit registration serial number.

　　Article 72: The electronic certificate of medical device production license issued by the food and drug administration department has the same legal effect as the printed medical device production license certificate.

　　Article 73: These Measures shall take effect as of October 1, 2014. The “Measures for the Supervision and Administration of Medical Device Production,” promulgated on July 20, 2004 (Order No. 12 of the State Food and Drug Administration), shall be repealed concurrently.