Order of the State Administration for Market Regulation

No. 27

　　The “Administrative Measures for Drug Registration” were reviewed and approved at the 1st Bureau Meeting of the State Administration for Market Regulation in 2020 on January 15, 2020. They are hereby promulgated and shall take effect as of July 1, 2020.

　　Director Xiao Yaqing

　　January 22, 2020

　　Drug Registration Management Measures

　　(Promulgated by Order No. 27 of the State Administration for Market Regulation on January 22, 2020)

　　Chapter 1 General Provisions

　　Article 1: In order to standardize drug registration practices and ensure the safety, efficacy, and controllable quality of drugs, these Measures are formulated in accordance with the Drug Administration Law of the People’s Republic of China (hereinafter referred to as the “Drug Administration Law”), the Traditional Chinese Medicine Law of the People’s Republic of China, the Vaccine Administration Law of the People’s Republic of China (hereinafter referred to as the “Vaccine Administration Law”), the Administrative Licensing Law of the People’s Republic of China, and the Implementation Regulations of the Drug Administration Law of the People’s Republic of China, as well as other relevant laws and administrative regulations.

　　Article 2: This Regulation applies to activities related to drug research and development, registration, and regulatory oversight conducted within the territory of the People’s Republic of China with the purpose of bringing drugs to market.

　　Article 3: Drug registration refers to the activities in which a drug registration applicant (hereinafter referred to as the applicant) submits applications—including applications for clinical trials, marketing authorization, re-registration, and supplementary applications—in accordance with statutory procedures and relevant requirements. The drug regulatory authority conducts reviews based on laws and regulations as well as existing scientific knowledge to assess the safety, efficacy, and controllability of quality, and then decides whether to approve the applicant’s application.

　　After obtaining the drug registration certificate, the applicant becomes the marketing authorization holder (hereinafter referred to as the “holder”).

　　Article 4: Drug registration shall be categorized and managed according to types such as traditional Chinese medicine, chemical drugs, and biological products.

　　Traditional Chinese medicine registration is categorized into innovative TCM drugs, improved new TCM drugs, compound preparations of time-honored classic prescriptions, and drugs with the same name and formula.

　　Chemical drug registration is categorized into innovative chemical drugs, improved new chemical drugs, and generic drugs.

　　Biological product registration is categorized into innovative biological drugs, improved new biological drugs, and already-marketed biological products (including biosimilars).

　　The detailed classification of pharmaceutical products—including traditional Chinese medicines, chemical drugs, and biological products—and the corresponding requirements for submission of application materials shall be formulated by the National Medical Products Administration based on the product characteristics, degree of innovation, and review and regulatory needs of registered drugs, and shall be publicly announced to the public.

　　Registration applications for pharmaceutical products manufactured overseas shall be submitted in accordance with the detailed classification of pharmaceuticals and the corresponding requirements for submission documents.

　　Article 5: The National Medical Products Administration (NMPA) is in charge of drug registration management nationwide. It is responsible for establishing the system and mechanisms for drug registration management, formulating standards for drug registration management, and organizing, in accordance with the law, the review and approval of drug registrations as well as related supervisory and administrative work. The Drug Review Center of the NMPA (hereinafter referred to as the Drug Review Center) is responsible for reviewing applications for clinical trials of drugs, applications for marketing authorization, supplementary applications, and re-registration applications for drugs manufactured overseas. The China National Institute for Food and Drug Control (hereinafter referred to as the CNIFDC), the National Pharmacopoeia Committee (hereinafter referred to as the Pharmacopoeia Committee), the Center for Food and Drug Inspection and Verification of the NMPA (hereinafter referred to as the Drug Inspection and Verification Center), the Drug Evaluation Center of the NMPA (hereinafter referred to as the Drug Evaluation Center), the NMPA’s Service Center for Accepting Administrative Matters and Handling Complaints and Reports, and the NMPA’s Information Center (hereinafter referred to as the Information Center), among other specialized pharmaceutical institutions, undertake tasks such as drug registration testing, approval of generic names, inspection, monitoring and evaluation, issuance and delivery of certificates, and related informationization construction and management required for the lawful implementation of drug registration management.

　　Article 6: The drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the central government are responsible for the following drug registration-related management tasks within their respective administrative areas:

　　(1) Acceptance, review, and approval of re-registration applications for pharmaceutical products manufactured within the territory;

　　(2) Management of filing and reporting requirements for post-marketing changes to pharmaceutical products;

　　(3) Organize daily supervision of non-clinical safety evaluation institutions and clinical trial institutions for drugs, as well as investigate and deal with any illegal activities.

　　(4) Participate in drug registration inspections, testing, and other related work organized by the National Medical Products Administration;

　　(5) Drug registration-related matters entrusted to the National Medical Products Administration for implementation.

　　The pharmaceutical professional technical institutions established or designated by the drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the central government shall undertake tasks such as review, inspection, verification, monitoring, and evaluation required for the lawful implementation of drug regulatory oversight.

　　Article 7: Drug registration management shall adhere to the principles of openness, fairness, and impartiality, be guided by clinical value, encourage research and development of new drugs, and actively promote the development of generic drugs.

　　The National Medical Products Administration continues to advance the reform of the review and approval system, optimize review and approval procedures, enhance review and approval efficiency, and establish a drug registration management system that is led by review and supported by testing, verification, monitoring, and evaluation.

　　Chapter 2: Basic Systems and Requirements

　　Article 8: Any entity engaged in drug research and development and drug registration activities shall comply with applicable laws, regulations, rules, standards, and guidelines. If other evaluation methods and techniques are adopted in reference to relevant technical guidance principles, their scientific validity and applicability must be demonstrated. Furthermore, the entity shall ensure that all information throughout the entire process is authentic, accurate, complete, and traceable.

　　Medicines shall comply with the national pharmaceutical standards and the drug quality standards approved by the National Medical Products Administration. The drug quality standards approved by the National Medical Products Administration constitute the drug registration standards. Such drug registration standards shall meet the general technical requirements set forth in the Pharmacopoeia of the People’s Republic of China and shall not be lower than the provisions stipulated in the Pharmacopoeia of the People’s Republic of China. If the testing items or indicators submitted for registration do not conform to the requirements of the Pharmacopoeia of the People’s Republic of China, the applicant shall provide sufficient supporting data.

　　Technical institutions such as the Drug Review Center shall, based on scientific advancements, actual developments in the industry, and the needs of drug regulatory oversight, formulate technical guidance principles and procedures and make them publicly available.

　　Article 9: The applicant shall be an enterprise or a pharmaceutical research and development institution capable of assuming the corresponding legal responsibilities. For applicants located outside China, a corporate legal entity within China must be designated to handle the relevant drug registration matters.

　　Article 10: Before applying for marketing authorization of a drug, the applicant shall have completed relevant studies, including pharmaceutical studies, pharmacological and toxicological studies, and clinical trials of the drug. Non-clinical safety evaluation studies of the drug shall be conducted by institutions that have been certified in accordance with the Good Clinical Practice for Non-clinical Studies and shall comply with the Good Clinical Practice for Non-clinical Studies. Clinical trials of the drug shall be approved; among these, bioequivalence studies shall be filed. Clinical trials of the drug shall be conducted at clinical trial institutions that meet the relevant requirements and shall comply with the Good Clinical Practice for Clinical Trials.

　　To apply for drug registration, one must provide authentic, sufficient, and reliable data, documentation, and samples to demonstrate the safety, efficacy, and controllability of quality of the drug.

　　When using overseas research data and information to support drug registration, the sources of such data, the conditions of the research institutions or laboratories, quality system requirements, and other management conditions shall comply with the prevailing principles of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, as well as with the relevant requirements for drug registration in China.

　　Article 11: If an applicant seeks to change any item or content specified in the original drug registration approval document and its appendices, the applicant shall, in accordance with applicable regulations and with reference to relevant technical guidance principles, conduct thorough research and verification on the drug change, fully assess the potential impact of the change on the drug’s safety, efficacy, and quality control, and submit a supplementary application, file a record, or make a report according to the prescribed change procedures.

　　Article 12: The validity period of a drug registration certificate is five years. During the validity period of the drug registration certificate, the holder shall continuously ensure the safety, efficacy, and controllable quality of the marketed drug, and shall apply for re-registration of the drug six months before the expiration date.

　　Article 13: The National Medical Products Administration shall establish a system for accelerated drug registration to support drug innovation guided by clinical value. Applicants may, for drug registration applications that meet the relevant criteria, request to apply the breakthrough therapy designation, conditional approval, priority review and approval, and special approval procedures. During the drug development and registration process, the drug regulatory authority and its specialized technical institutions shall provide necessary technical guidance, facilitate communication and exchange, prioritize resource allocation, and shorten review timelines, among other policy and technical supports.

　　Article 14: The National Medical Products Administration shall establish a system of linked review and approval for chemical active pharmaceutical ingredients, excipients, and packaging materials and containers that are in direct contact with drugs. When reviewing and approving drug preparations, the chemical active pharmaceutical ingredients shall be reviewed and approved concurrently, along with the associated excipients and packaging materials and containers that are in direct contact with the drugs. The Drug Review Center shall establish an information registration platform for chemical active pharmaceutical ingredients, excipients, and packaging materials and containers that are in direct contact with drugs, publicly disclose the relevant registration information for selection by applicants or holders, and link such information to the review and approval process of related drug preparation registration applications.

　　Article 15: Prescription drugs and over-the-counter (OTC) drugs shall be subject to classified registration and conversion management. The Drug Review Center, based on the characteristics of OTC drugs, shall develop technical guidance principles and procedures for the marketing registration of OTC drugs and make them publicly available. The Drug Evaluation Center shall formulate technical requirements and procedures for the post-marketing conversion between prescription drugs and OTC drugs and also make them publicly available.

　　Article 16: Before submitting an application for a clinical trial of a drug, during the clinical trial process, and prior to applying for marketing authorization, applicants may communicate and exchange information with specialized technical agencies such as the Drug Review Center on key issues. During the drug registration process, the Drug Review Center and other specialized technical agencies may, as needed, organize communication and exchanges with the applicant.

　　The procedures, requirements, and time limits for communication and exchange shall be formulated separately by specialized technical institutions such as the Drug Review Center according to their respective functions and shall be publicly announced.

　　Article 17: The Drug Review Center and other specialized technical institutions shall establish an expert consultation system and set up an Expert Advisory Committee as needed for their work. During the review, verification, inspection, and generic name approval processes, they shall solicit expert opinions on significant issues and fully leverage the technical support provided by experts.

　　Article 18: The National Medical Products Administration shall establish a catalog of chemically synthesized drugs that have been newly approved for marketing and those that have passed the evaluation of consistency in quality and efficacy with reference drugs. This catalog shall include information such as drug names, active ingredients, dosage forms, specifications, whether the drug is a reference preparation, and the holder of the marketing authorization, and shall be updated promptly and made publicly available. The procedures and requirements for including drugs in the catalog shall be formulated by the Center for Drug Evaluation and publicly announced.

　　Article 19: The National Medical Products Administration supports the inheritance and innovation of traditional Chinese medicine (TCM), establishes and improves a registration management system and a technical evaluation framework that are tailored to the characteristics of TCM, encourages the use of modern scientific and technological methods as well as traditional research approaches in the development of TCM products, strengthens quality control over TCM products, and enhances the standards of clinical trials for TCM.

　　For a traditional Chinese medicine registration application, the applicant shall conduct a clinical value and resource assessment, emphasizing a clinical-value-oriented approach and promoting the sustainable use of resources.

　　Chapter 3: Drug Marketing Registration

　　Section 1: Clinical Trials of Drugs

　　Article 20: The drug clinical trials referred to in these Measures are studies conducted on human subjects with the purpose of obtaining marketing authorization for a drug, aimed at determining the safety and efficacy of the drug.

　　Article 21: Clinical trials of drugs are classified into Phase I clinical trials, Phase II clinical trials, Phase III clinical trials, Phase IV clinical trials, and bioequivalence studies. Depending on the characteristics of the drug and the objectives of the study, the research content may include clinical pharmacology studies, exploratory clinical trials, confirmatory clinical trials, and post-marketing studies.

　　Article 22: Clinical trials of drugs shall be conducted at clinical trial institutions that meet the relevant requirements and have been filed in accordance with regulations. In particular, vaccine clinical trials shall be carried out or organized by tertiary medical institutions or disease prevention and control institutions at or above the provincial level that meet the conditions stipulated by the National Medical Products Administration and the National Health Commission.

　　Article 23: If an applicant, after completing pharmaceutical, pharmacological, and toxicological studies supporting clinical trials of a drug, submits an application for clinical trials, it shall submit the relevant study data in accordance with the requirements for submission documents. Upon formal review, if the submitted documents meet the requirements, the application shall be accepted. The Drug Review Center shall organize pharmaceutical, medical, and other technical personnel to conduct a review of the accepted clinical trial applications. A decision on whether to approve the initiation of clinical trials shall be made within sixty days from the date of acceptance, and the applicant shall be notified of the approval result via the Drug Review Center’s website. If no notification is received within the specified period, the application shall be deemed approved, and the applicant may proceed with the clinical trials according to the submitted protocol.

　　The applicant authorized to conduct clinical trials of a drug is the sponsor of the clinical trial (hereinafter referred to as the “sponsor”).

　　Article 24: If an applicant intends to conduct a bioequivalence study, it shall, as required, complete the registration of the bioequivalence study on the website of the Drug Review Center and then carry out the relevant research work in accordance with the registered protocol.

　　Article 25: Clinical trials of drugs shall be conducted only after obtaining approval from the ethics committee.

　　The management of investigational medicinal products used in clinical trials shall comply with the relevant requirements of the Good Clinical Practice for Drug Clinical Trials.

　　Article 26: Applicants who have been approved to conduct clinical trials of drugs shall, prior to initiating subsequent-phase clinical trials, develop a corresponding clinical trial protocol. Such protocol shall be submitted to the Ethics Committee for review and approval before commencement, and the applicant shall also submit the relevant clinical trial protocol and supporting documentation to the website of the Drug Review Center.

　　Article 27: If a drug that has been approved to conduct clinical trials is intended to add new indications (or primary therapeutic uses) or to be used in combination with other drugs, the applicant shall submit a new application for clinical trials. Only after such application has been approved may the new clinical trials be conducted.

　　If a drug that has been approved for marketing is to add new indications (or new intended uses), and such addition requires conducting clinical trials, a new clinical trial application must be submitted.

　　Article 28: The applicant shall periodically submit safety update reports during the research and development phase on the website of the Drug Review Center. The safety update report during the R&D phase shall be submitted once a year, within two months after each full year following the approval of the clinical trial for the drug. Based on the review findings, the Drug Review Center may require the applicant to adjust the reporting cycle.

　　For suspected and unexpected serious adverse reactions and other potential serious safety risks that arise during clinical trials of drugs, the sponsor shall promptly report such information to the Center for Drug Evaluation in accordance with relevant requirements. Depending on the severity of the safety risk, the sponsor may be required to take measures—such as adjusting the clinical trial protocol, informed consent form, or investigator’s brochure—to strengthen risk control. If necessary, the sponsor may also be required to suspend or terminate the clinical trial.

　　The specific requirements for safety update reports during the R&D period are formulated and published by the Center for Drug Evaluation.

　　Article 29: During a drug clinical trial, if there are any changes to the clinical trial protocol, non-clinical or pharmaceutical changes, or new findings, the sponsor shall, in accordance with applicable regulations and referring to relevant technical guidance principles, thoroughly assess the potential impact on the safety of the subjects.

　　If the applicant assesses that a proposed change does not affect the safety of the subjects, it may be implemented directly and reported in the safety update report during the research and development phase. If the proposed change could increase the safety risks to the subjects, a supplementary application must be submitted. The decision on whether to approve the supplementary application shall be made within 60 days from the date of receipt, and the applicant will be notified of the approval result via the website of the Drug Review Center. If no notification is provided within the specified period, the application shall be deemed approved.

　　If the sponsor undergoes a change, the responsibility and obligations related to the clinical trial of the drug shall be assumed by the new sponsor.

　　Article 30: During a drug clinical trial, if safety issues or other risks are identified, the sponsor shall promptly adjust the clinical trial protocol, suspend or terminate the clinical trial, and report to the Center for Drug Evaluation.

　　If any of the following circumstances exist, the applicant may be required to adjust the clinical trial protocol, suspend, or terminate the drug clinical trial:

　　(1) The ethics committee has failed to fulfill its duties;

　　(2) Those that cannot effectively ensure the safety of subjects;

　　(3) The applicant has failed to submit the safety update report during the R&D period as required;

　　(4) The sponsor failed to promptly address and report suspected, unexpected, serious adverse reactions;

　　(5) There is evidence demonstrating that the investigational drug is ineffective;

　　(6) When quality issues arise with drugs used in clinical trials;

　　(7) Falsifying data during clinical trials of drugs;

　　(8) Other circumstances that violate the Good Clinical Practice for Drug Clinical Trials.

　　In the event of widespread, unexpected serious adverse reactions occurring in a clinical trial of a drug, or when there is evidence indicating that the investigational drug has serious quality issues, the sponsor and the clinical trial institution shall immediately halt the clinical trial. The drug regulatory authority, within its jurisdiction, may order adjustments to the clinical trial protocol, or suspend or terminate the clinical trial.

　　Article 31: After a drug clinical trial has been ordered to be suspended, if the sponsor intends to resume the drug clinical trial, it shall submit a supplementary application for resuming the drug clinical trial after completing the required rectifications. The drug clinical trial may only be resumed upon approval following review. If the suspension period of a drug clinical trial reaches three years and no application for resumption has been submitted and approved, the license for that drug clinical trial shall become automatically invalid.

　　If a clinical trial of a drug is terminated and the sponsor intends to continue conducting the clinical trial, a new application for the clinical trial of the drug must be submitted.

　　Article 32: Clinical trials of pharmaceuticals shall be conducted within three years following approval. If, from the date of approval, no subjects have signed informed consent forms within three years, the clinical trial authorization for that pharmaceutical shall automatically become invalid. Should it still be necessary to conduct the clinical trial, a new application must be submitted.

　　Article 33: Before initiating a clinical trial of a drug, the sponsor shall register information such as the clinical trial protocol on the Clinical Trial Registration and Information Disclosure Platform for Drugs. During the course of the clinical trial, the sponsor shall continuously update the registered information and, upon completion of the clinical trial, shall register information including the results of the clinical trial. The registered information will be publicly disclosed on the platform, and the sponsor shall be responsible for the authenticity of the information registered for the clinical trial.

　　The specific requirements for the registration and public disclosure of clinical trials of pharmaceuticals shall be formulated and announced by the Center for Drug Evaluation.

　　Section 2: Marketing Authorization for Pharmaceuticals

　　Article 34: After the applicant has completed the necessary research—including pharmaceutical studies, pharmacological and toxicological studies, and clinical trials—to support the drug’s marketing registration, established quality standards, validated the commercial-scale manufacturing process, and prepared adequately for the drug registration inspection and testing, the applicant may submit an application for drug marketing authorization, providing the relevant study data as required by the submission guidelines. Upon formal review of the submitted documentation, if the documentation meets the requirements, it will be accepted.

　　Article 35: For generic drugs, in vitro diagnostic reagents regulated as pharmaceutical products, and other circumstances meeting the relevant conditions, if the applicant assesses that clinical trials of the drug are unnecessary or cannot be conducted and determines that the conditions for exemption from clinical trials are met, the applicant may directly submit an application for marketing authorization. The technical guidance principles and specific requirements for exempting clinical trials shall be formulated and published by the Center for Drug Evaluation.

　　Generic drugs shall be consistent with the reference listed drug in terms of quality and therapeutic efficacy. Applicants shall select a reasonable reference listed drug by referring to the relevant technical guidance principles.

　　Article 36: An application for marketing authorization of over-the-counter drugs may be submitted directly if any of the following circumstances is met:

　　(1) Medicines for which over-the-counter drugs with the same active ingredient, indications (or main functions and indications), dosage forms, and specifications are already available in the domestic market;

　　(2) Over-the-counter drugs whose dosage form or specification has been changed as determined by the National Medical Products Administration, but without altering the indications (or main therapeutic functions), dosing regimen, or route of administration;

　　(3) New combination formulations composed of active ingredients from over-the-counter drugs identified by the National Medical Products Administration;

　　(4) Other circumstances involving direct submission for marketing authorization of over-the-counter drugs.

　　Article 37: If the proposed generic name of a drug to be submitted for approval is not listed in the National Drug Standards or the Drug Registration Standards, the applicant shall simultaneously submit an application for approval of the generic name when filing the application for marketing authorization. After the marketing authorization application is accepted, the relevant materials for generic name approval will be forwarded to the Pharmacopoeia Committee. Following approval by the Pharmacopoeia Committee, the feedback will be provided to the Drug Review Center.

　　If the proposed generic name of a drug to be submitted has already been included in the National Drug Standards or the Drug Registration Standards, and the Drug Review Center deems it necessary to approve the generic name during the review process, it shall notify the Pharmacopoeia Committee to approve the generic name and provide the relevant documentation. After the Pharmacopoeia Committee approves the generic name, it shall provide feedback to the Drug Review Center.

　　When approving generic names for pharmaceutical products, the Pharmacopoeia Committee shall maintain effective communication and exchange with the applicant and shall notify the applicant of the approval results.

　　Article 38: The Drug Review Center shall organize pharmaceutical, medical, and other technical personnel to review, as required, the marketing authorization applications for drugs that have been accepted.

　　During the review process, if risk-based drug registration inspections and tests are initiated, the relevant technical agencies shall complete the inspections and tests within the prescribed time limits.

　　Based on the drug registration application data, inspection results, and testing results, the Drug Review Center conducts a comprehensive evaluation of the drug’s safety, efficacy, and quality controllability. For over-the-counter (OTC) drugs, the review process also includes forwarding the application to the Drug Evaluation Center for an appropriateness assessment of OTC status.

　　Article 39: If the comprehensive review and assessment conclusion is favorable, the drug shall be approved for marketing and a drug registration certificate shall be issued. If the comprehensive review and assessment conclusion is unfavorable, a decision of non-approval shall be made. The drug registration certificate shall specify information such as the drug approval number, holder, and manufacturer. For over-the-counter drugs, the drug registration certificate shall also indicate the category of over-the-counter drug.

　　The approved pharmaceutical manufacturing processes, quality standards, package inserts, and labels shall be issued to the applicant as Annex I to the drug registration certificate. Where necessary, requirements for post-marketing studies shall also be attached. The aforementioned information shall be incorporated into the drug dossier and updated promptly in light of any post-marketing changes.

　　After a drug is approved for marketing, the holder shall manufacture the drug in accordance with the production processes and quality standards approved by the National Medical Products Administration, and shall further refine and implement these requirements in compliance with the Good Manufacturing Practice for Pharmaceutical Products.

　　Article 40: During the review period of a drug marketing authorization application, if significant changes occur that may affect the safety, efficacy, or controllability of the drug’s quality, the applicant shall withdraw the original registration application and resubmit it after conducting additional studies.

　　If the change involves only the applicant’s name or the name of the registered address and does not affect the technical review content, the applicant shall promptly notify the Drug Review Center in writing and submit the relevant supporting documentation.

　　Section 3: Related Review and Approval

　　Article 41: When reviewing applications for registration of pharmaceutical preparations, the Center for Drug Evaluation shall conduct a linked review of the chemical active pharmaceutical ingredients, excipients, and packaging materials and containers that come into direct contact with the drug product.

　　Enterprises manufacturing chemical APIs, excipients, and packaging materials and containers that come into direct contact with drugs shall, in accordance with the requirements of the associated review and approval system, register product information and research data on the registration platform for chemical APIs, excipients, and packaging materials and containers that come into direct contact with drugs. The Center for Drug Evaluation will publicly disclose basic information such as registration numbers, product names, enterprise names, and production addresses, enabling applicants for drug formulation registration to make their selections.

　　Article 42: An applicant for pharmaceutical preparations may directly use chemically active ingredients, excipients, and packaging materials and containers that have already been registered when submitting a drug registration application. If the applicant chooses to use chemically active ingredients, excipients, or packaging materials and containers that have not yet been registered, the relevant research data shall be submitted together with the pharmaceutical preparation registration application.

　　Article 43: When reviewing applications for drug product registration, the Center for Drug Evaluation shall conduct a linked review of the chemical APIs, excipients, and packaging materials and containers that directly contact the drug product. If additional data are required, the applicant for the drug product or the registrant of the chemical APIs, excipients, and packaging materials and containers that directly contact the drug product shall provide such supplementary data in accordance with the procedures for submitting supplementary information. Based on risk considerations, the Center may also propose extending inspections to the enterprises producing the chemical APIs, excipients, and packaging materials and containers that directly contact the drug product.

　　Chemical APIs used in the manufacture of domestically marketed drugs that are being imitated may be subject to separate review and approval applications.

　　Article 44: For chemical APIs, excipients, and packaging materials and containers that directly contact drugs, if their associated review has been approved or if they have undergone separate review and approval, the Center for Drug Evaluation will update the registration status indicator on the registration platform for chemical APIs, excipients, and packaging materials and containers that directly contact drugs, and publicly disclose relevant information to the public. In particular, for chemical APIs, both the Approval Notice for Chemical APIs and the approved manufacturing process, quality standards, and labeling will be issued simultaneously; the Approval Notice for Chemical APIs will include the registration number. If an application is not approved, a Notice of Non-Approval for Chemical APIs will be issued.

　　For those that have not passed the associated review and approval, the registration status of chemical APIs, excipients, and packaging materials and containers that directly contact pharmaceutical products will remain unchanged, and applications for related pharmaceutical preparations will not be approved.

　　Section 4: Drug Registration Inspection

　　Article 45: The drug registration inspection refers to the verification activities conducted at the drug development and manufacturing sites to confirm the authenticity and consistency of the submitted documentation, as well as the commercial production conditions for the drug’s market launch. These activities also include assessing the compliance of drug development processes and the reliability of data. When necessary, extended inspection activities may be carried out on manufacturers, suppliers, or other entrusted entities involved in the drug registration application, including those producing active pharmaceutical ingredients, excipients, and packaging materials and containers that come into direct contact with the drug.

　　The principles, procedures, time limits, and requirements for initiating drug registration inspections shall be formulated and announced by the Drug Review Center; the principles, procedures, time limits, and requirements for conducting drug registration inspections shall be formulated and announced by the Drug Inspection Center.

　　Article 46: Based on the degree of drug innovation and the previous inspection records of the drug research institution, the Drug Review Center shall determine, on a risk-based approach, whether to conduct on-site inspections of drug registration and development.

　　If the Drug Review Center decides to initiate on-site inspections of drug registration and development, it shall notify the Drug Inspection Center to organize and carry out the inspections during the review period and simultaneously inform the applicant. The Drug Inspection Center shall complete the on-site inspection within the prescribed time limit and submit the inspection findings, inspection conclusions, and other relevant materials to the Drug Review Center for comprehensive review.

　　Article 47: Based on factors such as the variety, process, facilities, and previous inspection records of the submitted registration application, the Center for Drug Evaluation will determine, on the basis of risk assessment, whether to initiate on-site inspections of drug manufacturing facilities for registration purposes.

　　For innovative drugs, improved new drugs, and biological products, on-site inspections of drug registration manufacturing facilities and pre-marketing Good Manufacturing Practice (GMP) inspections of drug production shall be conducted.

　　For generic drugs and the like, based on factors such as whether the manufacturer has obtained the relevant drug production license for the corresponding product scope and whether similar formulations have already been marketed, on-site inspections of drug registration and pre-market Good Manufacturing Practice (GMP) inspections will be conducted according to risk assessment.

　　Article 48: After a drug registration application is accepted, the Drug Review Center shall conduct a preliminary review within forty days of acceptance. If on-site inspection of the drug’s manufacturing facility is required, the Drug Inspection Center shall be notified to organize and carry out the inspection, provide the materials necessary for the inspection, and simultaneously inform the applicant as well as the drug regulatory authorities of the province, autonomous region, or municipality where the applicant or the manufacturing enterprise is located. In principle, the Drug Inspection Center shall complete the inspection work no later than forty days before the expiration of the review period and shall promptly feed back to the Drug Review Center information regarding the inspection status, inspection results, and other relevant materials.

　　For pre-market inspections of Good Manufacturing Practice for pharmaceutical products, the Drug Inspection Center will coordinate with the drug regulatory authorities of relevant provinces, autonomous regions, and municipalities directly under the central government to conduct these inspections concurrently with on-site inspections of drug registration and manufacturing. The management requirements for pre-market inspections of Good Manufacturing Practice shall be implemented in accordance with the relevant provisions of the Measures for the Supervision and Administration of Pharmaceutical Production.

　　The applicant shall undergo verification within the prescribed time limit.

　　Article 49: During the review process, if the Center for Drug Evaluation finds that the authenticity of the submitted documentation is questionable or there are clear leads indicating potential issues requiring on-site verification, it shall initiate a targeted inspection and, if necessary, conduct sample testing.

　　Article 50: When applying for marketing authorization of a drug, the applicant and the manufacturing enterprise shall have already obtained the corresponding drug production license.

　　Section 5: Drug Registration Testing

　　Article 51: Drug registration testing includes standard review and sample testing. Standard review refers to the laboratory evaluation conducted to assess the scientific validity of the items specified in the drug standards submitted by the applicant, the feasibility of the testing methods employed, and the reasonableness of the quality control indicators. Sample testing refers to the laboratory examination of samples performed in accordance with the drug quality standards submitted by the applicant or approved by the Drug Review Center.

　　The principles, procedures, time limits, and other requirements for initiating drug registration testing shall be formulated and published by the Center for Drug Evaluation. The specific procedures and requirements for drug registration testing, as well as the technical requirements and standards for drug registration testing, shall be formulated and published by the National Institute for Control of Pharmaceutical and Biological Products prior to the acceptance of drug registration applications.

　　Article 52: If the testing items and testing methods used for a drug of the same type as those included in the National Drug Standards are consistent, standard review may be waived, and only sample testing shall be conducted. In all other cases, both standard review and sample testing shall be carried out.

　　Article 53: The National Institute for Drug Control or a drug testing institution designated by the National Medical Products Administration shall undertake the following drug registration tests:

　　(1) Innovative drugs;

　　(2) Improved new drugs (excluding traditional Chinese medicines);

　　(3) Biological products, radioactive drugs, and in vitro diagnostic reagents managed as pharmaceuticals;

　　(4) Other drugs specified by the National Medical Products Administration.

　　The registration testing of pharmaceutical products manufactured overseas is conducted by the National Institute for Drug Control, in collaboration with port-based drug inspection agencies.

　　The registration testing of other pharmaceutical products shall be conducted by the provincial drug testing institution located in the place where the applicant or the manufacturing enterprise is based.

　　Article 54: After the applicant has completed pharmaceutical studies supporting the drug’s marketing, established quality standards, and validated the commercial-scale manufacturing process, the applicant may, prior to the acceptance of the drug registration application, submit a request for drug registration testing to the National Institute for Drug Control or to the drug regulatory authorities of provinces, autonomous regions, or municipalities directly under the central government. If the applicant fails to submit such a request before the acceptance of the drug registration application, the Center for Drug Evaluation shall initiate the drug registration testing within forty days after the acceptance of the drug registration application. In principle, applicants may submit only one request for drug registration testing prior to the acceptance of the drug registration application and shall not simultaneously submit such requests to multiple drug testing institutions.

　　The pharmaceutical registration inspection data submitted by the applicant shall be consistent with the corresponding content in the pharmaceutical registration application materials. During the pharmaceutical registration inspection process, the pharmaceutical inspection agency, samples, and documentation shall not be altered.

　　Article 55: For registration applications for drugs manufactured within China, if the applicant requests drug registration testing prior to acceptance of the registration application, the applicant shall submit a request for sample collection to the drug regulatory authority of the relevant province, autonomous region, or municipality directly under the central government. The drug regulatory authority of the province, autonomous region, or municipality directly under the central government will organize the sample collection and sealing process. The applicant shall then deliver the sampling form, samples, materials required for testing, and reference standards to the corresponding drug testing institution.

　　For registration applications for pharmaceutical products manufactured overseas, if the applicant requests a drug registration inspection prior to the acceptance of the registration application, the applicant shall, in accordance with applicable requirements, collect samples and submit these samples, the materials needed for the inspection, and reference standards to the National Institute for Drug Control.

　　Article 56: For registration applications for drugs manufactured within China, if drug registration testing is required after the application is accepted, the Drug Review Center shall, within forty days of acceptance, issue a notice of drug registration testing to both the drug testing institution and the applicant. The applicant shall submit a request for sample collection to the drug regulatory authorities of the relevant province, autonomous region, or municipality directly under the central government. The drug regulatory authorities of the province, autonomous region, or municipality directly under the central government shall organize the sample collection and seal the samples. Within the prescribed time limit, the applicant shall deliver the sampling form, the samples, the materials required for testing, and reference standards to the corresponding drug testing institution.

　　For registration applications for pharmaceutical products manufactured overseas, if the drug registration application is accepted and requires a drug registration inspection, the applicant shall, in accordance with applicable requirements, collect samples and submit these samples, the materials needed for the inspection, and reference standards to the National Institute for Drug Control.

　　Article 57: The drug testing institution shall, within five days, review the samples and documentation submitted by the applicant and make a decision on whether to accept them, while simultaneously notifying the Drug Review Center. If any corrections are required, the institution shall inform the applicant of all such requirements in one go.

　　In principle, drug testing institutions shall, forty days before the expiration of the review period, submit their standard review opinions and test reports to the Drug Review Center.

　　Article 58: During the review and verification of drug applications, if there are doubts about the authenticity of the submitted documentation, clear leads from reports, or if it is deemed necessary to conduct sample testing, samples may be drawn for analysis.

　　During the review process, the Center for Drug Evaluation may, based on risk considerations, propose a single-item re-examination of quality standards.

　　Chapter 4: Accelerated Drug Registration Procedures for Market Launch

　　Section 1: Breakthrough Therapeutic Drug Program

　　Article 59: During the clinical trial period of a drug, applicants may apply to use the Breakthrough Therapy Designation procedure for innovative drugs or improved new drugs that are intended for the prevention and treatment of serious diseases that pose a life-threatening risk or significantly impair quality of life, and for which there are currently no effective preventive or therapeutic measures available, or for which there is sufficient evidence demonstrating a clear clinical advantage over existing treatment options.

　　Article 60: Applicants seeking to apply the Breakthrough Therapy Drug Program shall submit their application to the Center for Drug Evaluation. If the application meets the relevant criteria, the Center for Drug Evaluation will publicly announce it in accordance with the prescribed procedures and include it in the Breakthrough Therapy Drug Program.

　　Article 61: Clinical trials for drugs included in the Breakthrough Therapy Drug Program shall receive the following policy support:

　　(1) Applicants may submit a request for communication and exchange to the Drug Review Center at critical stages of clinical trials. The Drug Review Center will arrange reviewers to conduct the communication and exchange.

　　(2) The applicant may submit interim research data to the Drug Review Center. Based on the existing research data, the Drug Review Center will provide comments or recommendations on the next-stage research plan and communicate its feedback to the applicant.

　　Article 62: If an applicant finds that a drug included in the Breakthrough Therapy Drug Program no longer meets the eligibility criteria, it shall promptly submit a request to the Center for Drug Evaluation to terminate the Breakthrough Therapy Drug Program. If the Center for Drug Evaluation determines that a drug no longer meets the eligibility criteria, it shall promptly terminate the Breakthrough Therapy Drug Program for that drug and notify the applicant.

　　Section 2: Conditional Approval Procedure

　　Article 63: During the clinical trial period of a drug, a drug that meets any of the following conditions may apply for conditional approval:

　　(1) Medicines for diseases that pose a serious threat to life and for which no effective treatment options currently exist, where clinical trial data have already demonstrated efficacy and can predict their clinical value;

　　(2) Medicines urgently needed in public health, for which clinical trial data already demonstrate efficacy and can predict their clinical value;

　　(3) Vaccines urgently needed to respond to major public health emergencies, or other vaccines identified as urgently needed by the National Health Commission, provided that their benefits have been assessed as outweighing the risks.

　　Article 64: For applications seeking conditional approval, the applicant shall communicate and consult with the Drug Review Center regarding the conditions for conditional approval and the follow-up research work to be conducted after marketing. After such communication and confirmation, the applicant may submit an application for drug marketing authorization.

　　After review and assessment, if a drug meets the requirements for conditional approval, the drug registration certificate shall specify the validity period of the conditionally approved drug registration certificate, as well as the additional research studies that need to be completed after marketing and the corresponding deadlines for completing such studies.

　　Article 65: During the review process, if it is discovered that a drug registration application included in the conditional approval procedure no longer meets the conditions for conditional approval, the Drug Review Center shall terminate the conditional approval procedure for that product and notify the applicant to proceed with the submission and review according to the normal procedures.

　　Article 66: For drugs approved with conditions, the marketing authorization holder shall implement corresponding risk management measures after the drug is launched on the market and, within the prescribed time limit, conduct the required clinical trials and other relevant studies, and submit a supplementary application accordingly.

　　If further research is required when approving a vaccine registration application, the vaccine holder shall complete the research within the prescribed time limit.

　　Article 67: For drugs approved with conditions, if the marketing authorization holder fails to complete the required studies by the deadline or cannot demonstrate that the benefits of the drug outweigh its risks, the National Medical Products Administration shall take legal action accordingly, up to and including revocation of the drug registration certificate.

　　Section 3: Priority Review and Approval Procedures

　　Article 68: When submitting an application for drug marketing authorization, the following drugs with demonstrable clinical value may apply to use the priority review and approval procedure:

　　(1) Innovative drugs and improved new drugs that are urgently needed in clinical practice and are used to prevent and treat major infectious diseases and rare diseases;

　　(2) New varieties, dosage forms, and specifications of pediatric drugs that are compatible with the physiological characteristics of children;

　　(3) Vaccines urgently needed for disease prevention and control, as well as innovative vaccines;

　　(4) Medicines included in the Breakthrough Therapy Drug Program;

　　(5) Medicines that meet the conditions for conditional approval;

　　(6) Other circumstances for priority review and approval as stipulated by the National Medical Products Administration.

　　Article 69: Before submitting an application for drug marketing authorization, the applicant shall communicate and consult with the Drug Review Center. After confirming through such communication and consultation, the applicant shall, at the same time as submitting the drug marketing authorization application, also submit a request for priority review and approval to the Drug Review Center. If the request meets the relevant criteria, the Drug Review Center will, following the prescribed procedures, publicly announce its inclusion in the priority review and approval process.

　　Article 70: For marketing authorization applications for drugs included in the priority review and approval procedure, the following policy support shall be provided:

　　(1) The review period for drug marketing authorization applications is 130 days.

　　(2) For rare disease drugs that are urgently needed clinically and are already marketed overseas but not yet available in China, the review and approval timeframe is 70 days.

　　(3) Priority shall be given to the review, inspection, and approval of generic names of pharmaceutical products that require such procedures.

　　(4) After confirmation through communication and exchange, supplementary technical documentation may be submitted.

　　Article 71: During the review process, if it is discovered that a drug registration application included in the priority review and approval procedure no longer meets the conditions for priority review and approval, the Center for Drug Evaluation shall terminate the priority review and approval procedure for that product, proceed with the review according to the normal review procedures, and notify the applicant accordingly.

Section 4: Special Approval Procedures

　　Article 72: When there is a threat of a public health emergency or after such an emergency has occurred, the National Medical Products Administration may, in accordance with the law, decide to grant special approval for pharmaceutical products needed for the prevention and control of the public health emergency.

　　Article 73: For drug registration applications subject to special approval, the National Medical Products Administration shall, in accordance with the principles of unified command, early involvement, rapid efficiency, and scientific review, organize and expedite the simultaneous conduct of drug registration acceptance, review, verification, and testing. The specific circumstances, procedures, time limits, and requirements for special approval shall be governed by the Regulations on Special Drug Approval Procedures.

　　Article 74: For drugs included in the special approval procedure, their use may be restricted to a specific period and scope based on the particular needs of disease prevention and control.

　　Article 75: If a drug that has been included in the special approval procedure is found to no longer meet the inclusion criteria, the special approval procedure for that drug shall be terminated, and the applicant shall be notified accordingly.

　　Chapter 5: Post-Marketing Changes and Re-registration of Pharmaceuticals

　　Section 1: Post-Marketing Studies and Changes to Pharmaceuticals

　　Article 76: The holder shall proactively conduct post-marketing studies to further confirm the safety, efficacy, and quality controllability of the drug, and strengthen ongoing management of drugs already on the market.

　　If the drug registration certificate and its attachments require the holder to conduct relevant research studies after the drug is launched, the holder shall complete such studies within the prescribed time limit and submit a supplementary application, file a record, or report as required.

　　After a drug is approved for marketing, the marketing authorization holder shall continuously conduct studies on the drug’s safety and efficacy. Based on relevant data, the holder shall promptly file notifications or submit supplemental applications to revise the drug’s labeling, thereby continually updating and improving the labeling and package inserts. The drug regulatory authority, in accordance with its responsibilities, may, based on findings from adverse drug reaction monitoring and post-marketing evaluations, require the marketing authorization holder to revise the labeling and package inserts.

　　Article 77: Post-marketing changes to pharmaceutical products shall be categorized and managed according to the degree of risk and impact they pose on the product’s safety, efficacy, and quality control. These changes are classified into three types: approval-required changes, filing-required changes, and reporting-required changes.

　　The holder shall, in accordance with relevant regulations and referring to applicable technical guidance principles, comprehensively evaluate and verify the impact of the proposed changes on the safety, efficacy, and quality control of the drug, and conduct the corresponding research activities.

　　The technical guidance principles for post-marketing change studies of pharmaceutical products are formulated by the Center for Drug Evaluation and made publicly available.

　　Article 78: The following changes shall be submitted by the holder in the form of a supplementary application and implemented only after approval:

　　(1) Major changes during the pharmaceutical manufacturing process;

　　(2) Changes to the drug’s package insert that involve content related to efficacy as well as other content that increases safety risks;

　　(3) The holder transfers the marketing authorization for the drug;

　　(4) Other changes that are required to be approved by the National Medical Products Administration.

　　Article 79: For the following changes, the holder shall file a record with the drug regulatory authority of the province, autonomous region, or municipality where it is located prior to implementing the change:

　　(1) Moderate changes during the pharmaceutical manufacturing process;

　　(2) Changes to the content of pharmaceutical packaging labels;

　　(3) Repackaging of pharmaceutical products;

　　(4) Other changes that the National Medical Products Administration requires to be filed.

　　If the above-mentioned changes occur in pharmaceutical products manufactured overseas, they shall be reported to the Drug Review Center for record-keeping prior to implementation of the changes.

　　The procedures and requirements for the filing of pharmaceutical dispensing equipment are formulated and released by the Center for Drug Evaluation.

　　Article 80: The holder shall report the following changes in the annual report:

　　(1) Minor changes in the pharmaceutical manufacturing process;

　　(2) Other changes that the National Medical Products Administration requires to be reported.

　　Article 81: Supplementary applications submitted after a drug has been launched shall, if they require verification and testing, follow the procedures for drug registration verification and testing as set forth in these Measures.

　　Section 2: Re-registration of Pharmaceuticals

　　Article 82: The holder shall apply for re-registration six months before the expiration date of the drug registration certificate. For drugs manufactured domestically, the application for re-registration shall be submitted by the holder to the drug regulatory authority of the province, autonomous region, or municipality where the holder is located. For drugs manufactured overseas, the application for re-registration shall be submitted by the holder to the Center for Drug Evaluation.

　　Article 83: After a drug re-registration application is accepted, the drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the central government, or the Drug Review Center, shall review the holder’s performance in conducting post-marketing evaluations and monitoring adverse reactions, the implementation of relevant tasks as required by the drug approval documents and the drug regulatory authorities, and any changes to the information specified in the drug approval documents. If the review finds that the applicant meets the prescribed requirements, the drug shall be re-registered, and a Notice of Approval for Drug Re-registration shall be issued. If the applicant does not meet the prescribed requirements, the drug shall not be re-registered, and the case shall be reported to the National Medical Products Administration for cancellation of the drug registration certificate.

　　Article 84: Re-registration shall not be granted in any of the following circumstances:

　　(1) Those whose validity period has expired and who have not submitted an application for re-registration;

　　(2) During the validity period of the drug registration certificate, the holder fails to fulfill its responsibility to continuously monitor the drug’s quality, efficacy, and adverse reactions;

　　(3) Failure to complete the drug approval documentation and the research work required by the drug regulatory authority within the prescribed time limit without a valid reason;

　　(4) After post-marketing evaluation, those found to have uncertain efficacy, significant adverse reactions, or posing risks to human health for other reasons;

　　(5) Other circumstances stipulated by laws and administrative regulations that do not permit re-registration.

　　For drugs that are not re-registered, the drug registration certificate shall be canceled upon expiration of its validity period.

　　Chapter 6: Filing, Withdrawal of Applications, Approval Decisions, and Dispute Resolution

　　Article 85: After receiving a drug registration application, the drug regulatory authority shall conduct a formal review and, depending on the following circumstances, make a decision as to whether to accept the application:

　　(1) If the application does not legally require administrative licensing, a decision of non-acceptance shall be made immediately, along with an explanation of the reasons.

　　(2) 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.

　　(3) If the submitted materials contain errors that can be corrected on the spot, the applicant should be allowed to make the corrections on the spot. Once the corrected materials are complete and conform to the legally prescribed format, they shall be accepted.

　　(4) If the application materials are incomplete or do not conform to the legally prescribed format, the applicant shall be notified on the spot or within five days of all the items that need to be corrected in one go. If the regulations require that the application materials be returned together with the notification, such materials shall be returned accordingly. The applicant shall complete the correction of the materials within thirty days. If the applicant fails to make the necessary corrections within the deadline without justifiable reasons, it shall be deemed that the applicant has waived the application, and no decision of non-acceptance need be made. If the applicant is not notified of the need to correct the materials within the prescribed time limit, the application shall be deemed accepted as of the date on which the application materials were received.

　　(5) If the application falls within the purview of this department, the submitted documentation is complete and conforms to the legally prescribed format, or if the applicant submits all supplementary materials as required, the drug registration application shall be accepted.

　　After a drug registration application is accepted, if the applicant is required to pay fees, the applicant shall pay the fees as prescribed. If the applicant fails to pay the fees within the prescribed time limit, the review and approval process for the drug registration will be terminated.

　　Article 86: After a drug registration application is accepted, if new findings regarding the drug’s safety are discovered, the applicant shall promptly report such findings and supplement the relevant documentation.

　　Article 87: After a drug registration application is accepted, if the applicant is required to supplement the original submission with new technical data, the Drug Review Center shall, in principle, issue a single request for supplementary information, clearly listing all outstanding issues and notifying the applicant in writing to submit the supplementary materials within eighty days. The applicant shall submit all requested supplementary materials in one go; the time taken to provide such supplementary materials shall not be counted toward the drug review period. Upon receipt of all supplementary materials submitted by the applicant, the Drug Review Center shall commence the review process, extending the review period by one-third. If the priority review and approval procedure applies, the review period shall be extended by one-quarter.

　　If the applicant is not required to submit new technical data but only needs to provide explanations and clarifications regarding the original submitted materials, the Center for Drug Evaluation will notify the applicant to submit the relevant explanations and clarifications within five days as required.

　　If the Drug Review Center determines that there are substantial defects that cannot be corrected, it will no longer require the applicant to submit additional information. A decision of non-approval will be made based on the existing submitted materials.

　　Article 88: During the review period for an application for clinical trials of a drug or for a supplemental application submitted during the course of such clinical trials, no new technical data may be added. If new studies need to be conducted, the applicant may withdraw the current application and then re-submit it.

　　Article 89: After a drug registration application has been accepted, the applicant may withdraw the application. If the withdrawal is approved, the Drug Review Center or the drug regulatory authority of the province, autonomous region, or municipality directly under the central government shall terminate the registration procedure and notify the technical institutions responsible for drug registration verification, testing, and other related activities. Should any illegal acts—such as concealing true facts or providing false information—be discovered during the review, verification, or testing process, they shall be dealt with in accordance with the law; in such cases, the applicant shall not be permitted to withdraw the drug registration application.

　　Article 90: During the drug registration period, if the review conclusion is that the application is not approved, the Drug Review Center shall inform the applicant of the reasons for the rejection. The applicant may file an objection with the Drug Review Center within fifteen days. The Drug Review Center will conduct a comprehensive assessment based on the applicant’s objections and provide feedback to the applicant.

　　If the applicant still has objections to the comprehensive assessment results, the Drug Review Center shall, in accordance with the relevant regulations, organize an expert advisory committee to conduct a review within fifty days and, based on the combined findings of the expert review, reach a final review conclusion.

　　The time for applicant objections and expert reviews is not included in the review period.

　　Article 91: During the drug registration process, if the applicant believes that staff members have violated regulations or engaged in improper conduct in any of the following activities—drug registration acceptance, review, verification, testing, or approval—the applicant may file a complaint or report to the applicant’s own organization or to its superior authority.

　　Article 92: A drug registration application that meets the statutory requirements shall be approved.

　　The drug registration application shall not be approved if any of the following circumstances exist:

　　(1) The research data submitted with the application for a clinical trial of a drug are insufficient to support the conduct of the clinical trial or cannot ensure the safety of the subjects;

　　(2) The application materials indicate that the applicant’s drug has significant deficiencies in terms of safety, efficacy, and controllability of quality;

　　(3) The submitted documentation fails to demonstrate the safety, efficacy, and controllability of quality of the drug, or the drug is assessed as having risks that outweigh its benefits.

　　(4) The applicant failed to supplement the required materials within the prescribed time limit;

　　(5) The applicant refuses to undergo or fails, without justifiable reason, to undergo the drug registration verification and inspection within the prescribed time limit;

　　(6) During the drug registration process, if the submitted documentation is deemed to be untrue and the applicant cannot provide evidence to substantiate its authenticity;

　　(7) The on-site verification of drug registration or the results of sample testing do not meet the prescribed requirements;

　　(8) Other circumstances that, according to laws and regulations, should not be approved.

　　Article 93: After the approval of a drug registration application is completed, if the applicant disagrees with the administrative licensing decision, they may, in accordance with the law, file an administrative reconsideration or an administrative lawsuit.

　　Chapter 7: Work Time Limit

　　Article 94: The time limits stipulated in these Measures represent the maximum durations for the acceptance, review, verification, testing, and approval of drug registration. For time limits related to the priority review and approval procedures, the relevant provisions on priority review and approval shall apply.

　　Technical institutions such as the Drug Review Center shall clearly define their internal work procedures and timelines and make them publicly available.

　　Article 95: After receiving a drug registration application, the drug regulatory authority shall conduct a formal review and, within five days, make a decision to accept the application, request supplementary materials, or reject the application.

　　Article 96: The time limits for drug registration review shall be implemented in accordance with the following provisions:

　　(1) The review and approval timeframe for applications for clinical trials of drugs and supplementary applications submitted during the course of drug clinical trials is sixty days.

　　(2) The review and approval period for drug marketing authorization applications is 200 days. Among these, the review and approval period for priority review and approval procedures is 130 days, while the review and approval period for priority review and approval procedures for urgently needed rare disease drugs already marketed abroad is 70 days.

　　(3) The review and approval timeframe for the individual submission of generic chemical APIs already marketed in China is 200 days.

　　(4) The review period for supplementary applications involving approval-based changes is 60 days. If the supplementary application involves the combined submission of multiple items, the review period will be 80 days. Among these, the review period for those involving the examination of clinical trial data and drug registration verification and inspection shall be 200 days.

　　(5) The approval period for generic drug names is 30 days;

　　(6) The review period for the appropriateness of over-the-counter drugs is 30 days.

　　The review timeframe for the associated assessment is consistent with the review timeframe for the associated pharmaceutical formulation.

　　Article 97: The time limit for drug registration inspections shall be governed by the following provisions:

　　(1) The Drug Review Center shall, within 40 days after accepting a drug registration application, notify the Drug Inspection Center to initiate an inspection and simultaneously notify the applicant.

　　(2) In principle, the Drug Verification Center shall complete on-site verification of drug registration and manufacturing facilities no later than 40 days before the expiration of the review period, and shall promptly submit relevant materials, including verification findings and results, to the Drug Review Center.

　　Article 98: The time limit for drug registration testing shall be governed by the following provisions:

　　(1) The time limit for sample testing is 60 days; if sample testing and standard review are conducted concurrently, the time limit is 90 days.

　　(2) The deadline for submitting supplementary materials during the drug registration inspection process is 30 days.

　　(3) In principle, drug testing institutions shall complete the relevant work for drug registration testing no later than 40 days before the expiration of the review period, and shall submit their opinions on the re-examination of drug standards and the test reports to the Drug Review Center.

　　Article 99: The review and approval period for the re-registration of pharmaceutical products shall be 120 days.

　　Article 100: The administrative approval decision shall be made within twenty days.

　　Article 101: The drug regulatory authority shall issue and deliver the relevant administrative license documents within ten days from the date on which it makes the decision on drug registration approval.

　　Article 102: If special circumstances arise due to the characteristics of the product or because of review, verification, inspection, and other related work that necessitate an extension of the time limit, the extended period shall not exceed one-half of the original time limit. After obtaining approval from the heads of the relevant technical institutions responsible for drug review, verification, and inspection, the technical institution extending the time limit shall notify the applicant in writing and also inform other relevant technical institutions.

　　Article 103: The following periods shall not be counted toward the relevant work deadlines:

　　(1) The time required for the applicant to supplement materials, carry out verification and rectification, and verify, as required, the production process, quality standards, and instructions, etc.;

　　(2) Delays in verification, inspection, or convening expert consultation meetings due to reasons attributable to the applicant;

　　(3) The time occupied during the suspension of the review and approval procedures as prescribed by laws and regulations;

　　(4) The time spent on overseas verification when initiating overseas verification.

　　Chapter 8: Supervision and Management

　　Article 104: The National Medical Products Administration is responsible for the supervision, assessment, evaluation, and guidance of the Drug Review Center and other relevant specialized technical institutions, as well as the drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the central government, in their work related to drug registration management.

　　Article 105: The drug regulatory authorities shall conduct supervision and inspection of drug research and development activities in accordance with the provisions of laws and regulations. When necessary, they may extend their inspections to entities and individuals that provide products or services for drug research and development. Such entities and individuals shall cooperate fully and shall not refuse or conceal any information.

　　Article 106: The Information Center is responsible for establishing drug profile files and implementing coding management for pharmaceutical products. It shall collect information on drug registration applications, safety-related reports generated during clinical trials, review and assessment activities, inspections, testing, approval processes, as well as post-marketing changes that require approval, filing, or reporting, and shall continuously update such information. The relevant systems for drug profile files and coding management shall be formulated and promulgated by the Information Center.

　　Article 107: The drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the central government shall organize routine supervision and inspection of drug non-clinical safety evaluation research institutions, drug clinical trial institutions, and other such entities within their jurisdictions to ensure compliance with the Good Laboratory Practice for Non-Clinical Studies and the Good Clinical Practice for Clinical Trials, and to continuously monitor their ongoing adherence to statutory requirements. The National Medical Products Administration shall, as needed, conduct supervision and inspection of drug non-clinical safety evaluation research institutions, drug clinical trial institutions, and other similar research organizations.

　　Article 108: The National Medical Products Administration shall establish a credit management system for pharmaceutical safety. The Drug Inspection Center shall be responsible for setting up pharmaceutical safety credit files for non-clinical safety evaluation research institutions and clinical trial institutions, recording information such as license issuance, results of routine supervision and inspection, and handling of illegal activities. Such records shall be publicly disclosed to the public in accordance with the law and updated promptly. Pharmaceutical regulatory authorities shall increase the frequency of supervision and inspection for entities with adverse credit records and may impose joint punitive measures in accordance with national regulations. The specific systems governing the pharmaceutical safety credit files of non-clinical safety evaluation research institutions and clinical trial institutions shall be formulated and promulgated by the Drug Inspection Center.

　　Article 109: The National Medical Products Administration shall, in accordance with the law, publicly disclose to the public a list of drug registration and approval items, along with their legal basis, approval requirements, and processing deadlines. It shall also make public to applicants the progress of drug registration and, to the general public, the review conclusions and supporting evidence for drugs approved for market launch, as well as any illegal or non-compliant activities identified during supervision and inspection, thereby accepting public oversight.

　　The package inserts for drugs approved for market release shall be made publicly available and updated promptly. In particular, vaccine labels shall also be made publicly available and updated in a timely manner.

　　Without the applicant’s consent, the drug regulatory authorities, specialized technical institutions and their staff, as well as personnel involved in expert reviews, shall not disclose any trade secrets, undisclosed information, or confidential business information submitted by the applicant, except as otherwise provided by law or where such disclosure is necessary for national security or involves significant public interests.

　　Article 110: If any of the following circumstances apply, the National Medical Products Administration shall revoke the drug registration certificate and make the revocation public:

　　(1) The holder voluntarily requests the cancellation of the drug registration certificate;

　　(2) Those that are not to be re-registered in accordance with the provisions of these Measures;

　　(3) The holder’s drug registration certificate, drug production license, or other administrative permits have been lawfully revoked or canceled;

　　(4) In accordance with Article 83 of the Drug Administration Law, drugs whose efficacy is uncertain, have significant adverse reactions, or pose a risk to human health for other reasons;

　　(5) In accordance with Article 61 of the Vaccine Administration Law, if post-marketing evaluation reveals that a vaccination adverse reaction is serious or otherwise poses a risk to human health;

　　(6) In accordance with Article 62 of the Vaccine Administration Law, if post-marketing evaluation reveals that the product design, manufacturing process, safety, efficacy, or quality controllability of a particular vaccine variety is significantly inferior to those of other vaccine varieties used for the prevention and control of the same disease;

　　(7) Violating the provisions of laws and administrative regulations by failing to complete the corresponding research work within the prescribed time limit as required by the drug approval documents or the requirements of the drug regulatory authorities, without providing a reasonable justification;

　　(8) Other circumstances in which the drug registration certificate shall be revoked according to law.

　　Chapter Nine: Legal Liability

　　Article 111: In the drug registration process, anyone who provides false certificates, data, materials, samples, or employs other deceptive means to obtain clinical trial approval or other drug registration approvals shall be dealt with in accordance with Article 123 of the Drug Administration Law.

　　Article 112: Any applicant who provides false data, materials, or samples for the clinical trials or registration of vaccines, or engages in other deceptive practices, shall be dealt with in accordance with Article 81 of the Vaccine Administration Law.

　　Article 113: During the drug registration process, if institutions engaged in non-clinical safety evaluation studies and clinical trial institutions fail to comply with the Good Laboratory Practice for Non-Clinical Studies and the Good Clinical Practice for Clinical Trials as required, they shall be dealt with in accordance with Article 126 of the Drug Administration Law.

　　Article 114: Any clinical trials of drugs conducted without approval shall be handled in accordance with Article 125 of the Drug Administration Law; any bioequivalence studies conducted without prior filing shall be handled in accordance with Article 127 of the Drug Administration Law.

　　Article 115: During a clinical trial of a drug, if safety issues or other risks are discovered and the sponsor fails to promptly adjust the clinical trial protocol, suspend or terminate the clinical trial, or fail to report such issues to the National Medical Products Administration, the matter shall be handled in accordance with Article 127 of the Drug Administration Law.

　　Article 116: In violation of the provisions of Article 28 and Article 33 of these Measures, if the applicant falls into any of the following circumstances, it shall be ordered to make corrections within a specified time limit; failure to make corrections within the time limit shall result in a fine of between 10,000 and 30,000 yuan:

　　(1) Failing to register as required on the Drug Clinical Trial Registration and Information Disclosure Platform before conducting a drug clinical trial;

　　(2) Failure to submit the safety update report for the R&D period as required;

　　(3) Failure to register information such as clinical trial results after the completion of a drug clinical trial.

　　Article 117: If a pharmaceutical inspection agency issues false inspection reports when undertaking inspection work required for drug registration, it shall be handled in accordance with Article 138 of the Drug Administration Law.

　　Article 118: Any approval of clinical trials for drugs that do not meet the required conditions, or the issuance of drug registration certificates for drugs that do not meet the requirements, shall be handled in accordance with Article 147 of the Drug Administration Law.

　　Article 119: If the drug regulatory authority and its staff engage in illegal or non-compliant activities during the drug registration management process, they shall be dealt with in accordance with relevant laws and regulations.

　　Chapter Ten: Supplementary Provisions

　　Article 120: For registration applications of drugs subject to other special regulatory provisions—such as narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, and drug-related precursors—apart from complying with the provisions of these Measures, applicants must also meet other relevant national regulations.

　　Article 121: The standards for exported vaccines shall comply with the standards of the importing country (or region) or the requirements stipulated in the contract.

　　Article 122: For combination products of pharmaceuticals and medical devices that are proposed for registration, if a similar product has already been classified as a pharmaceutical based on its attributes, the application shall be submitted as a pharmaceutical. If the product’s classification has not yet been determined, the applicant shall apply to the National Medical Products Administration for a determination of the product’s classification prior to submitting the registration application. If the classification is primarily as a pharmaceutical, the registration shall proceed according to the procedures specified in these Measures; among them, the research data pertaining to the medical device portion shall be reviewed and concluded by the Medical Device Technical Review Center of the National Medical Products Administration before being forwarded to the Pharmaceutical Review Center for comprehensive review.

　　Article 123: The approval code format for domestically produced pharmaceuticals is as follows: National Drug Approval Number H (Z, S) + four-digit year code + four-digit sequential number. The approval code format for pharmaceuticals produced in the Hong Kong, Macao, and Taiwan regions of China is as follows: National Drug Approval Number H (Z, S) C + four-digit year code + four-digit sequential number.

　　The approval code for pharmaceutical products manufactured overseas is formatted as follows: National Drug Approval Code H (Z, S) J + four-digit year code + four-digit sequential number.

　　Among these, H stands for chemical drugs, Z stands for traditional Chinese medicine, and S stands for biological products.

　　The drug approval number remains unchanged even if there are subsequent changes to the registration details after the product is launched.

　　For Chinese medicinal products with special provisions, those provisions shall prevail.

　　Article 124: The electronic documents of drug registration approval certificates and active pharmaceutical ingredient approval documents produced by the drug regulatory authorities shall have the same legal effect as their paper counterparts.

　　Article 125: The time periods stipulated in these Measures shall be calculated in working days.

　　Article 126: These Measures shall take effect as of July 1, 2020. The “Measures for the Administration of Drug Registration,” promulgated by Order No. 28 of the former State Food and Drug Administration on July 10, 2007, shall be repealed concurrently.