Drug Administration Law of the People's Republic of China

　　Release date: 2019-08-27

　　(Adopted at the 7th Meeting of the Standing Committee of the 6th National People’s Congress on September 20, 1984; first revised at the 20th Meeting of the Standing Committee of the 9th National People’s Congress on February 28, 2001)

　　First amended pursuant to the “Decision on Amending Seven Laws, Including the Law of the People’s Republic of China on Marine Environmental Protection,” adopted at the Sixth Session of the Standing Committee of the 12th National People’s Congress on December 28, 2013.

　　Second Amendment pursuant to the “Decision on Amending the Drug Administration Law of the People’s Republic of China,” adopted at the 14th Session of the Standing Committee of the 12th National People’s Congress on April 24, 2015.

　　Second Amendment adopted at the 12th Session of the Standing Committee of the 13th National People's Congress on August 26, 2019

　　eye Record

　　Chapter One General then

　　Chapter 2: Drug Development and Registration

　　Chapter 3: Marketing Authorization Holder of Pharmaceuticals

　　Chapter Four: Pharmaceutical Production

　　Chapter 5: Pharmaceutical Distribution

　　Chapter Six: Pharmaceutical Management in Medical Institutions

　　Chapter 7: Post-Marketing Drug Management

　　Chapter 8: Drug Prices and Advertising

　　Chapter 9: Pharmaceutical Reserves and Supply

　　Chapter Ten: Supervision and Management

　　Chapter Eleven: Legal Liability

　　Chapter 12: Appendices then

　　Chapter One General then

　　Article 1: This Law is enacted to strengthen pharmaceutical management, ensure drug quality, safeguard public safety and legitimate rights and interests in the use of drugs, and protect and promote public health.

　　Article 2: This Law applies to activities related to the research and development, production, distribution, use, and regulatory oversight of pharmaceutical products conducted within the territory of the People’s Republic of China.

　　The term “medicinal products” as used in this Law refers to substances intended for the prevention, treatment, or diagnosis of human diseases, designed to purposefully regulate human physiological functions, and characterized by specified indications or primary therapeutic effects, as well as defined dosage and administration methods. Such substances include traditional Chinese medicines, chemical drugs, biological products, and others.

　　Article 3: Drug management shall be centered on people’s health, adhere to the principles of risk management, full-process control, and joint governance by society, establish a scientific and stringent supervision and management system, comprehensively enhance drug quality, and ensure that drugs are safe, effective, and accessible.

　　Article 4: The State shall develop both modern and traditional medicines and fully harness their roles in prevention, medical treatment, and health care.

　　The state protects wild medicinal herb resources and traditional Chinese medicine varieties, and encourages the cultivation of authentic Chinese medicinal materials.

　　Article 5: The State encourages the research and development of new drugs and protects the legitimate rights and interests of citizens, legal entities, and other organizations in their research and development of new drugs.

　　Article 6: The State implements a marketing authorization holder system for pharmaceuticals. The marketing authorization holder is legally responsible for the safety, efficacy, and quality control of pharmaceuticals throughout the entire process—from research and development, to manufacturing, distribution, and use.

　　Article 7: Any entity engaged in the research and development, production, distribution, or use of pharmaceutical products shall comply with laws, regulations, rules, standards, and guidelines, and ensure that information throughout the entire process is authentic, accurate, complete, and traceable.

　　Article 8: The drug regulatory authority under the State Council is responsible for nationwide drug regulatory oversight. Relevant departments of the State Council shall, within their respective areas of responsibility, be in charge of regulatory oversight related to drugs. The drug regulatory authority under the State Council shall, in coordination with the relevant departments of the State Council, implement the national development plan and industrial policies for the pharmaceutical industry.

　　The drug supervision and administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the central government are responsible for drug supervision and administration within their respective administrative areas. The departments of the people's governments at or above the county level that assume drug supervision and administration responsibilities (hereinafter referred to as "drug supervision and administration departments") are responsible for drug supervision and administration within their respective administrative areas. Relevant departments of local people's governments at or above the county level are responsible for supervision and administration related to drugs within the scope of their respective duties.

　　Article 9: Local people's governments at or above the county level shall be responsible for pharmaceutical supervision and management within their administrative areas. They shall provide unified leadership, organization, and coordination of pharmaceutical supervision and management activities as well as emergency response efforts for pharmaceutical safety incidents within their administrative areas, and establish and improve mechanisms for pharmaceutical supervision and management and information-sharing.

　　Article 10: People's governments at or above the county level shall incorporate drug safety work into their respective national economic and social development plans, include funding for drug safety work in their respective government budgets, strengthen capacity-building in drug supervision and management, and provide adequate support for drug safety efforts.

　　Article 11: Pharmaceutical professional and technical institutions established or designated by the drug regulatory authorities shall undertake tasks such as review, inspection, verification, monitoring, and evaluation required for the lawful implementation of drug supervision and management.

　　Article 12: The State shall establish and improve a drug traceability system. The drug supervision and administration department under the State Council shall formulate unified standards and regulations for drug traceability, promote the interoperability and sharing of drug traceability information, and ensure that drugs are fully traceable.

　　The state has established a pharmacovigilance system to monitor, identify, evaluate, and control adverse drug reactions and other harmful reactions related to medication use.

　　Article 13: People's governments at all levels and their relevant departments, as well as pharmaceutical industry associations, shall strengthen publicity and education on drug safety and carry out popularization efforts regarding knowledge of drug safety laws and regulations.

　　News media should carry out public awareness campaigns on knowledge related to drug safety laws and regulations, and exercise public oversight over illegal activities involving pharmaceutical products. Publicity and reporting on pharmaceutical products should be comprehensive, scientific, objective, and impartial.

　　Article 14: Pharmaceutical industry associations shall strengthen self-discipline within the industry, establish and improve industry standards, promote the development of an industry integrity system, and guide and urge their members to carry out pharmaceutical production and business activities in compliance with the law.

　　Article 15: The people's governments above the county level and their relevant departments shall, in accordance with national regulations, commend and reward units and individuals that have made outstanding contributions to the research and development, production, distribution, use, and supervisory management of pharmaceuticals.

　　Chapter 2: Drug Development and Registration

　　Article 16: The State supports drug innovation that is clinically oriented and demonstrates clear or specific therapeutic effects on human diseases. It encourages the development of new drugs with novel mechanisms of action, capable of treating serious life-threatening illnesses or rare diseases, and possessing multi-target systemic regulatory and intervention functions on the human body, thereby promoting technological advancement in pharmaceuticals.

　　The state encourages the use of modern scientific and technological methods as well as traditional Chinese medicine research approaches to conduct scientific and technological research and drug development in the field of Chinese medicine, establish and improve a technical evaluation system that is tailored to the characteristics of Chinese medicine, and promote the inheritance and innovation of Chinese medicine.

　　The state has adopted effective measures to encourage the research and innovation of pediatric drugs, supporting the development of new varieties, dosage forms, and specifications of pediatric drugs that are tailored to children’s physiological characteristics. Pediatric drugs will be given priority review and approval.

　　Article 17: Any entity engaged in pharmaceutical research and development shall comply with the Good Laboratory Practice for Non-Clinical Studies and the Good Clinical Practice for Clinical Trials, ensuring that the entire pharmaceutical research and development process continuously meets statutory requirements.

　　The Good Practice for Non-clinical Research of Drugs and the Good Clinical Practice for Drug Clinical Trials are formulated by the drug regulatory authority under the State Council in conjunction with relevant departments under the State Council.

　　Article 18: The conduct of non-clinical drug studies shall comply with relevant national regulations and shall be supported by personnel, facilities, equipment, instruments, and management systems that are appropriate for the research project, thereby ensuring the authenticity of the associated data, materials, and samples.

　　Article 19: To conduct clinical trials of drugs, it is necessary to truthfully submit relevant data, materials, and samples—including the development methods, quality specifications, pharmacological and toxicological test results—as prescribed by the drug regulatory authority under the State Council, and obtain approval from that authority. The drug regulatory authority under the State Council shall, within sixty working days from the date of receipt of the clinical trial application, decide whether to approve the application and notify the applicant; failure to notify within the specified period shall be deemed as approval. In particular, for bioequivalence studies, a record must be filed with the drug regulatory authority under the State Council.

　　Clinical trials of drugs shall be conducted at clinical trial institutions that meet the relevant requirements. Clinical trial institutions for drugs shall be subject to a filing management system, and the specific measures shall be jointly formulated by the drug regulatory authority under the State Council and the health authority under the State Council.

　　Article 20: The conduct of clinical trials involving drugs shall comply with ethical principles and require the development of a clinical trial protocol that has been reviewed and approved by an ethics committee.

　　The Ethics Committee shall establish a system for ethical review to ensure that the ethical review process is independent, objective, and fair; supervise the standardized conduct of clinical trials of drugs; safeguard the legitimate rights and interests of subjects; and protect the public interest.

　　Article 21: When conducting clinical trials of drugs, researchers shall truthfully inform and explain to the subjects or their guardians the detailed information about the purpose and risks of the clinical trial, obtain a voluntarily signed informed consent form from the subjects or their guardians, and take effective measures to protect the legitimate rights and interests of the subjects.

　　Article 22: During a clinical trial of a drug, if safety issues or other risks are identified, the sponsor of the clinical trial shall promptly adjust the clinical trial protocol, suspend or terminate the clinical trial, and report to the Drug Administration Department of the State Council. If necessary, the Drug Administration Department of the State Council may order the sponsor to adjust the clinical trial protocol, suspend or terminate the clinical trial.

　　Article 23: For drugs currently undergoing clinical trials for the treatment of serious, life-threatening diseases for which no effective treatment options yet exist, if medical observation suggests potential benefits and the use complies with ethical principles, such drugs may, after review and informed consent, be used within the institution conducting the clinical trial for other patients with the same condition.

　　Article 24: Drugs marketed in China shall be approved by the drug regulatory authority under the State Council and obtain a drug registration certificate; however, this does not apply to Chinese medicinal materials and processed Chinese medicinal pieces that are not subject to approval management. The catalog of Chinese medicinal materials and processed Chinese medicinal pieces subject to approval management shall be formulated jointly by the drug regulatory authority under the State Council and the competent authority for traditional Chinese medicine under the State Council.

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

　　Article 25: For pharmaceutical products applying for registration, the drug regulatory authority under the State Council shall organize pharmacists, medical professionals, and other technical personnel to conduct an evaluation. This evaluation shall cover the safety, efficacy, and controllability of quality of the pharmaceutical product, as well as the applicant’s capabilities in quality management, risk prevention and control, and liability compensation. If the application meets the requirements, the drug registration certificate shall be issued.

　　When reviewing and approving pharmaceutical products, the drug regulatory authority under the State Council conducts a comprehensive review and approval of both the chemical active pharmaceutical ingredients and related excipients, packaging materials, and containers that come into direct contact with the drugs. It also approves the quality standards, manufacturing processes, labels, and package inserts for these pharmaceutical products in a unified manner.

　　The excipients referred to in this Law are the fillers and additives used in the manufacture of pharmaceuticals and in compounding prescriptions.

　　Article 26: For drugs used to treat diseases that pose a serious threat to life and for which no effective treatment currently exists, as well as for pharmaceuticals urgently needed in public health, if clinical trial data already demonstrate efficacy and allow prediction of their clinical value, conditional approval may be granted, and the relevant details shall be specified in the drug registration certificate.

　　Article 27: The drug regulatory authority under the State Council shall improve the system for drug review and approval, strengthen capacity-building, establish and refine mechanisms such as communication and exchange platforms and expert consultation systems, optimize the review and approval processes, and enhance the efficiency of review and approval.

　　The review conclusions and supporting evidence for drugs approved for market launch shall be made publicly available in accordance with the law and shall be subject to public oversight. Commercial secrets learned during the review and approval process shall be kept confidential.

　　Article 28: Medicines shall conform to the national pharmaceutical standards. If the pharmaceutical quality standards approved by the drug regulatory authority under the State Council are higher than the national pharmaceutical standards, the approved pharmaceutical quality standards shall prevail; if there are no national pharmaceutical standards, the approved pharmaceutical quality standards shall apply.

　　The “Pharmacopoeia of the People’s Republic of China” and drug standards promulgated by the drug regulatory authority under the State Council constitute the national drug standards.

　　The drug regulatory authority under the State Council, together with the health authority under the State Council, shall establish a Pharmacopoeia Committee responsible for the formulation and revision of national pharmaceutical standards.

　　The drug inspection institutions established or designated by the drug regulatory authority under the State Council are responsible for calibrating national reference standards and control substances for drugs.

　　Article 29: The names of pharmaceutical products included in the National Pharmacopoeia shall be their generic names. Any name already established as a generic name for a pharmaceutical product may not be used as a pharmaceutical trademark.

Chapter 3: Marketing Authorization Holder of Pharmaceuticals

　　Article 30: The marketing authorization holder of a drug refers to an enterprise that has obtained the drug registration certificate or a drug research and development institution, among others.

　　The marketing authorization holder of a pharmaceutical product shall, in accordance with the provisions of this Law, bear responsibility for non-clinical studies, clinical trials, manufacturing and marketing, post-marketing studies, monitoring and reporting of adverse reactions, and their handling. Other entities and individuals engaged in activities such as pharmaceutical research and development, manufacturing, marketing, storage, transportation, and use shall assume their corresponding responsibilities according to law.

　　The legal representative and principal person in charge of the marketing authorization holder are fully responsible for the quality of the drug.

　　Article 31: The marketing authorization holder of a pharmaceutical product shall establish a pharmaceutical quality assurance system and assign dedicated personnel to independently take charge of pharmaceutical quality management.

　　The marketing authorization holder of a pharmaceutical product shall conduct regular audits of the quality management systems of contracted pharmaceutical manufacturers and pharmaceutical distributors, and shall supervise their ongoing ability to ensure and control quality.

　　Article 32: The marketing authorization holder of a drug may either manufacture the drug themselves or entrust a pharmaceutical manufacturer to produce it.

　　If the marketing authorization holder of a drug produces the drug itself, it shall obtain a drug production license in accordance with the provisions of this Law. If it entrusts another party to produce the drug, it shall entrust a qualified drug manufacturer. The marketing authorization holder and the contract manufacturing enterprise shall sign a contract for entrustment and a quality agreement, and shall strictly fulfill the obligations stipulated in these agreements.

　　The drug regulatory authority under the State Council has formulated guidelines for quality agreements on commissioned drug manufacturing, providing guidance and oversight to help marketing authorization holders and contracted manufacturing enterprises fulfill their obligations to ensure drug quality.

　　Blood products, anesthetic drugs, psychotropic drugs, toxic drugs for medical use, and drug-related precursors that are easily used to manufacture illicit drugs may not be entrusted for production; however, this does not apply if otherwise provided by the drug regulatory authority under the State Council.

　　Article 33: The marketing authorization holder of a pharmaceutical product shall establish a drug release procedure. It shall review the drugs released by the pharmaceutical manufacturer before they are allowed to leave the factory; only after being signed off by the person authorized for quality may the drugs be released. Drugs that do not meet national pharmaceutical standards shall not be released.

　　Article 34: The marketing authorization holder of a drug may either sell the drug for which it has obtained a drug registration certificate directly, or entrust its sale to a pharmaceutical distribution enterprise. If the marketing authorization holder engages in retail activities involving drugs, it shall obtain a pharmaceutical distribution license.

　　If the marketing authorization holder of a drug sells the drug directly, it shall meet the conditions stipulated in Article 52 of this Law. If it entrusts another party with the sale, it shall entrust such sale to a pharmaceutical enterprise that meets the relevant requirements. The marketing authorization holder and the entrusted operator shall sign a consignment agreement and strictly fulfill the obligations set forth in the agreement.

　　Article 35: When the marketing authorization holder of a drug, the drug manufacturer, or the drug distribution enterprise entrusts another party with the storage and transportation of drugs, they shall assess the entrusted party’s capability in quality assurance and risk management, sign a consignment agreement with the party, specifying such matters as drug quality responsibilities and operating procedures, and exercise supervision over the entrusted party.

　　Article 36: Holders of drug marketing authorization, pharmaceutical manufacturers, pharmaceutical distributors, and medical institutions shall establish and implement a drug traceability system, provide traceability information as required, and ensure that drugs are traceable.

　　Article 37: The marketing authorization holder of a drug shall establish an annual reporting system and, each year, submit to the drug regulatory authorities of the provincial, autonomous region, or municipality governments a report on the drug’s production and sales, post-marketing studies, risk management, and other relevant matters as required.

　　Article 38: If the marketing authorization holder of a pharmaceutical product is an overseas entity, the corporate legal person designated by it within China shall fulfill the obligations of the marketing authorization holder and bear joint and several liability together with the marketing authorization holder.

　　Article 39: Manufacturers of traditional Chinese medicine granules shall fulfill the relevant obligations of the marketing authorization holder, implement full-process management over the production and sale of these granules, establish a traceability system for traditional Chinese medicine granules, and ensure that these granules are safe, effective, and traceable.

　　Article 40: With the approval of the drug regulatory authority under the State Council, the marketing authorization holder may transfer the drug marketing authorization. The transferee shall possess the capabilities necessary to ensure the safety, efficacy, and controllable quality of the drug, including robust quality management, risk prevention and control, and liability compensation, and shall fulfill the obligations of the marketing authorization holder.

Chapter Four: Pharmaceutical Production

　　Article 41: To engage in pharmaceutical production activities, one must obtain a pharmaceutical production license approved by the drug regulatory authority of the people's government of the province, autonomous region, or municipality directly under the central government where the enterprise is located. No entity may produce pharmaceuticals without a valid pharmaceutical production license.

　　A drug production license shall indicate its validity period and the scope of production, and shall be re-examined and reissued upon expiration.

　　Article 42: To engage in pharmaceutical production activities, the following conditions must be met:

　　(1) There are pharmacy technicians, engineering technicians, and corresponding skilled workers who have been legally qualified and certified;

　　(2) Possess facilities, equipment, and sanitary conditions that are suitable for pharmaceutical production;

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

　　(4) There shall be regulations and systems in place to ensure drug quality, and these shall comply with the Good Manufacturing Practice requirements for pharmaceutical products as formulated by the drug regulatory authority under the State Council pursuant to this Law.

　　Article 43: Those engaged in pharmaceutical production activities shall comply with the Good Manufacturing Practice for Pharmaceuticals, establish and improve a pharmaceutical production quality management system, and ensure that the entire pharmaceutical production process continuously meets statutory requirements.

　　The legal representative and the principal person in charge of a pharmaceutical manufacturer shall bear full responsibility for the pharmaceutical production activities of their enterprise.

　　Article 44: Medicines shall be manufactured in accordance with national pharmaceutical standards and the manufacturing processes approved by the drug regulatory authorities. Production and inspection records shall be complete and accurate, and no falsification is permitted.

　　Chinese medicinal herbs in decoction form shall be processed in accordance with the national pharmaceutical standards. If the national pharmaceutical standards do not specify processing procedures, they shall be processed according to the processing specifications formulated by the drug regulatory authorities of the people's governments of provinces, autonomous regions, and municipalities directly under the central government. The processing specifications formulated by the drug regulatory authorities of the people's governments of provinces, autonomous regions, and municipalities directly under the central government shall be filed with the drug regulatory authority of the State Council. Herbs that do not comply with the national pharmaceutical standards or are not processed in accordance with the processing specifications formulated by the drug regulatory authorities of the people's governments of provinces, autonomous regions, and municipalities directly under the central government may not be manufactured for sale or sold on the market.

　　Article 45: The raw materials and excipients required for the manufacture of pharmaceutical products shall meet the relevant requirements for pharmaceutical use and the Good Manufacturing Practice for Pharmaceutical Products.

　　When manufacturing pharmaceutical products, suppliers of raw materials, excipients, and other inputs shall be audited in accordance with applicable regulations to ensure that the purchased and used raw materials, excipients, and other inputs meet the requirements specified in the preceding paragraph.

　　Article 46: Packaging materials and containers that come into direct contact with pharmaceutical products shall meet pharmaceutical requirements and comply with standards that ensure human health and safety.

　　Packaging materials and containers that do not meet the requirements for direct contact with pharmaceutical products shall be ordered by the drug regulatory authorities to cease use.

　　Article 47: Pharmaceutical manufacturers shall conduct quality inspections on pharmaceutical products. Products that do not meet national pharmaceutical standards shall not be released from the factory.

　　Drug manufacturers shall establish procedures for the release of drugs from the factory, clearly defining the standards and conditions for such release. Only drugs that meet the specified standards and conditions may be released after being signed off by the person authorized for quality.

　　Article 48: Pharmaceutical packaging shall be suitable for the quality requirements of the drugs and convenient for storage, transportation, and medical use.

　　Chinese medicinal materials being shipped shall be packaged. Each package shall clearly indicate the product name, place of origin, date of manufacture, and supplier’s name, and shall also bear a mark certifying quality compliance.

　　Article 49: Pharmaceutical packaging shall be labeled or labeled with tags as required and accompanied by an instruction manual.

　　The label or package insert shall indicate the generic name of the drug, its ingredients, specifications, the holder of the marketing authorization and its address, the manufacturer and its address, the approval number, the batch number, the date of manufacture, the expiration date, the indications or primary therapeutic uses, the dosage and administration instructions, contraindications, adverse reactions, and precautions. The text on the label and package insert shall be clear and legible; items such as the date of manufacture and expiration date shall be prominently marked and easily identifiable.

　　The labels and package inserts for narcotic drugs, psychotropic drugs, toxic medicinal products for medical use, radioactive drugs, topical medications, and over-the-counter drugs shall bear the prescribed markings.

　　Article 50: Personnel directly involved in handling pharmaceutical products—such as marketing authorization holders, pharmaceutical manufacturers, pharmaceutical distributors, and medical institutions—shall undergo annual health examinations. Individuals suffering from infectious diseases or other conditions that could contaminate pharmaceutical products shall not be permitted to engage in work involving direct contact with pharmaceutical products.

Chapter 5: Pharmaceutical Distribution

　　Article 51: To engage in wholesale drug distribution, one must obtain a drug distribution license after approval by the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the central government where the business is located. To engage in retail drug sales, one must obtain a drug distribution license after approval by the drug supervision and administration department of the local people's government at or above the county level where the business is located. No person may engage in drug distribution without a drug distribution license.

　　A pharmaceutical business license shall indicate its validity period and scope of business, and shall be re-examined and reissued upon expiration.

　　When the drug regulatory authority issues drug business licenses, in addition to meeting the conditions stipulated in Article 52 of this Law, it shall also adhere to the principle of facilitating public access to medications.

　　Article 52: Entities engaged in pharmaceutical business activities shall meet the following conditions:

　　(1) There shall be pharmacists or other pharmaceutical technicians who have been legally qualified and certified;

　　(2) Possess business premises, equipment, storage facilities, and sanitary conditions that are suitable for the pharmaceutical products being operated;

　　(3) Have a quality management organization or personnel that are suitable for the pharmaceutical products being operated;

　　(4) There shall be established regulations and systems to ensure drug quality, and these shall comply with the Good Supply Practice requirements for pharmaceutical distribution formulated by the drug regulatory authority under the State Council in accordance with this Law.

　　Article 53: Those engaged in pharmaceutical distribution activities shall comply with the Good Distribution Practice for Pharmaceuticals, establish and improve a pharmaceutical distribution quality management system, and ensure that the entire pharmaceutical distribution process continuously meets statutory requirements.

　　The state encourages and guides the chain operation of pharmaceutical retail businesses. The headquarters of enterprises engaged in chain pharmaceutical retail operations shall establish a unified quality management system and assume management responsibilities for the business activities of their affiliated retail outlets.

　　The legal representative and the principal person in charge of a pharmaceutical enterprise shall bear full responsibility for the pharmaceutical business activities of their enterprise.

　　Article 54: The State shall implement a classification management system for pharmaceuticals, dividing them into prescription drugs and over-the-counter (OTC) drugs. Specific measures shall be formulated by the drug regulatory authority under the State Council in conjunction with the health authority under the State Council.

　　Article 55: Holders of drug marketing authorization, drug manufacturers, drug distributors, and medical institutions shall procure drugs from holders of drug marketing authorization or from enterprises qualified to manufacture and distribute drugs; however, this does not apply to the procurement of Chinese medicinal materials that are not subject to approval and regulatory management.

　　Article 56: Pharmaceutical enterprises purchasing drugs shall establish and implement a system for inspecting and accepting incoming goods, verifying the drug’s qualification certificates and other markings. Drugs that do not meet the prescribed requirements shall not be purchased or sold.

　　Article 57: Pharmaceutical enterprises engaged in the purchase and sale of pharmaceutical products shall maintain true and complete records of such transactions. These records shall include the generic name, dosage form, specification, batch number, expiration date, marketing authorization holder, manufacturer, purchasing and selling entity, quantity purchased or sold, purchase or sale price, date of purchase or sale, and other information as prescribed by the drug regulatory authority under the State Council.

　　Article 58: When retailing pharmaceutical products, pharmaceutical enterprises shall ensure accuracy and provide clear instructions on usage, dosage, and precautions. Prescriptions must be carefully checked before dispensing, and no changes or substitutions may be made to the medications listed on the prescription without authorization. Prescriptions containing drug interactions or exceeding the recommended dosage shall be refused for dispensing. If necessary, the prescription must be corrected or re-signed by the prescribing physician before it can be dispensed.

　　Pharmaceutical enterprises selling Chinese medicinal materials shall indicate the place of origin.

　　Pharmacists or other pharmaceutical technicians who have been legally qualified are responsible for drug management, prescription review and dispensing, and guidance on the rational use of medications within this enterprise.

　　Article 59: Pharmaceutical enterprises shall establish and implement a pharmaceutical storage system and adopt necessary measures, such as refrigeration, freeze protection, moisture prevention, insect control, and rodent control, to ensure the quality of pharmaceutical products.

　　A check system shall be implemented for the receipt and dispatch of pharmaceutical products.

　　Article 60: Urban and rural marketplaces may sell Chinese medicinal materials, unless otherwise provided by the State Council.

　　Article 61: Holders of drug marketing authorization and pharmaceutical enterprises engaging in the online sale of drugs shall comply with the relevant provisions on pharmaceutical distribution stipulated in this Law. Specific administrative measures shall be formulated by the drug regulatory authority under the State Council in conjunction with the health authorities under the State Council and other relevant departments.

　　Drugs subject to special state regulations—such as vaccines, blood products, anesthetic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, and drug-related chemicals that are easy to synthesize into controlled substances—may not be sold online.

　　Article 62: Providers of third-party platforms for online drug trading shall, in accordance with the regulations of the drug supervision and administration department under the State Council, file a record with the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the central government where they are located.

　　Third-party platform providers shall, in accordance with the law, review the qualifications of marketing authorization holders and pharmaceutical enterprises applying to operate on the platform, ensuring that they meet statutory requirements, and shall also manage pharmaceutical business activities occurring on the platform.

　　If a third-party platform provider discovers that a marketing authorization holder or a pharmaceutical enterprise operating on the platform is engaging in activities that violate the provisions of this Law, it shall promptly put a stop to such activities and immediately report them to the drug supervision and administration department of the county-level people's government in the locality. In the event of discovering serious violations, the platform provider shall immediately cease providing online trading platform services.

　　Article 63: Medicinal materials newly discovered or introduced from abroad may be sold only after obtaining approval from the drug supervision and administration department under the State Council.

　　Article 64: Medicines shall be imported through ports authorized to import pharmaceutical products, and the importing enterprise shall file a record with the drug regulatory authority at the port of entry. Customs shall process the clearance procedures based on the Import Drug Clearance Certificate issued by the drug regulatory authority. Without such a certificate, customs shall not release the goods.

　　The drug regulatory authority at the port of entry shall notify the drug testing institution to conduct random inspections of imported drugs in accordance with the regulations of the drug regulatory authority under the State Council.

　　The ports authorized to import pharmaceutical products shall be proposed by the drug regulatory authority under the State Council in conjunction with the General Administration of Customs, and submitted to the State Council for approval.

　　Article 65: If a medical institution needs to import a small quantity of drugs urgently for clinical use, it may do so upon approval by the drug regulatory authority under the State Council or by the people's governments of provinces, autonomous regions, and municipalities directly under the central government authorized by the State Council. The imported drugs shall be used exclusively for specified medical purposes within designated medical institutions.

　　For personal use, bringing in a small quantity of medications into the country shall be handled in accordance with relevant national regulations.

　　Article 66: The import and export of narcotic drugs and psychotropic substances within the scope prescribed by the State shall require an import permit or an export permit issued by the drug supervision and administration department under the State Council.

　　Article 67: The import of pharmaceutical products with uncertain efficacy, significant adverse reactions, or that pose a risk to human health for other reasons is prohibited.

　　Article 68: The drug regulatory authority under the State Council shall, prior to sale or import, designate a drug testing institution to conduct inspections on the following drugs. Drugs that have not been inspected or that fail inspection shall not be sold or imported:

　　(1) Pharmaceuticals first sold within the territory of China;

　　(2) Biological products specified by the drug regulatory authority under the State Council;

　　(3) Other drugs prescribed by the State Council.

　　Chapter Six: Pharmaceutical Management in Medical Institutions

　　Article 69: Medical institutions shall be equipped with pharmacists or other pharmaceutical technicians who have been legally qualified and certified, and who shall be responsible for tasks such as drug management, prescription review and dispensing, and guidance on the rational use of medications within their respective institutions. Non-pharmaceutical personnel are prohibited from directly engaging in pharmaceutical technical work.

　　Article 70: When purchasing pharmaceutical products, medical institutions shall establish and implement a system for inspecting and accepting incoming goods, verifying the product’s qualification certificates and other identifying marks. Products that do not meet the prescribed requirements shall not be purchased or used.

　　Article 71: Medical institutions shall have premises, equipment, storage facilities, and sanitary conditions that are appropriate for the pharmaceuticals they use. They shall establish and implement a pharmaceutical management system and adopt necessary measures—including refrigeration, freeze protection, moisture prevention, pest control, and rodent control—to ensure the quality of pharmaceuticals.

　　Article 72: Medical institutions shall adhere to the principles of safe, effective, and economically reasonable drug use, follow clinical guidelines for drug application, clinical diagnosis and treatment guidelines, and drug package inserts, and conduct reviews to ensure the appropriateness of physicians’ prescriptions and medication orders.

　　Other entities that use pharmaceutical products outside of medical institutions shall comply with the provisions of this Law regarding the use of pharmaceutical products by medical institutions.

　　Article 73: Pharmacists or other pharmaceutical technicians who have been legally qualified and authorized shall verify prescriptions before dispensing them. They must not alter or substitute any of the medications listed on the prescription without authorization. Prescriptions containing drug interactions or exceeding the prescribed dosage shall be refused for dispensing. If necessary, such prescriptions may only be dispensed after being corrected or re-signed by the prescribing physician.

　　Article 74: Medical institutions intending to prepare pharmaceutical preparations shall obtain approval from the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the central government where they are located and acquire a Medical Institution Preparation License. No medical institution may prepare pharmaceutical preparations without holding such a license.

　　The license for pharmaceutical preparations issued by medical institutions shall indicate an expiration date and be subject to re-examination and renewal upon expiration.

　　Article 75: Medical institutions preparing pharmaceutical preparations shall have facilities, management systems, testing instruments, and hygienic conditions that can ensure the quality of the preparations.

　　Preparations compounded by medical institutions shall be manufactured in accordance with the approved manufacturing processes, and the raw materials, excipients, packaging materials, and other related substances required shall meet pharmaceutical standards.

　　Article 76: Preparations compounded by medical institutions shall be varieties that are clinically needed by the institution itself but not available on the market, and shall be approved by the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the central government where the institution is located; however, this does not apply to Chinese medicinal preparations compounded in accordance with special provisions of law.

　　Preparations compounded by medical institutions shall undergo quality inspection in accordance with applicable regulations. Only those that pass the inspection may be used within the institution upon presentation of a physician’s prescription. With approval from the drug regulatory authority under the State Council or the drug regulatory authority of the people’s governments of provinces, autonomous regions, or municipalities directly under the central government, preparations compounded by medical institutions may be transferred and used among designated medical institutions.

　　Preparations compounded by medical institutions may not be sold on the market.

　　Chapter 7: Post-Marketing Drug Management

　　Article 77: The marketing authorization holder of a pharmaceutical product shall develop a post-marketing risk management plan, proactively conduct post-marketing studies to further confirm the safety, efficacy, and controllability of quality of the drug, and strengthen ongoing management of drugs already on the market.

　　Article 78: For drugs approved under conditional approval, the marketing authorization holder shall adopt appropriate risk management measures and complete the required studies within the prescribed time limit. If the holder fails to complete the studies as required by the deadline or cannot demonstrate that the benefits of the drug outweigh its risks, the drug regulatory authority under the State Council shall take legal action accordingly, up to and including revocation of the drug registration certificate.

　　Article 79: Changes occurring during the pharmaceutical manufacturing process shall be categorized and managed according to their degree of risk and impact on the safety, efficacy, and controllability of quality of the drug. Major changes shall be approved by the drug regulatory authority under the State Council; other changes shall be filed or reported in accordance with the regulations of the drug regulatory authority under the State Council.

　　The marketing authorization holder of a drug shall, in accordance with the regulations of the drug regulatory authority under the State Council, comprehensively assess and verify the impact of the proposed changes on the drug’s safety, efficacy, and quality control.

　　Article 80: The marketing authorization holder of a drug shall conduct post-marketing surveillance for adverse reactions, proactively collect and track the analysis of suspected adverse drug reaction information, and promptly implement risk control measures for drugs whose risks have been identified.

　　Article 81: Holders of drug marketing authorization, pharmaceutical manufacturers, pharmaceutical distributors, and medical institutions shall regularly monitor the quality, efficacy, and adverse reactions of drugs they produce, distribute, and use. If any suspected adverse reactions are identified, they shall promptly report such cases to the drug regulatory authorities and the health authorities. Specific measures shall be formulated jointly by the drug regulatory authority under the State Council and the health authority under the State Council.

　　For drugs for which serious adverse reactions have been confirmed, the drug regulatory authority under the State Council or the drug regulatory authority of the people's governments of provinces, autonomous regions, and municipalities directly under the central government shall, based on actual circumstances, take urgent control measures such as halting production, sales, and use. They shall also organize an assessment within five days and, within fifteen days from the date the assessment conclusion is reached, make an administrative decision in accordance with the law.

　　Article 82: If a pharmaceutical product has quality issues or other safety risks, the marketing authorization holder shall immediately cease sales, notify relevant pharmaceutical distributors and medical institutions to stop sales and use of the product, recall the already sold products, promptly disclose recall information, and, if necessary, immediately halt production. The holder shall also report the details of the recall and its handling to the drug regulatory authorities and health authorities of the provincial, autonomous region, or municipality governments. Pharmaceutical manufacturers, pharmaceutical distributors, and medical institutions shall cooperate accordingly.

　　If the marketing authorization holder of a drug fails to recall the drug as required by law, the drug supervision and administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the central government shall order it to carry out the recall.

　　Article 83: The marketing authorization holder of a drug shall conduct periodic post-marketing evaluations of the safety, efficacy, and quality controllability of drugs already on the market. If necessary, the drug regulatory authority under the State Council may order the marketing authorization holder to carry out a post-marketing evaluation or directly undertake such an evaluation itself.

　　After evaluation, drug registration certificates shall be revoked for drugs whose efficacy is uncertain, have significant adverse reactions, or pose health risks to humans for other reasons.

　　Medicines whose drug registration certificates have been revoked may not be manufactured, imported, sold, or used.

　　Medicines whose drug registration certificates have been revoked or that have exceeded their validity periods shall be supervised for destruction by the drug regulatory authorities or subjected to other harmless treatment measures in accordance with the law.

　　Chapter 8: Drug Prices and Advertising

　　Article 84: The State shall improve the drug procurement management system, monitor drug prices, conduct cost and price surveys, strengthen supervision and inspection of drug prices, and, in accordance with the law, investigate and punish illegal activities such as price monopolies and excessive price hikes, thereby maintaining order in drug pricing.

　　Article 85: For pharmaceutical products subject to market-regulated pricing in accordance with the law, the marketing authorization holder, pharmaceutical manufacturer, pharmaceutical distributor, and medical institution shall set prices based on the principles of fairness, reasonableness, honesty and good faith, and value for money, thereby providing users with pharmaceutical products at reasonable prices.

　　Holders of drug marketing authorization, pharmaceutical manufacturers, pharmaceutical distributors, and medical institutions shall comply with the regulations on drug price management issued by the competent authority for drug pricing under the State Council, formulate and clearly indicate retail prices for drugs, and are prohibited from engaging in practices such as excessive profits, price monopolies, and price fraud.

　　Article 86: Holders of drug marketing authorization, pharmaceutical manufacturers, pharmaceutical distributors, and medical institutions shall, in accordance with the law, provide the drug pricing authorities with information such as the actual purchase and sales prices and quantities of their drugs.

　　Article 87: Medical institutions shall provide patients with a price list of the medications they use, truthfully disclose the prices of commonly used medications in accordance with applicable regulations, and strengthen the management of rational drug use. Specific measures shall be formulated by the health authority under the State Council.

　　Article 88: Holders of drug marketing authorization, pharmaceutical manufacturers, pharmaceutical distributors, and medical institutions are prohibited from offering or accepting kickbacks or other improper benefits in the purchase and sale of drugs.

　　It is prohibited for holders of drug marketing authorization, pharmaceutical manufacturers, pharmaceutical distributors, or their agents to provide, under any pretext, financial benefits or other improper advantages to persons such as heads of medical institutions that use their drugs, drug procurement personnel, physicians, pharmacists, and other relevant staff. It is also prohibited for heads of medical institutions, drug procurement personnel, physicians, pharmacists, and other relevant staff to accept, under any pretext, financial benefits or other improper advantages from holders of drug marketing authorization, pharmaceutical manufacturers, pharmaceutical distributors, or their agents.

　　Article 89: Pharmaceutical advertisements shall be approved by the advertising review authority designated by the people's governments of the provinces, autonomous regions, and municipalities directly under the central government where the advertiser is located; no advertisement may be published without such approval.

　　Article 90: The content of pharmaceutical advertisements shall be truthful and lawful, and shall conform to the drug instructions approved by the drug regulatory authority under the State Council. Such advertisements shall not contain any false information.

　　Drug advertisements shall not contain assertions or guarantees regarding efficacy or safety; nor shall they use the names or images of state organs, research institutions, academic organizations, industry associations, or experts, scholars, physicians, pharmacists, patients, and the like for endorsement or certification.

　　Non-pharmaceutical advertisements shall not include any promotion related to pharmaceutical products.

　　Article 91: With regard to drug prices and advertising, where this Law does not provide specific regulations, the provisions of the “Price Law of the People’s Republic of China,” the “Anti-Monopoly Law of the People’s Republic of China,” the “Anti-Unfair Competition Law of the People’s Republic of China,” and the “Advertising Law of the People’s Republic of China,” among others, shall apply.

　　Chapter 9: Pharmaceutical Reserves and Supply

　　Article 92: The State shall implement a pharmaceutical reserve system and establish pharmaceutical reserves at both the central and local levels.

　　In the event of a major disaster, epidemic, or other emergency, pharmaceuticals may be urgently requisitioned in accordance with the provisions of the "Emergency Response Law of the People's Republic of China."

　　Article 93: The State shall implement a system of essential medicines, select an appropriate number of essential medicine varieties, strengthen the organization of production and stockpiling, enhance the supply capacity of essential medicines, and meet the basic medication needs for disease prevention and treatment.

　　Article 94: The State shall establish a monitoring system for the supply and demand of pharmaceuticals, promptly collect, compile, and analyze information on the supply and demand of shortage drugs, implement early warnings for shortage drugs, and adopt appropriate response measures.

　　Article 95: The State shall implement a management system for a list of shortage drugs. Specific measures shall be formulated by the health authority under the State Council in conjunction with the drug regulatory authority under the State Council and other relevant departments.

　　If the marketing authorization holder of a drug ceases production of a shortage drug, it shall, in accordance with the relevant regulations, report to the drug regulatory authority under the State Council or the drug regulatory authority of the people's government of a province, autonomous region, or municipality directly under the central government.

　　Article 96: The State encourages the research and development and production of drugs in short supply. Priority review and approval shall be granted to new drugs urgently needed in clinical practice, as well as to new drugs for the prevention and treatment of major infectious diseases and rare diseases.

　　Article 97: The State Council may impose restrictions on or prohibit the export of shortage drugs. When necessary, relevant departments of the State Council may take measures such as organizing production, intervening in prices, and expanding imports to ensure the supply of these drugs.

　　The marketing authorization holder, pharmaceutical manufacturer, and pharmaceutical distributor shall, in accordance with applicable regulations, ensure the production and supply of pharmaceutical products.

　　Chapter Ten: Supervision and Management

　　Article 98: The production (including formulation, the same applies hereinafter), sale, and use of counterfeit drugs and substandard drugs are prohibited.

　　A drug is considered counterfeit if any of the following circumstances apply:

　　(1) The ingredients contained in the drug do not conform to the ingredients specified in the national drug standards;

　　(2) Impersonating a drug with a non-drug product or impersonating one type of drug with another type of drug;

　　(3) Deteriorated pharmaceutical products;

　　(4) The indicated therapeutic indications or primary functions of the drug exceed the prescribed scope.

　　A drug is considered substandard if any of the following circumstances apply:

　　(1) The content of the drug’s ingredients does not meet the national pharmaceutical standards;

　　(2) Contaminated pharmaceutical products;

　　(3) Medicines without a stated or altered expiration date;

　　(4) Medicines for which the batch number is not indicated or has been altered;

　　(5) Medicines that have exceeded their expiration date;

　　(6) Medicines that have been illegally added with preservatives or excipients;

　　(7) Other pharmaceutical products that do not meet pharmaceutical standards.

　　The production and import of pharmaceutical products without obtaining the required drug approval documents are prohibited. The use of active pharmaceutical ingredients, packaging materials, and containers that have not been reviewed and approved in accordance with regulations for the manufacture of pharmaceutical products is also prohibited.

　　Article 99: The drug regulatory authorities shall, in accordance with the provisions of laws and regulations, conduct supervision and inspection over activities such as drug research and development, manufacturing, distribution, and the use of drugs by drug-using entities. When necessary, they may extend their inspections to entities and individuals that provide products or services for drug research and development, manufacturing, distribution, and use. Relevant entities and individuals shall cooperate fully and shall not refuse or conceal any information.

　　The drug regulatory authorities shall conduct focused supervision and inspection on high-risk drugs.

　　For products for which there is evidence suggesting potential safety risks, the drug regulatory authorities, based on the results of supervision and inspection, shall take measures such as issuing warnings, conducting interviews, setting deadlines for corrective actions, and suspending production, sales, use, or import, and shall promptly publish the outcomes of the inspections and related actions.

　　When conducting supervision and inspection, the drug regulatory authority shall present supporting documentation and shall keep confidential any trade secrets learned during the course of such supervision and inspection.

　　Article 100: The drug regulatory authority may, based on its supervisory and administrative needs, conduct random inspections and tests of drug quality. Such random inspections and tests shall be conducted in accordance with prescribed sampling procedures and shall not involve any fees; samples for testing shall be purchased. The expenses required shall be covered in accordance with the provisions of the State Council.

　　For pharmaceutical products and related materials for which there is evidence suggesting they may pose a hazard to human health, the drug regulatory authorities may seize and detain them and shall make an administrative decision within seven days. If the pharmaceutical products require testing, the administrative decision shall be made within fifteen days from the date the test report is issued.

　　Article 101: The drug regulatory authorities under the State Council and the people's governments of provinces, autonomous regions, and municipalities directly under the central government shall periodically publish the results of random inspections and tests of drug quality. If a publication is inappropriate, it shall be corrected within the scope of the original publication.

　　Article 102: If a party disagrees with the results of a drug inspection, it may, within seven days from the date of receipt of the inspection results, apply for a re-inspection to the original drug inspection agency or to a drug inspection agency established or designated by the higher-level drug regulatory authority. Alternatively, the party may directly apply for a re-inspection to a drug inspection agency established or designated by the State Council’s drug regulatory authority. The drug inspection agency accepting the re-inspection application shall render its re-inspection conclusion within the time limit prescribed by the State Council’s drug regulatory authority.

　　Article 103: The drug regulatory authority shall inspect the holders of drug marketing authorization, drug manufacturers, drug distributors, non-clinical safety evaluation research institutions, and clinical trial institutions to ensure their compliance with the Good Manufacturing Practice for Drugs, the Good Distribution Practice for Drugs, the Good Laboratory Practice for Non-Clinical Drug Studies, and the Good Clinical Practice for Drug Trials, and shall supervise their ongoing compliance with statutory requirements.

　　Article 104: The State shall establish a professional and specialized team of drug inspectors. Inspectors shall be familiar with pharmaceutical laws and regulations and possess specialized knowledge in the field of pharmaceuticals.

　　Article 105: The drug regulatory authority shall establish credit files for holders of drug marketing authorization, pharmaceutical manufacturers, pharmaceutical distributors, non-clinical safety evaluation research institutions, clinical trial institutions, and medical institutions, recording information such as license issuance, results of routine supervision and inspection, and handling of illegal activities. Such information shall be made public to the society in accordance with the law and updated promptly. For entities with adverse credit records, the frequency of supervision and inspection shall be increased, and joint punitive measures may be implemented in accordance with national regulations.

　　Article 106: The drug regulatory authority shall publish its email address and telephone number to receive inquiries, complaints, and reports, and shall promptly respond to, verify, and handle them in accordance with the law. For reports that are verified as true, the informant shall be rewarded in accordance with relevant regulations.

　　The drug regulatory authority shall keep the whistleblower’s information confidential and protect the whistleblower’s legitimate rights and interests. If a whistleblower reports misconduct within their own organization, that organization shall not retaliate against the whistleblower by terminating or amending the employment contract or through any other means.

　　Article 107: The State shall implement a unified system for the public disclosure of drug safety information. The overall national situation regarding drug safety, risk alerts concerning drug safety, information on major drug safety incidents and their investigation and handling, as well as other information designated by the State Council for unified public disclosure, shall be uniformly released by the drug supervision and administration department under the State Council. If risk alerts concerning drug safety and information on major drug safety incidents and their investigation and handling are limited in scope to specific regions, they may also be released by the drug supervision and administration departments of the people's governments of the relevant provinces, autonomous regions, and municipalities directly under the central government. No one may release the aforementioned information without authorization.

　　When releasing drug safety information, it shall be timely, accurate, and comprehensive, and accompanied by necessary explanations to avoid causing misinterpretation.

　　No organization or individual shall fabricate or disseminate false information about drug safety.

　　Article 108: People's governments at or above the county level shall formulate emergency response plans for drug safety incidents. Holders of drug marketing authorization, drug manufacturers, drug distributors, and medical institutions shall each develop their own drug safety incident response plans and organize training and emergency drills accordingly.

　　In the event of a pharmaceutical safety incident, the people's governments at or above the county level shall immediately organize and carry out response efforts in accordance with the emergency plan. Relevant entities shall immediately take effective measures to handle the situation and prevent the harm from spreading.

　　Article 109: If the drug regulatory authority fails to promptly identify systemic risks to drug safety or to promptly eliminate potential safety hazards within its jurisdiction, the people's government at the same level or the drug regulatory authority of the higher-level people's government shall conduct a talk with its principal person in charge.

　　If a local people's government fails to fulfill its responsibilities for drug safety and fails to promptly eliminate major regional drug safety hazards, the higher-level people's government or the drug supervision and administration department of the higher-level people's government shall hold a talk with its principal person in charge.

　　The departments and local people's governments that have been summoned for talks shall immediately take measures to rectify their drug supervision and management work.

　　The results of the interviews and the status of corrective actions shall be included in the evaluation and assessment records of drug supervision and management work conducted by relevant departments and local people's governments.

　　Article 110: Local people's governments and their drug regulatory authorities shall not, by requiring drug testing, approval, or other similar measures, restrict or exclude drugs produced by marketing authorization holders and pharmaceutical manufacturers outside the region from entering the local market.

　　Article 111: The drug regulatory authorities and any specialized technical institutions for drugs established or designated by them shall not engage in pharmaceutical production and marketing activities, nor shall they recommend, supervise the manufacture of, or oversee the sale of drugs in their own name.

　　Staff members of drug regulatory authorities and their designated or appointed pharmaceutical technical institutions shall not engage in pharmaceutical production and business activities.

　　Article 112: If the State Council has other special regulatory provisions regarding narcotic drugs, psychotropic substances, toxic medicinal products for medical use, radioactive drugs, and drug-related precursors that are easily used for illicit drug production, such provisions shall be followed.

　　Article 113: If the drug regulatory authority discovers that a drug-related violation is suspected of constituting a crime, it shall promptly transfer the case to the public security authorities.

　　If a case does not require criminal prosecution under the law or is exempt from criminal punishment but should still be subject to administrative liability, the public security organs, the People's Procuratorate, and the People's Court shall promptly transfer the case to the drug administration department.

　　If the public security organs, the People's Procuratorate, and the People's Court request the drug administration department, the environmental protection authorities, and other relevant departments to provide inspection conclusions, identification opinions, and assistance in rendering the drugs involved harmless, such departments shall promptly provide the requested information and render the necessary assistance.

　　Chapter Eleven: Legal Liability

　　Article 114: Any violation of the provisions of this Law that constitutes a crime shall be subject to criminal liability in accordance with the law.

　　Article 115: Anyone who produces or sells pharmaceutical products without obtaining a Pharmaceutical Production License, a Pharmaceutical Distribution License, or a Medical Institution Preparation License shall be ordered to cease operations, have the illegally produced and sold pharmaceutical products and any illegal gains confiscated, and be fined an amount between fifteen and thirty times the value of the illegally produced and sold pharmaceutical products (including both those already sold and those not yet sold; the same applies hereinafter). If the value of the goods is less than 100,000 yuan, the fine shall be calculated based on 100,000 yuan.

　　Article 116: For the production and sale of counterfeit drugs, the illegally produced and sold drugs and any illegal gains shall be confiscated; the entity shall be ordered to suspend production and business operations for rectification; its drug approval certificates shall be revoked; and a fine shall be imposed ranging from fifteen to thirty times the value of the illegally produced and sold drugs. If the value of the drugs is less than 100,000 yuan, it shall be calculated as 100,000 yuan. In cases of serious circumstances, the entity’s drug production license, drug distribution license, or medical institution preparation license shall be revoked, and its corresponding applications will not be accepted for ten years. If the marketing authorization holder of the drug is an overseas enterprise, the import of its drugs shall be prohibited for ten years.

　　Article 117: For the production or sale of substandard drugs, the illegally produced and sold drugs as well as any illegal gains shall be confiscated, and a fine shall be imposed ranging from ten to twenty times the value of the illegally produced or sold drugs. If the value of the illegally produced or wholesale drugs is less than 100,000 yuan, it shall be calculated as 100,000 yuan; if the value of the illegally retailed drugs is less than 10,000 yuan, it shall be calculated as 10,000 yuan. In cases of serious violations, the authorities may order suspension of production and business operations for rectification, up to and including revocation of the drug approval documents, drug manufacturing licenses, drug distribution licenses, or pharmaceutical preparation licenses for medical institutions.

　　If Chinese medicinal herbs prepared for consumption or sold do not meet pharmaceutical standards but do not yet affect safety or efficacy, the violator shall be ordered to make corrections within a specified time limit and given a warning; a fine of between 100,000 and 500,000 yuan may also be imposed.

　　Article 118: For the production or sale of counterfeit drugs, or for the production or sale of substandard drugs under serious circumstances, the legal representative, principal person in charge, directly responsible supervisor, and other persons bearing responsibility shall have their income earned by the entity during the period when the illegal act occurred confiscated, and shall also be fined an amount ranging from 30 percent to three times the income thus obtained. They shall be permanently banned from engaging in pharmaceutical production and business activities, and may additionally be detained by public security authorities for a period of no less than five days and no more than fifteen days.

　　The raw materials, excipients, packaging materials, and production equipment specifically used by producers to manufacture counterfeit or substandard drugs shall be confiscated.

　　Article 119: If a unit that uses pharmaceutical products uses counterfeit or substandard drugs, it shall be penalized according to the provisions applicable to the sale of counterfeit drugs or the retail sale of substandard drugs. In cases of serious circumstances, if the legal representative, principal person in charge, directly responsible supervisor, and other persons bearing responsibility hold practicing certificates for medical and health personnel, their practicing certificates shall also be revoked.

　　Article 120: Anyone who provides convenience—such as storage or transportation—for drugs known or reasonably expected to be counterfeit, substandard, or falling under any of the categories specified in Article 124, paragraph 1, items 1 through 5 of this Law shall have all proceeds from such storage and transportation confiscated and shall also be fined an amount between one and five times the illegal income. In cases of serious circumstances, the fine shall be between five and fifteen times the illegal income; if the illegal income is less than 50,000 yuan, it shall be calculated as 50,000 yuan.

　　Article 121: The penalty decision regarding counterfeit or substandard drugs shall, in accordance with the law, clearly state the quality inspection conclusion issued by the drug testing institution.

　　Article 122: Anyone who forges, alters, leases, lends, or illegally trades in licenses or drug approval documents shall have their illegal gains confiscated and be fined an amount between one and five times the illegal gains. In cases of serious circumstances, the fine shall be between five and fifteen times the illegal gains; the drug production license, drug distribution license, medical institution preparation license, or drug approval document shall also be revoked. The legal representative, principal person in charge, directly responsible supervisor, and other persons bearing responsibility shall each be fined between 20,000 yuan and 200,000 yuan, and shall be prohibited from engaging in drug production and distribution activities for ten years. Additionally, the public security authorities may impose a detention of between five and fifteen days. If the illegal gains are less than 100,000 yuan, the fine shall be calculated based on 100,000 yuan.

　　Article 123: Any entity that provides false certificates, data, materials, or samples, or employs other deceptive means to obtain licenses for clinical trials, drug production, drug distribution, preparation of pharmaceuticals by medical institutions, or drug registration shall have its relevant license revoked. The entity’s corresponding applications will not be accepted for ten years, and it shall also be fined between 500,000 yuan and 5 million yuan. In cases of serious circumstances, the legal representative, principal person in charge, directly responsible supervisor, and other persons bearing responsibility shall each be fined between 20,000 yuan and 200,000 yuan, and shall be prohibited from engaging in drug production and distribution activities for ten years. Additionally, the public security authorities may impose a detention of between five and fifteen days on such individuals.

　　Article 124: Any of the following acts in violation of the provisions of this Law shall be subject to confiscation of the illegally produced, imported, or sold pharmaceuticals, as well as any illegal gains derived therefrom, together with the raw materials, excipients, packaging materials, and production equipment specifically used for such illegal activities. The offender shall also be ordered to suspend production and business operations for rectification and fined an amount ranging from fifteen to thirty times the value of the illegally produced, imported, or sold pharmaceuticals. If the value of the goods is less than 100,000 yuan, it shall be calculated as 100,000 yuan. In cases of serious circumstances, the approval documents for the pharmaceuticals may be revoked, up to and including revocation of the pharmaceutical manufacturing license, pharmaceutical distribution license, or medical institution preparation license. The legal representative, principal person in charge, directly responsible supervisor, and other persons bearing responsibility shall have their income earned during the period when the illegal act occurred confiscated and shall also be fined an amount ranging from 30 percent to three times their earned income. They shall be banned from engaging in pharmaceutical production and distribution activities for a period ranging from ten years to life, and may additionally be detained by public security authorities for a period of between five and fifteen days.

　　(1) Manufacturing or importing pharmaceutical products without obtaining the required drug approval documents;

　　(2) Manufacturing or importing pharmaceutical products using drug approval documents obtained through deceptive means;

　　(3) Manufacturing pharmaceutical products using active pharmaceutical ingredients that have not been reviewed and approved;

　　(4) Selling pharmaceutical products without having them inspected when inspection is required;

　　(5) Producing or selling drugs prohibited by the drug regulatory authority under the State Council;

　　(6) Fabricating production and inspection records;

　　(7) Making significant changes during the pharmaceutical manufacturing process without prior approval.

　　Sales of the drugs specified in items 1 through 3 of the preceding paragraph, or the use of such drugs by drug-using units as specified in items 1 through 5 of the preceding paragraph, shall be subject to the penalties prescribed in the preceding paragraph. In cases of serious circumstances, if the legal representative, principal person in charge, directly responsible supervisor, and other persons bearing responsibility within the drug-using unit hold practicing certificates for medical and health personnel, their practicing certificates shall also be revoked.

　　For importing a small quantity of pharmaceutical products that have already been legally marketed abroad without prior approval, if the circumstances are relatively minor, the penalty may be reduced or waived in accordance with the law.

　　Article 125: Any of the following acts in violation of the provisions of this Law shall be subject to confiscation of illegally produced and sold pharmaceuticals, illegal proceeds, as well as packaging materials and containers; the entity shall be ordered to suspend production and business operations for rectification, and fined between 500,000 yuan and 5 million yuan. In cases of serious violations, the approval documents for pharmaceuticals, the pharmaceutical manufacturing license, and the pharmaceutical distribution license shall be revoked. The legal representative, principal person in charge, directly responsible supervisor, and other persons bearing responsibility shall each be fined between 20,000 yuan and 200,000 yuan, and shall be prohibited from engaging in pharmaceutical production and distribution activities for a period ranging from ten years to life.

　　(1) Conducting clinical trials of drugs without approval;

　　(2) Manufacturing pharmaceutical products using packaging materials or containers that have not been reviewed and approved for direct contact with drugs, or selling such pharmaceutical products;

　　(3) Using unlabeled or unapproved labels and instructions.

　　Article 126: Except as otherwise provided by this Law, if the marketing authorization holder of a drug, the drug manufacturer, the drug distributor, the non-clinical safety evaluation research institution, the clinical trial institution, and other relevant entities fail to comply with the Good Manufacturing Practice for Drugs, the Good Distribution Practice for Drugs, the Good Laboratory Practice for Non-Clinical Drug Studies, or the Good Clinical Practice for Drug Trials, they shall be ordered to make corrections within a specified time limit and given a warning. If they fail to make corrections within the prescribed time limit, they shall be fined between RMB 100,000 and RMB 500,000. In cases of serious violations, they shall be fined between RMB 500,000 and RMB 2 million, and ordered to suspend production and business operations for rectification up to revocation of their drug approval certificates, drug manufacturing licenses, and drug distribution licenses. Furthermore, the non-clinical safety evaluation research institutions and clinical trial institutions shall be prohibited from conducting non-clinical safety evaluations or clinical trials for five years. The legal representatives, principal persons in charge, directly responsible supervisors, and other persons bearing responsibility shall have all income earned by their respective entities during the period when the illegal act occurred confiscated, and shall also be fined an amount ranging from 10% to 50% of such income. They shall also be banned from engaging in drug production, distribution, and related activities for a period ranging from ten years to life.

　　Article 127: Any of the following acts in violation of the provisions of this Law shall be ordered to be rectified within a specified time limit and given a warning; if the rectification is not carried out within the prescribed time limit, a fine of between 100,000 and 500,000 yuan shall be imposed:

　　(1) Conducting bioequivalence studies without prior filing;

　　(2) During a clinical trial of a drug, if safety issues or other risks are identified but the sponsor of the clinical trial fails to promptly adjust the clinical trial protocol, suspend or terminate the trial, or fail to report such issues to the drug regulatory authority under the State Council;

　　(3) Failing to establish and implement a drug traceability system as required;

　　(4) Failure to submit the annual report as required;

　　(5) Failure to file or report changes in the pharmaceutical manufacturing process as required;

　　(6) A post-marketing risk management plan for the drug has not been developed;

　　(7) Failure to conduct post-marketing studies or post-marketing evaluations as required.

　　Article 128: Except where the violation is subject to penalties as counterfeit or substandard drugs according to law, if pharmaceutical packaging fails to bear labels or affix tags as required, or if the labels and instructions fail to indicate the relevant information or bear the prescribed markings as required, the violator shall be ordered to make corrections and given a warning. In cases of serious violations, the drug registration certificate shall be revoked.

　　Article 129: In violation of the provisions of this Law, if a marketing authorization holder, a pharmaceutical manufacturer, a pharmaceutical distributor, or a medical institution fails to purchase pharmaceutical products from the marketing authorization holder or from an enterprise qualified to manufacture or distribute pharmaceutical products, they shall be ordered to make corrections, have the illegally purchased pharmaceutical products and any illegal gains confiscated, and be fined an amount between two and ten times the value of the illegally purchased pharmaceutical products. In cases of serious violations, in addition to the above-mentioned penalties, the violator shall also be fined an amount between ten and thirty times the value of the pharmaceutical products, and their drug approval certificates, drug manufacturing licenses, drug distribution licenses, or medical institution practice licenses shall be revoked. If the value of the pharmaceutical products involved is less than 50,000 yuan, it shall be calculated as 50,000 yuan.

　　Article 130: In violation of the provisions of this Law, pharmaceutical enterprises that fail to keep records as required when purchasing or selling pharmaceutical products, retail pharmacies that fail to accurately explain instructions on usage and dosage, or pharmacies that fail to dispense prescriptions in accordance with the prescribed requirements shall be ordered to make corrections and receive a warning. In cases of serious violations, their pharmaceutical business license shall be revoked.

　　Article 131: In violation of the provisions of this Law, if a third-party platform provider for online drug trading fails to fulfill its obligations—including conducting qualification reviews, submitting reports, and ceasing to provide online trading platform services—the entity shall be ordered to make corrections, have its illegal gains confiscated, and be fined between 200,000 yuan and 2 million yuan. In cases of serious violations, the entity shall be ordered to suspend operations for rectification and be fined between 2 million yuan and 5 million yuan.

　　Article 132: For drugs that have already obtained drug registration certificates and are imported without having been filed with the drug regulatory authority at the port of entry authorized to allow drug imports as required, an order shall be issued requiring rectification within a specified time limit and a warning shall be given. If the rectification is not carried out within the prescribed time limit, the drug registration certificate shall be revoked.

　　Article 133: In violation of the provisions of this Law, if a medical institution sells preparations it has compounded on the market, it shall be ordered to make corrections, have the illegally sold preparations and any illegal gains confiscated, and be fined an amount between two and five times the value of the illegally sold preparations. In cases of serious violations, the fine shall be between five and fifteen times the value of the preparations. If the value of the preparations is less than 50,000 yuan, the fine shall be calculated based on 50,000 yuan.

　　Article 134: If the marketing authorization holder of a drug fails to conduct adverse drug reaction monitoring or report suspected adverse drug reactions as required, it shall be ordered to make corrections within a specified time limit and given a warning. If the holder fails to make corrections within the prescribed time limit, it shall be ordered to suspend production and business operations for rectification and fined between 100,000 yuan and 1 million yuan.

　　If a pharmaceutical enterprise fails to report suspected adverse drug reactions as required, it shall be ordered to make corrections within a specified time limit and given a warning. If the enterprise fails to make corrections within the prescribed time limit, it shall be ordered to suspend production and business operations for rectification and fined between 50,000 and 500,000 yuan.

　　If a medical institution fails to report suspected adverse drug reactions as required, it shall be ordered to make corrections within a specified time limit and given a warning. If it fails to make the corrections within the prescribed time limit, it shall be fined between 50,000 yuan and 500,000 yuan.

　　Article 135: If the marketing authorization holder of a drug, after being ordered by the drug regulatory authority of the provincial, autonomous region, or municipality people's government to recall the drug, refuses to do so, it shall be fined an amount between five and ten times the value of the drugs that should have been recalled. If the value of the drugs is less than 100,000 yuan, the fine shall be calculated based on 100,000 yuan. In cases of serious circumstances, the drug approval certificate, drug production license, and drug distribution license shall be revoked. The legal representative, principal person in charge, directly responsible supervisor, and other persons bearing responsibility shall each be fined between 20,000 yuan and 200,000 yuan. Drug manufacturers, drug distributors, and medical institutions that refuse to cooperate with the recall shall be fined between 100,000 yuan and 500,000 yuan.

　　Article 136: If the marketing authorization holder of a pharmaceutical product is a foreign enterprise, and the corporate legal entity designated by it within China fails to fulfill its relevant obligations as prescribed in this Law, the provisions of this Law concerning the legal liabilities of pharmaceutical marketing authorization holders shall apply.

　　Article 137: Any of the following acts shall be subject to enhanced punishment within the penalty range prescribed by this Law:

　　(1) Impersonating other drugs by using narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, or drug-related precursors that are easily used to manufacture drugs; or impersonating the aforementioned drugs by using other drugs.

　　(2) Manufacturing and selling counterfeit or substandard drugs primarily intended for use by pregnant women and children;

　　(3) The biological products manufactured and sold are counterfeit or substandard drugs;

　　(4) Producing and selling counterfeit or substandard drugs that result in personal injury;

　　(5) Producing or selling counterfeit drugs or substandard drugs and reoffending after having been dealt with;

　　(6) Refusing or evading supervision and inspection; falsifying, destroying, or concealing relevant evidence materials; or arbitrarily using seized or detained items.

　　Article 138: If a drug testing institution issues a false inspection report, it shall be ordered to make corrections and given a warning. The institution shall also be fined between 200,000 yuan and 1 million yuan. The directly responsible principal and other persons directly liable shall, in accordance with the law, be subject to disciplinary actions such as demotion, removal from office, or dismissal; their illegal gains shall be confiscated, and they shall be fined up to 50,000 yuan. In cases of serious violations, the institution’s qualification for conducting inspections shall be revoked. If the inspection results issued by a drug testing institution are inaccurate and cause losses, the institution shall bear corresponding compensation liability.

　　Article 139: The administrative penalties stipulated in Articles 115 through 138 of this Law shall be determined by the drug supervision and administration departments of the people's governments at or above the county level, according to their respective division of responsibilities. As for revoking permits or suspending license certificates, the decision shall be made by the original department that granted or approved such permits or licenses.

　　Article 140: If the holder of a drug marketing authorization, a drug manufacturer, a drug distributor, or a medical institution hires personnel in violation of the provisions of this Law, the drug regulatory authority or the health authority shall order such entity to terminate the employment relationship and impose a fine ranging from 50,000 yuan to 200,000 yuan.

　　Article 141: If the marketing authorization holder, pharmaceutical manufacturer, pharmaceutical distributor, or medical institution gives or accepts kickbacks or other improper benefits in the purchase and sale of pharmaceuticals; or if the marketing authorization holder, pharmaceutical manufacturer, pharmaceutical distributor, or their agents provide property or other improper benefits to responsible persons, pharmaceutical procurement personnel, physicians, pharmacists, or other relevant personnel of medical institutions that use their pharmaceutical products, the market supervision and administration department shall confiscate the illegal gains and impose a fine ranging from 300,000 yuan to 3 million yuan. In cases of serious violations, the business license of the marketing authorization holder, pharmaceutical manufacturer, or pharmaceutical distributor shall be revoked, and the drug administration department shall also revoke the drug approval certificate, drug production license, and drug distribution license.

　　If the marketing authorization holder, pharmaceutical manufacturer, or pharmaceutical distributor bribes state officials during the research, production, or distribution of pharmaceuticals, the legal representative, principal person in charge, directly responsible supervisor, and other persons bearing responsibility shall be permanently banned from engaging in pharmaceutical production and distribution activities.

　　Article 142: If the person in charge, procurement personnel, or other relevant personnel of a marketing authorization holder, a pharmaceutical manufacturer, or a pharmaceutical distributor receive property or other improper benefits from another marketing authorization holder, pharmaceutical manufacturer, pharmaceutical distributor, or their agents in the course of pharmaceutical procurement and sales, their illegal gains shall be confiscated and they shall be subject to penalties in accordance with the law. In cases of serious violations, they shall be prohibited from engaging in pharmaceutical production and business activities for a period of five years.

　　If persons in charge of medical institutions, drug procurement personnel, physicians, pharmacists, and other relevant personnel accept property or other improper benefits from holders of drug marketing authorizations, drug manufacturers, drug distributors, or their agents, they shall be subject to disciplinary action by the health authority or their own organization, and any illegal gains shall be confiscated. In cases of serious violations, their practice certificates shall also be revoked.

　　Article 143: Any violation of the provisions of this Law involving the fabrication or dissemination of false information on drug safety, if constituting an act violating public security administration, shall be subject to administrative punishment by the public security authorities in accordance with the law.

　　Article 144: If the marketing authorization holder of a drug, the drug manufacturer, the drug distributor, or a medical institution violates the provisions of this Law and causes harm to a patient, they shall bear compensation liability in accordance with the law.

　　If a person suffers damage due to the quality issues of a pharmaceutical product, the injured party may request compensation for losses from either the marketing authorization holder or the pharmaceutical manufacturer, or from the pharmaceutical distributor or medical institution. Upon receiving a claim for compensation from the injured party, the entity receiving the claim shall adopt a “first-responsible-party” system and make initial compensation payments. After making such initial payments, the entity may seek reimbursement according to law.

　　Anyone who produces counterfeit or substandard drugs, or who knowingly sells or uses such drugs, may, in addition to seeking compensation for losses, also request damages equal to ten times the purchase price or three times the amount of the loss suffered by the victim or their close relatives. If the additional compensation amount is less than 1,000 yuan, it shall be set at 1,000 yuan.

　　Article 145: If the drug supervision and administration department or any drug-related professional technical institution established or designated by it participates in drug production and business activities, its superior competent authority shall order it to make corrections and confiscate the illegal gains. In cases of serious violations, the directly responsible principal personnel and other persons directly liable shall be disciplined in accordance with the law.

　　Staff members of drug regulatory authorities or drug-related professional and technical institutions established or designated by them who engage in drug production and business activities shall be disciplined in accordance with the law.

　　Article 146: If the drug regulatory authority or a drug testing institution established or designated by it unlawfully collects testing fees during drug supervision and inspection, the relevant government authorities shall order it to refund the fees and impose disciplinary sanctions on the directly responsible principal personnel and other persons directly liable in accordance with the law. In cases of serious violations, their qualification for conducting testing shall be revoked.

　　Article 147: In violation of the provisions of this Law, if the drug regulatory authority engages in any of the following acts, it shall revoke the relevant permits and impose disciplinary sanctions on the directly responsible principal personnel and other persons directly liable in accordance with the law:

　　(1) Approving clinical trials of drugs when the conditions are not met;

　　(2) Issuing drug registration certificates for drugs that do not meet the requirements;

　　(3) Issuing drug production licenses, drug distribution licenses, or pharmaceutical preparation licenses for medical institutions to entities that do not meet the required conditions.

　　Article 148: In violation of the provisions of this Law, if the people's governments at or above the county level engage in any of the following acts, the directly responsible principal officials and other persons directly liable shall receive a record of demerit or a serious record of demerit; in cases of serious circumstances, they shall be subject to demotion, removal from office, or dismissal:

　　(1) Concealing, falsely reporting, delaying the reporting, or failing to report drug safety incidents;

　　(2) Failure to promptly eliminate major regional drug safety hazards, resulting in the occurrence of particularly serious drug safety incidents within the administrative jurisdiction, or the consecutive occurrence of serious drug safety incidents;

　　(3) Failing to perform duties effectively, resulting in serious adverse effects or significant losses.

　　Article 149: In violation of the provisions of this Law, if the drug administration and other relevant departments engage in any of the following acts, the directly responsible principal personnel and other persons directly liable shall receive a record of demerit or a serious record of demerit; for more serious cases, they shall be subject to demotion or removal from office; for extremely serious cases, they shall be dismissed:

　　(1) Concealing, falsely reporting, delaying the reporting, or failing to report drug safety incidents;

　　(2) Failure to promptly investigate and address identified violations of drug safety laws and regulations;

　　(3) Failure to promptly identify systemic risks in the drug safety system or failure to promptly eliminate potential safety hazards within the supervised and regulated area, resulting in serious consequences;

　　(4) Other instances of failing to fulfill drug supervision and management duties, resulting in serious adverse effects or significant losses.

　　Article 150: Personnel responsible for pharmaceutical supervision and administration who abuse their authority, engage in corruption and favoritism, or neglect their duties shall be disciplined according to law.

　　If there is negligence or dereliction of duty in the investigation and handling of illegal activities involving counterfeit or substandard drugs, the directly responsible officials and other persons bearing direct responsibility within the drug regulatory authorities shall be given stricter disciplinary measures in accordance with the law.

　　Article 151: The value of goods stipulated in this chapter shall be calculated based on the marked price of the illegally produced or sold pharmaceutical products; if no marked price is indicated, the value shall be calculated according to the market price of similar pharmaceutical products.

　　Chapter 12: Appendices then

　　Article 152: The management of the cultivation, harvesting, and husbandry of Chinese medicinal materials shall be carried out in accordance with the provisions of relevant laws and regulations.

　　Article 153: The administrative measures for regionally traditional folk medicinal materials shall be formulated jointly by the drug supervision and administration department under the State Council and the competent authority for traditional Chinese medicine under the State Council.

　　Article 154: The specific measures for the implementation of this Law by the Chinese People's Liberation Army and the Chinese People's Armed Police Force shall be formulated by the State Council and the Central Military Commission in accordance with this Law.

　　Article 155: This Law shall come into force on December 1, 2019.