Drug Administration Law of the People's Republic of China

Drug Administration Law of the People's Republic of China

(Adopted at the 7th Meeting of the Standing Committee of the 6th National People's Congress on September 20, 1984; 2001 Amended for the first time at the 20th Meeting of the Standing Committee of the 9th National People's Congress on February 28, 2001; First revision according to the Decision on Amending Seven Laws Including the "Marine Environmental Protection Law of the People's Republic of China" at the 6th Meeting of the Standing Committee of the 12th National People's Congress on December 28, 2013; Second revision according to the Decision on Amending the "Drug Administration Law of the People's Republic of China" at the 14th Meeting of the Standing Committee of the 12th National People's Congress on April 24, 2015; Second revision at the 12th Meeting of the Standing Committee of the 13th National People's Congress on August 26, 2019)

　　　　Contents
Chapter 1 General Provisions
Chapter 2 Drug Research and Registration
Chapter 3 Drug Marketing Authorization Holder
Chapter 4 Drug Production
Chapter 5 Drug Operation
Chapter 6 Pharmaceutical Affairs Management in Medical Institutions
Chapter 7 Post-Marketing Drug Management
Chapter 8 Drug Pricing and Advertising
Chapter 9 Drug Reserves and Supply
Chapter 10 Supervision and Administration
Chapter 11 Legal Liability
Chapter 12 Supplementary Provisions

Chapter 1 General Provisions

　　Article 1 This law is formulated to strengthen drug administration, ensure drug quality, safeguard public medication safety and legal rights, and protect and promote public health.
　　Article 2 This law applies to drug research, production, operation, use, and supervision activities within the territory of the People's Republic of China.
　　The drugs referred to in this law are substances used to prevent, treat, and diagnose human diseases, purposefully regulate human physiological functions, and have specified indications or main functions, usage, and dosage, including traditional Chinese medicine, chemical drugs, and biological products.
　　Article 3 Drug administration shall be centered on people's health, adhere to the principles of risk management, full-process control, and social co-governance, establish a scientific and strict supervision system, comprehensively improve drug quality, and ensure drug safety, efficacy, and accessibility.
　　Article 4 The state develops modern and traditional medicines, fully utilizing their roles in prevention, treatment, and health care.
The state protects wild medicinal resources and traditional Chinese medicine varieties and encourages the cultivation of authentic Chinese medicinal materials.
　　Article 5 The state encourages research and development of new drugs and protects the legal rights of citizens, legal persons, and other organizations in researching and developing new drugs.
　　Article 6 The state implements the drug marketing authorization holder system. The holder is legally responsible for the safety, efficacy, and quality control of drugs throughout the entire process of research, production, operation, and use.
　　Article 7 Those engaged in drug research, production, operation, and use shall comply with laws, regulations, rules, standards, and norms, ensuring that information throughout the process is true, accurate, complete, and traceable.
　　Article 8 The State Council's drug supervision and administration department is responsible for national drug supervision and administration. Relevant departments of the State Council are responsible for drug-related supervision within their respective duties. The drug supervision department cooperates with relevant departments of the State Council to implement national drug industry development plans and industrial policies.
　　The drug supervision departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for drug supervision within their administrative regions. The drug supervision departments of municipal and county-level people's governments with jurisdiction are responsible for drug supervision within their administrative regions. Relevant departments of local people's governments above the county level are responsible for drug-related supervision within their respective duties.
　　Article 9 Local people's governments above the county level are responsible for drug supervision within their administrative regions, uniformly leading, organizing, and coordinating drug supervision and emergency response to drug safety incidents, and establishing and improving drug supervision mechanisms and information sharing systems.
　　Article 10 Local people's governments above the county level shall incorporate drug safety work into their national economic and social development plans, include drug safety work funding in their government budgets, strengthen drug supervision capacity building, and provide guarantees for drug safety work.
　　Article 11 Drug supervision departments set up or designate professional drug technical institutions to undertake review, inspection, verification, monitoring, and evaluation work required by law for drug supervision.
　　Article 12 The state establishes and improves the drug traceability system. The drug supervision department of the State Council shall formulate unified drug traceability standards and norms, promote information interoperability and sharing, and achieve drug traceability.
　　The state establishes a pharmacovigilance system to monitor, identify, evaluate, and control adverse drug reactions and other harmful reactions related to drug use.
　　Article 13 People's governments at all levels and their relevant departments, drug industry associations, etc., shall strengthen drug safety publicity and education and carry out popularization of drug safety laws and regulations.
　　News media shall conduct public service publicity on drug safety laws and regulations and supervise drug-related illegal activities through public opinion. Drug-related publicity and reports shall be comprehensive, scientific, objective, and fair.
　　Article 14 Drug industry associations shall strengthen industry self-discipline, establish and improve industry norms, promote the construction of industry integrity systems, and guide and supervise members to carry out drug production and operation activities according to law.
　　Article 15 Local people's governments above the county level and their relevant departments shall commend and reward units and individuals who have made outstanding contributions in drug research, production, operation, use, and supervision according to national regulations.

Chapter 2 Drug Research and Registration

　　Article 16 The state supports drug innovation guided by clinical value and drugs with clear or special efficacy for human diseases, encourages the development of new drugs with new therapeutic mechanisms, treatment for life-threatening diseases or rare diseases, and multi-target systemic regulatory intervention functions, promoting technological progress in drugs.
　　The state encourages the use of modern science and technology and traditional Chinese medicine research methods to carry out scientific and technological research and drug development of traditional Chinese medicine, establish and improve technical evaluation systems suitable for the characteristics of traditional Chinese medicine, and promote the inheritance and innovation of traditional Chinese medicine.
　　The state takes effective measures to encourage the research and innovation of pediatric drugs, supports the development of new varieties, dosage forms, and specifications of pediatric drugs that meet children's physiological characteristics, and gives priority to the review and approval of pediatric drugs.
　　Article 17: Engaging in drug research and development activities shall comply with the Good Laboratory Practice for Non-clinical Studies of Drugs and Good Clinical Practice for Drugs, ensuring that the entire drug research and development process continuously meets legal requirements.
　　The Good Laboratory Practice for Non-clinical Studies of Drugs and Good Clinical Practice for Drugs are formulated by the drug regulatory department of the State Council in conjunction with relevant departments of the State Council.
　　Article 18: Conducting non-clinical drug research shall comply with relevant national regulations, have personnel, premises, equipment, instruments, and management systems appropriate to the research project, and ensure the authenticity of relevant data, materials, and samples.
　　Article 19: Conducting drug clinical trials shall truthfully submit relevant data, materials, and samples such as research methods, quality indicators, pharmacological and toxicological test results in accordance with the regulations of the drug regulatory department of the State Council, and obtain approval from the drug regulatory department of the State Council. The drug regulatory department of the State Council shall decide whether to agree and notify the clinical trial sponsor within sixty working days from the date of acceptance of the clinical trial application; if no notification is given after the deadline, it shall be deemed as consent. For bioequivalence trials, filing with the drug regulatory department of the State Council is required.
　　Drug clinical trials shall be conducted in clinical trial institutions with corresponding conditions. Drug clinical trial institutions are subject to filing management, and specific measures are jointly formulated by the drug regulatory department of the State Council and the health administration department of the State Council.
　　Article 20: Conducting drug clinical trials shall comply with ethical principles, formulate clinical trial protocols, and obtain approval from the ethics committee after review.
　　The ethics committee shall establish an ethical review work system to ensure that the ethical review process is independent, objective, and fair, supervise the standardized conduct of drug clinical trials, protect the legal rights and interests of subjects, and safeguard public interests.
　　Article 21: When implementing drug clinical trials, the purpose, risks, and other detailed information of the clinical trial shall be truthfully explained to the subjects or their guardians, informed consent shall be voluntarily signed by the subjects or their guardians, and effective measures shall be taken to protect the legal rights and interests of the subjects.
　　Article 22: During drug clinical trials, if safety issues or other risks are found, the clinical trial sponsor shall promptly adjust the clinical trial protocol, suspend or terminate the clinical trial, and report to the drug regulatory department of the State Council. If necessary, the drug regulatory department of the State Council may order adjustments to the clinical trial protocol, suspension, or termination of the clinical trial.
　　Article 23: For drugs under clinical trials used to treat diseases that seriously threaten life and have no effective treatment methods, if medical observation indicates possible benefits and ethical principles are met, after review and informed consent, they may be used within the clinical trial institution for other patients with the same condition.
　　Article 24: Drugs marketed within China shall be approved by the drug regulatory department of the State Council and obtain a drug registration certificate; however, Chinese medicinal materials and decoction pieces not subject to approval management are excluded. The catalog of Chinese medicinal materials and decoction pieces subject to approval management is formulated by the drug regulatory department of the State Council in conjunction with the traditional Chinese medicine administration department of the State Council.
　　Applications for drug registration shall provide true, sufficient, and reliable data, materials, and samples to prove the safety, efficacy, and quality controllability of the drug.
　　Article 25: For drugs applying for registration, the drug regulatory department of the State Council shall organize pharmaceutical, medical, and other technical personnel to conduct reviews, examine the safety, efficacy, and quality controllability of the drug, as well as the applicant's quality management, risk prevention, and liability compensation capabilities; if conditions are met, a drug registration certificate shall be issued.
　　When approving drugs, the drug regulatory department of the State Council shall review and approve chemical raw materials, related excipients, packaging materials and containers directly contacting the drug, and approve the drug's quality standards, production processes, labels, and instructions.
　　The excipients referred to in this law are the fillers and additives used in drug production and prescription formulation.
　　Article 26: For drugs treating diseases that seriously threaten life and have no effective treatment methods, as well as drugs urgently needed for public health, if clinical trial data show efficacy and can predict clinical value, conditional approval may be granted, and relevant matters shall be specified in the drug registration certificate.
　　Article 27: The drug regulatory department of the State Council shall improve the drug review and approval work system, strengthen capacity building, establish and improve communication, expert consultation, and other mechanisms, optimize the review and approval process, and improve review and approval efficiency.
　　The review conclusions and basis for approved marketed drugs shall be disclosed according to law and subject to social supervision. Commercial secrets known during the review and approval process shall be kept confidential.
　　Article 28: Drugs shall comply with national drug standards. For drug quality standards approved by the drug regulatory department of the State Council that are higher than national drug standards, the approved drug quality standards shall apply; if there are no national drug standards, the approved drug quality standards shall apply.
　　The "Pharmacopoeia of the People's Republic of China" and drug standards promulgated by the drug regulatory department of the State Council are national drug standards.
　　The drug regulatory department of the State Council, together with the health administration department of the State Council, organizes the Pharmacopoeia Committee responsible for the formulation and revision of national drug standards.
　　Drug testing institutions set up or designated by the drug regulatory department of the State Council are responsible for calibrating national drug standard substances and reference substances.
　　Article 29: The drug names included in the national drug standards are drug generic names. Names already used as drug generic names shall not be used as drug trademarks.

　 　Chapter 3 Drug Marketing Authorization Holder

　　Article 30: The drug marketing authorization holder refers to enterprises or drug research institutions that have obtained drug registration certificates.
　　The drug marketing authorization holder shall be responsible for non-clinical research, clinical trials, production and operation, post-marketing research, adverse reaction monitoring, reporting, and handling of drugs in accordance with this law. Other units and individuals engaged in drug research, production, operation, storage, transportation, and use shall bear corresponding responsibilities according to law.
　　The legal representative and principal responsible person of the drug marketing authorization holder are fully responsible for drug quality.
　　Article 31: The drug marketing authorization holder shall establish a drug quality assurance system and assign dedicated personnel independently responsible for drug quality management.
　　The drug marketing authorization holder shall regularly audit the quality management systems of entrusted drug manufacturing enterprises and drug operating enterprises, supervising their continuous capability for quality assurance and control.
　　Article 32: The drug marketing authorization holder may produce drugs by itself or entrust drug manufacturing enterprises to produce.
　　If the drug marketing authorization holder produces drugs by itself, it shall obtain a drug production license in accordance with this law; if entrusted for production, it shall entrust qualified drug manufacturing enterprises. The drug marketing authorization holder and the entrusted manufacturing enterprises shall sign entrustment and quality agreements and strictly perform the obligations agreed upon in the agreements.
　　The State Council's drug regulatory department formulates guidelines for drug contract manufacturing quality agreements to guide and supervise drug marketing authorization holders and contract manufacturing enterprises in fulfilling drug quality assurance obligations.
　　Blood products, narcotic drugs, psychotropic drugs, toxic medical drugs, and precursor chemicals for drug production shall not be contract manufactured; however, exceptions apply if otherwise stipulated by the State Council's drug regulatory department.
　　Article 33: Drug marketing authorization holders shall establish drug release procedures, review drugs released by manufacturing enterprises, and only release them after the quality authorized person signs. Drugs not meeting national drug standards shall not be released.
　　Article 34: Drug marketing authorization holders may sell drugs for which they have obtained registration certificates themselves or entrust drug distribution enterprises to sell. Those engaged in drug retail activities must obtain a drug business license.
　　Drug marketing authorization holders who sell drugs themselves must meet the conditions stipulated in Article 52 of this law; those who entrust sales must entrust qualified drug distribution enterprises. The marketing authorization holder and the entrusted enterprise shall sign an entrustment agreement and strictly fulfill the agreed obligations.
　　Article 35: Drug marketing authorization holders, drug manufacturing enterprises, and drug distribution enterprises that entrust storage and transportation of drugs shall assess the quality assurance and risk management capabilities of the entrusted party, sign an entrustment agreement specifying drug quality responsibilities and operating procedures, and supervise the entrusted party.
　　Article 36: Drug marketing authorization holders, drug manufacturing enterprises, drug distribution enterprises, and medical institutions shall establish and implement a drug traceability system, provide traceability information as required, and ensure drug traceability.
　　Article 37: Drug marketing authorization holders shall establish an annual reporting system and report drug production and sales, post-marketing research, risk management, and other situations to the drug regulatory departments of provincial, autonomous region, and municipal governments annually as prescribed.
　　Article 38: If the drug marketing authorization holder is a foreign enterprise, a designated legal entity within China shall fulfill the obligations of the marketing authorization holder and bear joint liability with the marketing authorization holder.
　　Article 39: Traditional Chinese medicine decoction piece manufacturing enterprises shall fulfill the relevant obligations of drug marketing authorization holders, implement full-process management of production and sales, establish a traceability system for decoction pieces, and ensure their safety, efficacy, and traceability.
　　Article 40: With approval from the State Council's drug regulatory department, drug marketing authorization holders may transfer drug marketing authorizations. The transferee shall have the capabilities for quality management, risk prevention, and liability compensation to ensure drug safety, efficacy, and quality control, and fulfill the obligations of the marketing authorization holder.

Chapter 4 Drug Production

　　Article 41: Engaging in drug manufacturing activities requires approval from the drug regulatory department of the provincial, autonomous region, or municipal government where located and obtaining a drug manufacturing license. Manufacturing drugs without a license is prohibited.
　　The drug manufacturing license shall indicate the validity period and production scope and be re-examined and reissued upon expiration.
　　Article 42: Engaging in drug manufacturing activities shall meet the following conditions:
　　(1) Have pharmaceutical technicians, engineering technicians, and corresponding technical workers qualified by law;
　　(2) Have factories, facilities, and sanitary environments suitable for drug manufacturing;
　　(3) Have institutions, personnel, and necessary instruments and equipment capable of quality management and quality inspection of produced drugs;
　　(4) Have regulations ensuring drug quality and comply with the drug manufacturing quality management standards formulated by the State Council's drug regulatory department according to this law.
　　Article 43: Engaging in drug manufacturing activities shall comply with drug manufacturing quality management standards, establish and improve drug manufacturing quality management systems, and ensure continuous compliance with legal requirements throughout the manufacturing process.
　　The legal representative and principal responsible person of the drug manufacturing enterprise are fully responsible for the drug manufacturing activities of their enterprise.
　　Article 44: Drugs shall be produced according to national drug standards and approved manufacturing processes by the drug regulatory department. Production and inspection records shall be complete and accurate and must not be fabricated.
　　Traditional Chinese medicine decoction pieces shall be processed according to national drug standards; if no national standards exist, they shall be processed according to processing standards formulated by the drug regulatory departments of provincial, autonomous region, or municipal governments. These processing standards shall be filed with the State Council's drug regulatory department. Decoction pieces not meeting national standards or not processed according to these standards shall not be released or sold.
　　Article 45: Raw materials and excipients required for drug production shall meet medicinal requirements and relevant drug manufacturing quality management standards.
　　Drug production shall audit suppliers of raw materials and excipients as prescribed to ensure purchased and used materials meet the above requirements.
　　Article 46: Packaging materials and containers directly contacting drugs shall meet medicinal requirements and standards ensuring human health and safety.
　　The drug regulatory department shall order the cessation of use of non-compliant packaging materials and containers directly contacting drugs.
　　Article 47: Drug manufacturing enterprises shall conduct quality inspections of drugs. Drugs not meeting national standards shall not be released.
　　Drug manufacturing enterprises shall establish drug release procedures, clarifying release standards and conditions. Drugs meeting standards and conditions may only be released after the quality authorized person signs.
　　Article 48: Drug packaging shall meet drug quality requirements and facilitate storage, transportation, and medical use.
　　Chinese medicinal materials in transit shall be packaged. Each package shall indicate the product name, origin, date, supplier, and bear a quality qualification mark.
　　Article 49: Drug packaging shall have labels printed or affixed and include instructions as prescribed.
　　Labels or instructions shall indicate the drug's generic name, ingredients, specifications, marketing authorization holder and address, manufacturing enterprise and address, approval number, product batch number, production date, expiration date, indications or main functions, usage, dosage, contraindications, adverse reactions, and precautions. Text on labels and instructions shall be clear, with production date, expiration date, and other information prominently marked and easily identifiable.
　　Labels and instructions for narcotic drugs, psychotropic drugs, toxic medical drugs, radioactive drugs, external-use drugs, and over-the-counter drugs shall bear prescribed marks.
　　Article 50: Holders of drug marketing authorization, drug manufacturing enterprises, drug distribution enterprises, and medical institutions' staff who directly contact drugs shall undergo health checks annually. Those suffering from infectious diseases or other diseases that may contaminate drugs shall not engage in work involving direct contact with drugs.

Chapter 5 Drug Operation

　　Article 51: Engaging in drug wholesale activities requires approval from the drug supervision and administration department of the provincial, autonomous region, or municipality government where located, and obtaining a drug business license. Engaging in drug retail activities requires approval from the drug supervision and administration department of the local people's government at or above the county level and obtaining a drug business license. Operating drugs without a drug business license is prohibited.
　　The drug business license shall indicate the validity period and scope of business and shall be re-examined and reissued upon expiration.
　　The drug supervision and administration department shall implement drug business licensing in accordance with the conditions stipulated in Article 52 of this law and shall also follow the principle of facilitating the public's access to medicines.
　　Article 52: The following conditions shall be met for engaging in drug business activities:
　　(1) Having pharmacists or other pharmaceutical technical personnel who have been qualified according to law;
　　(2) Having business premises, equipment, storage facilities, and sanitary environment suitable for the drugs operated;
　　(3) Having quality management institutions or personnel suitable for the drugs operated;
　　(4) Having rules and regulations to ensure drug quality and complying with the drug business quality management standards formulated by the State Council's drug supervision and administration department according to this law.
　　Article 53: Those engaged in drug business activities shall comply with drug business quality management standards, establish and improve the drug business quality management system, and ensure that the entire drug business process continuously meets legal requirements.
　　The state encourages and guides chain retail of drugs. The headquarters of enterprises engaged in drug retail chain operations shall establish a unified quality management system and fulfill management responsibilities for the business activities of their affiliated retail enterprises.
　　The legal representative and principal responsible person of a drug business enterprise shall be fully responsible for the drug business activities of the enterprise.
　　Article 54: The state implements a classification management system for prescription drugs and non-prescription drugs. Specific measures shall be formulated by the drug supervision and administration department of the State Council in conjunction with the health administration department of the State Council.
　　Article 55: Holders of drug marketing authorization, drug manufacturing enterprises, drug business enterprises, and medical institutions shall purchase drugs from holders of drug marketing authorization or enterprises qualified for drug production and operation; however, the purchase of Chinese medicinal materials not subject to approval management is excluded.
　　Article 56: Drug business enterprises purchasing drugs shall establish and implement an incoming inspection and acceptance system, verify drug qualification certificates and other labels; drugs that do not meet the requirements shall not be purchased or sold.
　　Article 57: Drug business enterprises purchasing and selling drugs shall have true and complete purchase and sales records. The records shall indicate the generic name, dosage form, specification, product batch number, expiration date, marketing authorization holder, manufacturer, purchasing and selling units, quantity, price, date, and other contents stipulated by the drug supervision and administration department of the State Council.
　　Article 58: Drug business enterprises retailing drugs shall be accurate and correct, and properly explain usage, dosage, and precautions; dispensing prescriptions shall be verified, and drugs listed in the prescription shall not be arbitrarily changed or substituted. Prescriptions with incompatibilities or overdoses shall be refused; if necessary, dispensing may proceed only after correction or re-signing by the prescribing physician.
　　Drug business enterprises selling Chinese medicinal materials shall indicate the place of origin.
　　Pharmacists or other pharmaceutical technical personnel who have been qualified according to law shall be responsible for the enterprise's drug management, prescription review and dispensing, and rational drug use guidance.
　　Article 59: Drug business enterprises shall formulate and implement drug storage systems and take necessary measures such as refrigeration, frost prevention, moisture prevention, insect prevention, and rodent prevention to ensure drug quality.
　　Drug warehousing and outbound procedures shall implement inspection systems.
　　Article 60: Urban and rural market trade markets may sell Chinese medicinal materials, except as otherwise stipulated by the State Council.
　　Article 61: Holders of drug marketing authorization and drug business enterprises selling drugs online shall comply with the relevant provisions of this law on drug business. Specific management measures shall be formulated by the drug supervision and administration department of the State Council in conjunction with the health administration department and other departments of the State Council.
　　Vaccines, blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, and precursor chemicals for drugs subject to special national management shall not be sold online.
　　Article 62: Third-party platform providers for drug online transactions shall file with the drug supervision and administration department of the provincial, autonomous region, or municipality government where they are located according to the regulations of the drug supervision and administration department of the State Council.
　　Third-party platform providers shall legally review the qualifications of holders of drug marketing authorization and drug business enterprises applying to operate on the platform to ensure compliance with legal requirements and manage drug business activities occurring on the platform.
　　If third-party platform providers discover that holders of drug marketing authorization or drug business enterprises operating on the platform violate the provisions of this law, they shall promptly stop such behavior and immediately report to the drug supervision and administration department of the local county-level people's government; if serious illegal acts are found, they shall immediately stop providing online transaction platform services.
　　Article 63: Newly discovered and imported medicinal materials from abroad may be sold only after approval by the drug supervision and administration department of the State Council.
　　Article 64: Drugs shall be imported through ports permitted for drug importation, and importing drug enterprises shall file with the drug supervision and administration department at the port location. Customs shall handle clearance procedures based on the import drug clearance certificate issued by the drug supervision and administration department. Customs shall not release drugs without the import drug clearance certificate.
　　The drug supervision and administration department at the port location shall notify drug inspection agencies to conduct spot checks and inspections of imported drugs according to the regulations of the drug supervision and administration department of the State Council.
　　Ports permitted for drug importation shall be proposed by the drug supervision and administration department of the State Council in conjunction with the General Administration of Customs and submitted to the State Council for approval.
　　Article 65: Medical institutions may import small quantities of drugs urgently needed for clinical use with approval from the drug supervision and administration department of the State Council or the people's government of the province, autonomous region, or municipality authorized by the State Council. Imported drugs shall be used within designated medical institutions for specific medical purposes.
　　Individuals carrying small quantities of drugs for personal use when entering the country shall handle procedures according to relevant national regulations.
　　Article 66: Import and export of narcotic drugs and psychotropic drugs within the scope prescribed by the state shall hold import and export permits issued by the drug supervision and administration department of the State Council.
　　Article 67: Importing drugs with uncertain efficacy, significant adverse reactions, or that endanger human health for other reasons is prohibited.
　　Article 68: The State Council's drug supervision and administration department shall designate drug inspection institutions to conduct inspections on the following drugs before sale or import; drugs that have not been inspected or have failed inspection shall not be sold or imported:
　　(1) Drugs sold for the first time within the territory of China;
　　(2) Biological products stipulated by the State Council's drug supervision and administration department;
　　(3) Other drugs stipulated by the State Council.

Chapter 6 Pharmaceutical Affairs Management in Medical Institutions

　　Article 69: Medical institutions shall be equipped with pharmacists or other pharmaceutical technical personnel who have been legally qualified, responsible for the management of drugs, prescription review and dispensing, and guidance on rational drug use within the unit. Non-pharmaceutical technical personnel shall not directly engage in pharmaceutical technical work.
　　Article 70: Medical institutions purchasing drugs shall establish and implement a system for inspection and acceptance of incoming goods, verifying drug qualification certificates and other labels; drugs that do not meet the requirements shall not be purchased or used.
　　Article 71: Medical institutions shall have premises, equipment, storage facilities, and sanitary environments suitable for the drugs used, establish and implement drug storage systems, and take necessary measures such as refrigeration, frost prevention, moisture prevention, pest control, and rodent prevention to ensure drug quality.
　　Article 72: Medical institutions shall adhere to the principles of safe, effective, economical, and rational drug use, follow clinical application guidelines, clinical diagnosis and treatment guidelines, and drug instructions for rational drug use, and review the appropriateness of physicians' prescriptions and medication orders.
　　Other drug-using units outside medical institutions shall comply with the provisions of this law regarding drug use in medical institutions.
　　Article 73: Pharmacists or other pharmaceutical technical personnel who have been legally qualified shall verify prescriptions when dispensing; drugs listed in the prescription shall not be arbitrarily changed or substituted. Prescriptions with incompatibilities or overdoses shall be refused; if necessary, dispensing may proceed only after correction or re-signing by the prescribing physician.
　　Article 74: Medical institutions preparing formulations shall obtain approval from the drug supervision and administration department of the people's government of the province, autonomous region, or municipality where they are located and obtain a medical institution formulation license. Formulations shall not be prepared without such a license.
　　The medical institution formulation license shall indicate the validity period and be re-examined and reissued upon expiration.
　　Article 75: Medical institutions preparing formulations shall have facilities, management systems, testing instruments, and sanitary environments that can ensure formulation quality.
　　Medical institutions preparing formulations shall follow the approved processes, and the required raw materials, excipients, and packaging materials shall meet pharmaceutical requirements.
　　Article 76: Formulations prepared by medical institutions shall be varieties needed clinically by the unit and not supplied 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 where they are located; however, except where laws provide otherwise for the preparation of traditional Chinese medicine formulations.
　　Formulations prepared by medical institutions shall undergo quality inspection as prescribed; qualified formulations may be used within the unit based on physician prescriptions. With approval from the State Council's drug supervision and administration department or the provincial, autonomous region, or municipal drug supervision and administration department, formulations prepared by medical institutions may be transferred and used among designated medical institutions.
　　Formulations prepared by medical institutions shall not be sold on the market.

Chapter 7 Post-Marketing Drug Management

　　Article 77: Drug marketing authorization holders shall develop post-marketing risk management plans, proactively conduct post-marketing studies, further confirm the safety, efficacy, and quality controllability of drugs, and strengthen continuous management of marketed drugs.
　　Article 78: For conditionally approved drugs, drug marketing authorization holders shall take corresponding risk management measures and complete related studies within the prescribed time limits as required; if studies are not completed on time or benefits cannot be proven to outweigh risks, the State Council's drug supervision and administration department shall handle the matter according to law, up to and including revoking the drug registration certificate.
　　Article 79: Changes in the drug production process shall be managed by classification according to their impact on drug safety, efficacy, and quality controllability. Major changes shall be approved by the State Council's drug supervision and administration department; other changes shall be filed or reported according to the department's regulations.
　　Drug marketing authorization holders shall comprehensively assess and verify the impact of changes on drug safety, efficacy, and quality controllability according to the regulations of the State Council's drug supervision and administration department.
　　Article 80: Drug marketing authorization holders shall conduct post-marketing adverse reaction monitoring, actively collect and track suspected adverse drug reaction information, and promptly take risk control measures for identified risks.
　　Article 81: Drug marketing authorization holders, drug manufacturers, drug distributors, and medical institutions shall regularly investigate the quality, efficacy, and adverse reactions of drugs they produce, operate, or use. Suspected adverse reactions shall be promptly reported to the drug supervision and administration department and health authorities. Specific measures shall be formulated by the State Council's drug supervision and administration department in conjunction with the State Council's health authorities.
　　For drugs confirmed to have caused serious adverse reactions, the State Council's drug supervision and administration department or the drug supervision and administration department of the people's government of the province, autonomous region, or municipality shall take emergency control measures such as stopping production, sales, or use based on actual circumstances, organize an appraisal within five days, and make an administrative decision within fifteen days from the conclusion of the appraisal according to law.
　　Article 82: If drugs have quality problems or other safety hazards, drug marketing authorization holders shall immediately stop sales, notify relevant drug distributors and medical institutions to stop sales and use, recall sold drugs, promptly disclose recall information, and if necessary, immediately stop production. They shall report the recall and handling situation to the drug supervision and administration department and health authorities of the province, autonomous region, or municipality. Drug manufacturers, distributors, and medical institutions shall cooperate.
　　If drug marketing authorization holders fail to recall drugs as required by law, the drug supervision and administration department of the province, autonomous region, or municipality shall order them to recall.
　　Article 83: Drug marketing authorization holders shall regularly conduct post-marketing evaluations of the safety, efficacy, and quality controllability of marketed drugs. When necessary, the State Council's drug supervision and administration department may order drug marketing authorization holders to conduct post-marketing evaluations or directly organize such evaluations.
　　After evaluation, drugs with uncertain efficacy, significant adverse reactions, or other reasons harmful to human health shall have their drug registration certificates revoked.
　　Drugs with revoked drug registration certificates shall not be produced, imported, sold, or used.
　　Drugs with revoked drug registration certificates, expired validity, or other conditions shall be supervised for destruction or other harmless treatment measures by the drug supervision and administration department according to law.

Chapter 8 Drug Pricing and Advertising

　　Article 84: The state shall improve the drug procurement management system, monitor drug prices, conduct cost price investigations, strengthen supervision and inspection of drug prices, investigate and deal with illegal drug price activities such as price monopoly and price gouging according to law, and maintain the order of drug prices.
　　Article 85: For drugs subject to market-regulated prices according to law, the drug marketing authorization holders, drug manufacturers, drug distributors, and medical institutions shall set prices based on the principles of fairness, reasonableness, good faith, and consistency between quality and price, providing reasonably priced drugs to users.
　　Drug marketing authorization holders, drug manufacturers, drug distributors, and medical institutions shall comply with the regulations of the State Council's drug price authorities on drug price management, formulate and mark retail drug prices, and prohibit profiteering, price monopoly, and price fraud.
　　Article 86: Drug marketing authorization holders, drug manufacturers, drug distributors, and medical institutions shall lawfully provide the drug price authorities with information on the actual purchase and sale prices and quantities of their drugs.
　　Article 87: Medical institutions shall provide patients with a price list of the drugs used and truthfully disclose the prices of commonly used drugs as prescribed, strengthening the management of rational drug use. Specific measures shall be formulated by the health authorities of the State Council.
　　Article 88: It is prohibited for drug marketing authorization holders, drug manufacturers, drug distributors, and medical institutions to give or receive kickbacks or other improper benefits in drug purchase and sale.
　　It is prohibited for drug marketing authorization holders, drug manufacturers, drug distributors, or agents to give property or other improper benefits to persons in charge of medical institutions using their drugs, drug procurement personnel, physicians, pharmacists, and other related personnel under any name. It is also prohibited for persons in charge of medical institutions, drug procurement personnel, physicians, pharmacists, and other related personnel to receive property or other improper benefits from drug marketing authorization holders, drug manufacturers, drug distributors, or agents under any name.
　　Article 89: Drug advertisements must be approved by the advertising review authority designated by the people's government of the province, autonomous region, or municipality where the advertiser is located; advertisements not approved shall not be published.
　　Article 90: The content of drug advertisements shall be truthful and lawful, based on the drug instructions approved by the drug regulatory department of the State Council, and shall not contain false content.
　　Drug advertisements shall not contain assertions or guarantees regarding efficacy or safety; they shall not use the name or image of state organs, research institutions, academic institutions, industry associations, experts, scholars, physicians, pharmacists, patients, or others for recommendation or endorsement.
　　Non-drug advertisements shall not contain promotion related to drugs.
　　Article 91: For drug prices and advertisements not stipulated in this law, the provisions of the "Price Law of the People's Republic of China," "Anti-Monopoly Law of the People's Republic of China," "Anti-Unfair Competition Law of the People's Republic of China," "Advertising Law of the People's Republic of China," and other laws shall apply.

Chapter 9 Drug Reserves and Supply

　　Article 92: The state implements a drug reserve system, establishing central and local two-level drug reserves.
　　In the event of major disasters, epidemics, or other emergencies, drugs may be urgently mobilized in accordance with the "Emergency Response Law of the People's Republic of China."
　　Article 93: The state implements a basic drug system, selecting an appropriate number of basic drug varieties, strengthening organized production and reserves, improving the supply capacity of basic drugs, and meeting the basic drug needs for disease prevention and treatment.
　　Article 94: The state establishes a drug supply and demand monitoring system, promptly collecting, summarizing, and analyzing information on the supply and demand of shortage drugs, issuing early warnings for shortage drugs, and taking response measures.
　　Article 95: The state implements a shortage drug list management system. Specific measures shall be formulated by the health authorities of the State Council in conjunction with the drug regulatory departments and other departments of the State Council.
　　Drug marketing authorization holders who stop producing shortage drugs shall report to the drug regulatory department of the State Council or the drug regulatory department of the people's government of the province, autonomous region, or municipality according to regulations.
　　Article 96: The state encourages the research and production of shortage drugs, giving priority review and approval to new drugs urgently needed clinically, drugs for the prevention and treatment of major infectious diseases, rare diseases, and other diseases.
　　Article 97: For shortage drugs, the State Council may restrict or prohibit exports. When necessary, relevant departments of the State Council may take measures such as organizing production, price intervention, and expanding imports to ensure drug supply.
　　Drug marketing authorization holders, drug manufacturers, and drug distributors shall ensure drug production and supply according to regulations.

Chapter 10 Supervision and Administration

　　Article 98: It is prohibited to produce (including preparation, the same below), sell, or use counterfeit or substandard drugs.
　　The following circumstances constitute counterfeit drugs:
　　(1) The ingredients contained in the drug do not conform to the ingredients specified in the national drug standards;
　　(2) Pretending non-drugs as drugs or pretending other types of drugs as this drug;
　　(3) Deteriorated drugs;
　　(4) The indications or main functions marked on the drug exceed the prescribed scope.
　　The following circumstances constitute substandard drugs:
　　(1) The content of drug ingredients does not meet national drug standards;
　　(2) Contaminated drugs;
　　(3) Drugs without marked or with altered expiration dates;
　　(4) Drugs without marked or with altered product batch numbers;
　　(5) Drugs past their expiration date;
　　(6) Drugs with unauthorized addition of preservatives or excipients;
　　(7) Other drugs that do not meet drug standards.
　　It is prohibited to produce or import drugs without obtaining drug approval documents; it is prohibited to use raw materials, packaging materials, and containers that have not been reviewed and approved according to regulations to produce drugs.
　　Article 99: Drug regulatory departments shall supervise and inspect activities such as drug research and development, production, operation, and drug use by drug-using units in accordance with laws and regulations. When necessary, they may extend inspections to units and individuals providing products or services for drug research, production, operation, and use. Relevant units and individuals shall cooperate and shall not refuse or conceal.
　　Drug regulatory departments shall implement key supervision and inspection on high-risk drugs.
　　For evidence indicating possible safety hazards, drug regulatory departments shall, based on supervision and inspection results, take measures such as warnings, interviews, rectification within a time limit, suspension of production, sales, use, import, etc., and promptly announce the inspection and handling results.
　　When the drug supervision and administration department conducts supervision and inspection, it shall present proof documents and keep confidential any trade secrets learned during the supervision and inspection.
　　Article 100: The drug supervision and administration department may conduct spot checks and inspections on drug quality as needed for supervision and management. Spot checks and inspections shall be conducted according to prescribed sampling methods and no fees shall be charged; samples shall be purchased. The required expenses shall be budgeted according to the regulations of the State Council.
　　For drugs and related materials with evidence proving potential harm to human health, the drug supervision and administration department may seal and seize them and make an administrative decision within seven days; if the drugs require inspection, an administrative decision shall be made within fifteen days from the issuance of the inspection report.
　　Article 101: The drug supervision and administration departments of the State Council and the people's governments of provinces, autonomous regions, and municipalities directly under the central government shall regularly announce the results of drug quality spot checks and inspections; if the announcement is inappropriate, corrections shall be made within the original announcement scope.
　　Article 102: If a party has objections to the drug inspection results, they may apply for re-inspection within seven days from receiving the drug inspection results to the original drug inspection institution or a drug inspection institution set up or designated by the higher-level drug supervision and administration department, or directly to a drug inspection institution set up or designated by the State Council's drug supervision and administration department. The drug inspection institution accepting the re-inspection shall make a re-inspection conclusion within the time prescribed by the State Council's drug supervision and administration department.
　　Article 103: The drug supervision and administration department shall inspect the compliance of drug marketing authorization holders, drug manufacturing enterprises, drug operating enterprises, non-clinical safety evaluation research institutions, clinical trial institutions, and others with Good Manufacturing Practice for drugs, Good Supply Practice for drugs, Good Laboratory Practice for non-clinical research, Good Clinical Practice for clinical trials, and supervise their continuous compliance with legal requirements.
　　Article 104: The state shall establish a professional and specialized team of drug inspectors. Inspectors shall be familiar with drug laws and regulations and possess professional knowledge of drugs.
　　Article 105: The drug supervision and administration department shall establish drug safety credit files for drug marketing authorization holders, drug manufacturing enterprises, drug operating enterprises, non-clinical safety evaluation research institutions, clinical trial institutions, and medical institutions, recording license issuance, routine supervision and inspection results, violations handling, and other situations, publicly disclose them according to law, and update them in a timely manner; for those with poor credit records, increase the frequency of supervision and inspection and may implement joint disciplinary actions according to national regulations.
　　Article 106: The drug supervision and administration department shall publish its email address and telephone number to accept consultations, complaints, and reports, and respond, verify, and handle them in a timely manner according to law. For verified reports, rewards shall be given to the informants according to relevant regulations.
　　The drug supervision and administration department shall keep the informant's information confidential and protect the informant's legal rights and interests. If the informant reports their unit, the unit shall not retaliate against the informant by terminating, changing the labor contract, or other means.
　　Article 107: The state implements a unified drug safety information disclosure system. The overall national drug safety situation, drug safety risk warning information, major drug safety incidents and their investigation and handling information, and other information designated by the State Council for unified disclosure shall be published by the drug supervision and administration department of the State Council. If the impact of drug safety risk warning information and major drug safety incidents and their investigation and handling information is limited to specific regions, it may also be published by the drug supervision and administration departments of the people's governments of the relevant provinces, autonomous regions, or municipalities directly under the central government. Unauthorized release of the above information is prohibited.
　　The disclosure of drug safety information shall be timely, accurate, comprehensive, and include necessary explanations to avoid misleading.
　　No unit or individual shall fabricate or spread false drug safety information.
　　Article 108: People's governments at or above the county level shall formulate emergency plans for drug safety incidents. Drug marketing authorization holders, drug manufacturing enterprises, drug operating enterprises, and medical institutions shall formulate their own drug safety incident response plans and organize training and emergency drills.
　　When a drug safety incident occurs, people's governments at or above the county level shall immediately organize response work according to the emergency plan; relevant units shall immediately take effective measures to handle the situation and prevent further harm.
　　Article 109: If the drug supervision and administration department fails to timely detect systemic drug safety risks or eliminate drug safety hazards within the supervision area, the people's government at the same level or the higher-level drug supervision and administration department shall interview its main responsible persons.
　　If local people's governments fail to fulfill drug safety responsibilities or fail to timely eliminate major regional drug safety hazards, the higher-level people's government or the higher-level drug supervision and administration department shall interview their main responsible persons.
　　The interviewed departments and local people's governments shall immediately take measures to rectify drug supervision and administration work.
The interview and rectification situations shall be included in the evaluation and assessment records of drug supervision and administration work of relevant departments and local people's governments.
　　Article 110: Local people's governments and their drug supervision and administration departments shall not restrict or exclude drugs produced by drug marketing authorization holders or drug manufacturing enterprises from other regions from entering their region by requiring drug inspection, approval, or other means.
　　Article 111: The drug supervision and administration department and its set up or designated professional drug technical institutions shall not participate in drug production and operation activities, nor recommend, supervise, or monitor drugs in their name.
　　Staff of the drug supervision and administration department and its set up or designated professional drug technical institutions shall not participate in drug production and operation activities.
　　Article 112: The State Council shall have other special management provisions for narcotic drugs, psychotropic drugs, toxic medical drugs, radioactive drugs, precursor chemicals for drugs, and others, which shall be followed accordingly.
　　Article 113: If the drug supervision and administration department discovers drug violations suspected of criminal offenses, it shall promptly transfer the case to the public security authorities.
　　For cases that do not require criminal responsibility or are exempt from criminal punishment according to law but require administrative responsibility, the public security authorities, people's procuratorates, and people's courts shall promptly transfer the case to the drug supervision and administration department.
　　When the public security authorities, people's procuratorates, and people's courts request the drug supervision and administration department, ecological environment authorities, and other departments to provide inspection conclusions, identification opinions, and assistance in harmless disposal of involved drugs, the relevant departments shall provide timely assistance.

Chapter 11 Legal Liability

　　Article 114: Violations of this law constituting a crime shall be investigated for criminal responsibility according to law.
　　Article 115: Those who produce or sell drugs without obtaining a drug production license, drug operation license, or medical institution preparation license shall be ordered to close, have the illegally produced or sold drugs and illegal gains confiscated, and be fined between fifteen and thirty times the value of the illegally produced or sold drugs (including both sold and unsold drugs); if the value is less than 100,000 yuan, it shall be calculated as 100,000 yuan.
　　Article 116: For the production and sale of counterfeit drugs, confiscate the illegally produced and sold drugs and illegal gains, order suspension of production and business rectification, revoke the drug approval certificate, and impose a fine of no less than fifteen times and no more than thirty times the value of the illegally produced and sold drugs; if the value is less than 100,000 yuan, it shall be calculated as 100,000 yuan; in serious cases, revoke the drug production license, drug business license, or medical institution preparation license, and do not accept their corresponding applications within ten years; if the drug marketing authorization holder is a foreign enterprise, prohibit the import of its drugs for ten years.
　　Article 117: For the production and sale of inferior drugs, confiscate the illegally produced and sold drugs and illegal gains, and impose a fine of no less than ten times and no more than twenty times the value of the illegally produced and sold drugs; if the value of illegally produced or wholesaled drugs is less than 100,000 yuan, it shall be calculated as 100,000 yuan; if the value of illegally retailed drugs is less than 10,000 yuan, it shall be calculated as 10,000 yuan; in serious cases, order suspension of production and business rectification until revocation of the drug approval certificate, drug production license, drug business license, or medical institution preparation license.
　　If the produced and sold Chinese herbal pieces do not meet drug standards but do not affect safety and efficacy, order correction within a time limit and issue a warning; a fine of no less than 100,000 yuan and no more than 500,000 yuan may be imposed.
　　Article 118: For the production and sale of counterfeit drugs, or the production and sale of inferior drugs with serious circumstances, confiscate the income obtained by the legal representative, main responsible person, directly responsible supervisor, and other responsible personnel during the illegal acts, impose a fine of no less than 30% and no more than three times the income obtained, ban them from engaging in drug production and business activities for life, and may be detained by public security authorities for no less than five days and no more than fifteen days.
　　Confiscate raw materials, excipients, packaging materials, and production equipment specifically used by producers for manufacturing counterfeit or inferior drugs.
　　Article 119: If drug-using units use counterfeit or inferior drugs, they shall be punished according to the provisions for selling counterfeit drugs and retailing inferior drugs; in serious cases, if the legal representative, main responsible person, directly responsible supervisor, and other responsible personnel hold medical and health personnel practice certificates, their practice certificates shall also be revoked.
　　Article 120: Those who know or should know that the drugs belong to counterfeit or inferior drugs or drugs specified in items one to five of paragraph one of Article 124 of this law, and provide storage, transportation, or other facilitation conditions, shall have all storage and transportation income confiscated and be fined no less than one time and no more than five times the illegal income; in serious cases, a fine of no less than five times and no more than fifteen times the illegal income shall be imposed; if the illegal income is less than 50,000 yuan, it shall be calculated as 50,000 yuan.
　　Article 121: The penalty decision for counterfeit and inferior drugs shall legally state the quality inspection conclusion of the drug inspection agency.
　　Article 122: Forging, altering, renting, lending, or illegally buying and selling licenses or drug approval certificates shall result in confiscation of illegal gains and a fine of no less than one time and no more than five times the illegal gains; in serious cases, a fine of no less than five times and no more than fifteen times the illegal gains shall be imposed, the drug production license, drug business license, medical institution preparation license, or drug approval certificate shall be revoked, and the legal representative, main responsible person, directly responsible supervisor, and other responsible personnel shall be fined no less than 20,000 yuan and no more than 200,000 yuan, be banned from engaging in drug production and business activities for ten years, and may be detained by public security authorities for no less than five days and no more than fifteen days; if the illegal gains are less than 100,000 yuan, it shall be calculated as 100,000 yuan.
　　Article 123: Providing false certificates, data, materials, samples, or using other means to fraudulently obtain clinical trial permits, drug production permits, drug business permits, medical institution preparation permits, or drug registration and other permits shall result in revocation of the relevant permits, refusal to accept corresponding applications for ten years, and a fine of no less than 500,000 yuan and no more than 5,000,000 yuan; in serious cases, the legal representative, main responsible person, directly responsible supervisor, and other responsible personnel shall be fined no less than 20,000 yuan and no more than 200,000 yuan, be banned from engaging in drug production and business activities for ten years, and may be detained by public security authorities for no less than five days and no more than fifteen days.
　　Article 124: Violating the provisions of this law with any of the following acts shall result in confiscation of illegally produced, imported, and sold drugs and illegal gains, as well as raw materials, excipients, packaging materials, and production equipment specifically used for illegal production, order suspension of production and business rectification, and impose a fine of no less than fifteen times and no more than thirty times the value of the illegally produced, imported, and sold drugs; if the value is less than 100,000 yuan, it shall be calculated as 100,000 yuan; in serious cases, revoke the drug approval certificate up to revoking the drug production license, drug business license, or medical institution preparation license; confiscate the income obtained by the legal representative, main responsible person, directly responsible supervisor, and other responsible personnel during the illegal acts, impose a fine of no less than 30% and no more than three times the income obtained, ban them from engaging in drug production and business activities for ten years up to life, and may be detained by public security authorities for no less than five days and no more than fifteen days:
　　(1) Producing or importing drugs without obtaining a drug approval certificate;
　　(2) Producing or importing drugs using drug approval certificates obtained by deceptive means;
　　(3) Producing drugs using active pharmaceutical ingredients that have not been reviewed and approved;
　　(4) Selling drugs that should be inspected but have not been inspected;
　　(5) Producing or selling drugs prohibited by the State Council's drug regulatory department;
　　(6) Fabricating production or inspection records;
　　(7) Making major changes in the drug production process without approval.
　　Selling drugs specified in items one to three of the preceding paragraph, or drug-using units using drugs specified in items one to five of the preceding paragraph, shall be punished according to the preceding paragraph; in serious cases, if the legal representative, main responsible person, directly responsible supervisor, and other responsible personnel of the drug-using unit hold medical and health personnel practice certificates, their practice certificates shall also be revoked.
　　Importing a small amount of legally marketed foreign drugs without approval, if the circumstances are minor, may be mitigated or exempted from punishment according to law.
　　Article 125: Violating the provisions of this law with any of the following acts shall result in confiscation of illegally produced and sold drugs and illegal gains, as well as packaging materials and containers, order suspension of production and business rectification, and impose a fine of no less than 500,000 yuan and no more than 5,000,000 yuan; in serious cases, revoke the drug approval certificate, drug production license, and drug business license; the legal representative, main responsible person, directly responsible supervisor, and other responsible personnel shall be fined no less than 20,000 yuan and no more than 200,000 yuan, and be banned from engaging in drug production and business activities for ten years up to life:
　　(1) Conducting drug clinical trials without approval;
　　(2) Using packaging materials or containers that have not been reviewed and approved and directly contact drugs to produce drugs, or selling such drugs;
　　(3) Using unapproved labels or instructions.
　　Article 126 Except as otherwise provided in this Law, if the drug marketing authorization holder, drug manufacturing enterprise, drug distribution enterprise, non-clinical drug safety evaluation research institution, clinical trial institution, etc., fail to comply with the drug production quality management standards, drug distribution quality management standards, non-clinical research quality management standards, clinical trial quality management standards, etc., they shall be ordered to make corrections within a time limit and given a warning; if they fail to make corrections within the time limit, a fine of not less than 100,000 yuan but not more than 500,000 yuan shall be imposed; if the circumstances are serious, a fine of not less than 500,000 yuan but not more than 2,000,000 yuan shall be imposed, and they shall be ordered to suspend production and business for rectification or have their drug approval documents, drug production licenses, drug distribution licenses, etc., revoked. Non-clinical drug safety evaluation research institutions and clinical trial institutions shall not conduct non-clinical drug safety evaluation research or clinical trials for five years. The legal representatives, main responsible persons, directly responsible supervisors, and other responsible personnel shall have the income obtained from the illegal acts confiscated and be fined between 10% and 50% of the income obtained. They shall be prohibited from engaging in drug production and distribution activities for ten years up to a lifetime.
　　Article 127 Whoever violates the provisions of this Law by any of the following acts shall be ordered to make corrections within a time limit and given a warning; if they fail to make corrections within the time limit, a fine of not less than 100,000 yuan but not more than 500,000 yuan shall be imposed:
　　(1) Conducting bioequivalence tests without filing;
　　(2) During drug clinical trials, if safety issues or other risks are found, and the clinical trial sponsor fails to promptly adjust the clinical trial plan, suspend or terminate the clinical trial, or fails to report to the State Council drug regulatory department;
　　(3) Failure to establish and implement a drug traceability system as required;
　　(4) Failure to submit annual reports as required;
　　(5) Failure to file or report changes in the drug production process as required;
　　(6) Failure to formulate a post-marketing risk management plan for drugs;
　　(7) Failure to conduct post-marketing research or post-marketing evaluation of drugs as required.
　　Article 128 Except for cases where counterfeit or inferior drugs should be punished according to law, if drug packaging does not have labels printed or affixed, or instructions attached as required, or if the labels or instructions do not indicate relevant information or required marks as prescribed, correction shall be ordered and a warning given; if the circumstances are serious, the drug registration certificate shall be revoked.
　　Article 129 Whoever violates the provisions of this Law by the drug marketing authorization holder, drug manufacturing enterprise, drug distribution enterprise, or medical institution not purchasing drugs from the drug marketing authorization holder or enterprises qualified for drug production and distribution shall be ordered to make corrections, have the illegally purchased drugs and illegal gains confiscated, and be fined not less than twice but not more than ten times the value of the illegally purchased drugs; if the circumstances are serious, a fine of not less than ten times but not more than thirty times the value shall be imposed, and the drug approval documents, drug production license, drug distribution license, or medical institution practice license shall be revoked; if the value is less than 50,000 yuan, it shall be calculated as 50,000 yuan.
　　Article 130 Whoever violates the provisions of this Law by drug distribution enterprises failing to record drug purchase and sales as required, retail drugs without correct instructions on usage and dosage, or failing to dispense prescriptions as required shall be ordered to make corrections and given a warning; if the circumstances are serious, the drug distribution license shall be revoked.
　　Article 131 Whoever violates the provisions of this Law by third-party platforms providing drug online trading services failing to perform qualification review, reporting, or stopping the provision of online trading platform services shall be ordered to make corrections, have illegal gains confiscated, and be fined not less than 200,000 yuan but not more than 2,000,000 yuan; if the circumstances are serious, they shall be ordered to suspend business for rectification and be fined not less than 2,000,000 yuan but not more than 5,000,000 yuan.
　　Article 132 Imported drugs that have obtained drug registration certificates but fail to file with the drug regulatory department at the port of entry as required shall be ordered to make corrections within a time limit and given a warning; if they fail to make corrections within the time limit, the drug registration certificate shall be revoked.
　　Article 133 Whoever violates the provisions of this Law by medical institutions selling their prepared formulations on the market shall be ordered to make corrections, have the illegally sold formulations and illegal gains confiscated, and be fined not less than twice but not more than five times the value of the illegally sold formulations; if the circumstances are serious, a fine of not less than five times but not more than fifteen times the value shall be imposed; if the value is less than 50,000 yuan, it shall be calculated as 50,000 yuan.
　　Article 134 If the drug marketing authorization holder fails to conduct adverse drug reaction monitoring or report suspected adverse drug reactions as required, they shall be ordered to make corrections within a time limit and given a warning; if they fail to make corrections within the time limit, they shall be ordered to suspend production and business for rectification and be fined not less than 100,000 yuan but not more than 1,000,000 yuan.
　　If drug distribution enterprises fail to report suspected adverse drug reactions as required, they shall be ordered to make corrections within a time limit and given a warning; if they fail to make corrections within the time limit, they shall be ordered to suspend production and business for rectification and be fined not less than 50,000 yuan but not more than 500,000 yuan.
　　If medical institutions fail to report suspected adverse drug reactions as required, they shall be ordered to make corrections within a time limit and given a warning; if they fail to make corrections within the time limit, they shall be fined not less than 50,000 yuan but not more than 500,000 yuan.
　　Article 135 If the drug marketing authorization holder refuses to recall after being ordered to do so by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government, a fine of not less than five times but not more than ten times the value of the drugs to be recalled shall be imposed; if the value is less than 100,000 yuan, it shall be calculated as 100,000 yuan; if the circumstances are serious, the drug approval documents, drug production license, and drug distribution license shall be revoked, and the legal representative, main responsible persons, directly responsible supervisors, and other responsible personnel shall be fined not less than 20,000 yuan but not more than 200,000 yuan. Drug manufacturing enterprises, drug distribution enterprises, and medical institutions refusing to cooperate with the recall shall be fined not less than 100,000 yuan but not more than 500,000 yuan.
　　Article 136 If the drug marketing authorization holder is a foreign enterprise, and its designated domestic enterprise legal person fails to perform relevant obligations in accordance with this Law, the provisions on the legal responsibilities of drug marketing authorization holders in this Law shall apply.
　　Article 137 Whoever commits any of the following acts shall be punished more severely within the penalty range prescribed by this Law:
　　(1) Passing off narcotic drugs, psychotropic drugs, toxic medical drugs, radioactive drugs, or precursor chemicals as other drugs, or passing off other drugs as the aforementioned drugs;
　　(2) Producing or selling counterfeit or inferior drugs mainly used by pregnant women and children;
　　(3) Producing or selling biological products that are counterfeit or inferior drugs;
　　(4) Producing or selling counterfeit or inferior drugs causing personal injury;
　　(5) Producing or selling counterfeit or inferior drugs and reoffending after being dealt with;
　　(6) Refusing or evading supervision and inspection, forging, destroying, concealing relevant evidence materials, or unauthorized use of sealed or confiscated 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 unit shall be fined not less than 200,000 yuan and not more than 1 million yuan; the directly responsible supervisors and other directly responsible personnel shall be demoted, dismissed, or expelled according to law, illegal gains shall be confiscated, and a fine of not more than 50,000 yuan shall be imposed; if the circumstances are serious, their testing qualification shall be revoked. If the inspection results issued by the drug testing institution are untrue and cause losses, corresponding compensation liability shall be borne.
　　Article 139: The administrative penalties stipulated in Articles 115 to 138 of this law shall be decided by the drug supervision and administration departments of the people's governments at or above the county level according to their division of responsibilities; the revocation of licenses and cancellation of permits shall be decided by the original approving and issuing departments.
　　Article 140: If the drug marketing authorization holders, drug manufacturing enterprises, drug operating enterprises, or medical institutions violate the provisions of this law in employing personnel, the drug supervision and administration department or the health administrative department shall order dismissal and impose a fine of not less than 50,000 yuan and not more than 200,000 yuan.
　　Article 141: If drug marketing authorization holders, drug manufacturing enterprises, drug operating enterprises, or medical institutions give or receive kickbacks or other improper benefits in drug purchase and sales, and if drug marketing authorization holders, drug manufacturing enterprises, drug operating enterprises, or agents give property or other improper benefits to the heads of medical institutions using their drugs, drug procurement personnel, physicians, pharmacists, and other related personnel, the market supervision department shall confiscate illegal gains and impose a fine of not less than 300,000 yuan and not more than 3 million yuan; if the circumstances are serious, the business licenses of the drug marketing authorization holders, drug manufacturing enterprises, and drug operating enterprises shall be revoked, and the drug supervision and administration department shall revoke the drug approval certificates, drug production licenses, and drug operation licenses.
　　If drug marketing authorization holders, drug manufacturing enterprises, or drug operating enterprises bribe state staff during drug research, production, or operation, the legal representatives, main responsible persons, directly responsible supervisors, and other responsible personnel shall be banned for life from engaging in drug production and operation activities.
　　Article 142: If the heads, procurement personnel, and other related personnel of drug marketing authorization holders, drug manufacturing enterprises, or drug operating enterprises accept property or other improper benefits from other drug marketing authorization holders, drug manufacturing enterprises, drug operating enterprises, or agents during drug purchase and sales, illegal gains shall be confiscated and penalties imposed according to law; if the circumstances are serious, they shall be prohibited from engaging in drug production and operation activities for five years.
　　If the heads of medical institutions, drug procurement personnel, physicians, pharmacists, and other related personnel accept property or other improper benefits from drug marketing authorization holders, drug manufacturing enterprises, drug operating enterprises, or agents, the health administrative department or their own unit shall impose disciplinary actions and confiscate illegal gains; if the circumstances are serious, their practice certificates shall also be revoked.
　　Article 143: Violating the provisions of this law by fabricating or spreading false drug safety information, constituting a violation of public security management, shall be punished by the public security organs according to law.
　　Article 144: If drug marketing authorization holders, drug manufacturing enterprises, drug operating enterprises, or medical institutions violate the provisions of this law and cause harm to drug users, they shall bear compensation liability according to law.
　　If damage is caused by drug quality issues, the victim may request compensation for losses from the drug marketing authorization holders or drug manufacturing enterprises, or from drug operating enterprises or medical institutions. Upon receiving the victim's compensation request, the first liable party shall implement primary responsibility and make advance compensation; after advance compensation, they may seek legal recourse.
　　Producing counterfeit or inferior drugs or knowingly selling or using counterfeit or inferior drugs, the victim or their close relatives may request compensation for losses and also request payment of ten times the price or three times the loss as compensation; if the increased compensation amount is less than 1,000 yuan, it shall be 1,000 yuan.
　　Article 145: If the drug supervision and administration department or its established or designated professional drug technical institutions participate in drug production and operation activities, their superior authorities shall order corrections and confiscate illegal income; if the circumstances are serious, the directly responsible supervisors and other directly responsible personnel shall be punished according to law.
　　If staff of the drug supervision and administration department or its established or designated drug professional technical institutions participate in drug production and operation activities, they shall be punished according to law.
　　Article 146: If the drug supervision and administration department or its established or designated drug testing institutions illegally charge inspection fees during drug supervision and inspection, the relevant government departments shall order refunds, and the directly responsible supervisors and other directly responsible personnel shall be punished according to law; if the circumstances are serious, their testing qualifications shall be revoked.
　　Article 147: If the drug supervision and administration department violates the provisions of this law with any of the following acts, the relevant licenses shall be revoked, and the directly responsible supervisors and other directly responsible personnel shall be punished according to law:
　　(1) Approving drug clinical trials without meeting the conditions;
　　(2) Issuing drug registration certificates to drugs that do not meet the conditions;
　　(3) Issuing drug production licenses, drug operation licenses, or medical institution preparation licenses to units that do not meet the conditions.
　　Article 148: If the people's governments at or above the county level violate the provisions of this law with any of the following acts, the directly responsible supervisors and other directly responsible personnel shall be given demerit or major demerit punishments; if the circumstances are serious, they shall be demoted, dismissed, or expelled:
　　(1) Concealing, falsely reporting, delaying reporting, or omitting reports of drug safety incidents;
　　(2) Failing to promptly eliminate regional major drug safety hazards, causing particularly major drug safety incidents within the administrative region, or continuous major drug safety incidents;
　　(3) Neglecting duties, causing serious adverse effects or major losses.
　　Article 149: If the drug supervision and other departments violate the provisions of this law with any of the following acts, the directly responsible supervisors and other directly responsible personnel shall be given demerit or major demerit punishments; if the circumstances are relatively serious, they shall be demoted or dismissed; if the circumstances are serious, they shall be expelled:
　　(1) Concealing, falsely reporting, delaying reporting, or omitting reports of drug safety incidents;
　　(2) Failing to promptly investigate and handle discovered drug safety violations;
　　(3) Failing to promptly identify systemic drug safety risks or failing to promptly eliminate drug safety hazards within the supervision area, causing serious impact;
　　(4) Other failures to perform drug supervision duties, causing serious adverse effects or major losses.
　　Article 150: Drug supervision personnel who abuse their power, engage in favoritism or dereliction of duty shall be punished according to law.
If there is dereliction of duty or negligence in investigating and handling counterfeit or inferior drug violations, the directly responsible supervisors and other directly responsible personnel of the drug supervision department shall be severely punished according to law.
　　Article 151 The value of goods stipulated in this chapter shall be calculated based on the marked price of illegally produced or sold drugs; if there is no marked price, it shall be calculated according to the market price of similar drugs.

Chapter 12 Supplementary Provisions

　　Article 152 The management of the planting, collection, and breeding of Chinese medicinal materials shall be carried out in accordance with relevant laws and regulations.
　　Article 153 The management measures for regionally commonly used folk medicinal materials shall be formulated by the drug supervision department of the State Council in conjunction with the traditional Chinese medicine authority of the State Council.
　　Article 154 The specific measures for the implementation of this law by the People's Liberation Army and the 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 effect on December 1, 2019. 月1日起施行。