Source: National People's Congress of China

(Adopted at the 7th Meeting of the Standing Committee of the Sixth National People's Congress on September 20, 1984; First Amendment according to the Decision on Amending Seven Laws Including the Law of the People's Republic of China on the Protection of the Marine Environment adopted at the 20th Meeting of the Standing Committee of the Ninth National People's Congress on February 28, 2001; First Revision based on the Decision of the Standing Committee of the 12th National People's Congress on Amending the Law of the People's Republic of China on the Protection of the Marine Environment and other seven laws on December 28, 2013; Second Revision based on the Decision of the Standing Committee of the 12th National People's Congress on Amending the Drug Administration Law of the People's Republic of China on April 24, 2015; Second Amendment on August 26, 2019 at the 12th Meeting of the Standing Committee of the 13th National People's Congress)

　　　　Contents
Chapter 1 General Provisions
Chapter 2 Drug Research and Registration
Chapter 3 Marketing Authorization Holders of Drugs
Chapter 4 Drug Production
Chapter 5 Drug Distribution
Chapter 6 Pharmaceutical Management in Medical Institutions
Chapter 7 Post-Market Drug Management
Chapter 8 Drug Price and Advertisement
Chapter 9 Drug Reserve and Supply
Chapter 10 Supervision and Management
Chapter 11 Legal Liabilities
Chapter 12 Supplementary Provisions

Chapter 1 General Provisions

　　Article 1 This Law is formulated to strengthen drug management, ensure drug quality, protect public interests in safe and legal drug use, and protect and promote public health.
　　Article 2 This Law applies to activities related to drug research, production, operation, use, and supervision and management within the territory of the People's Republic of China.
　　For the purpose of this Law, "drugs" refer to substances used to prevent, treat, or diagnose human diseases, to purposefully adjust human physiological functions, and with specified indications, functions, usage, and dosage, including traditional Chinese medicine, chemical drugs, and biological products.
　　Article 3 Drug management shall center on people's health, adhere to the principles of risk management, full-process control, and social governance, establish a scientific and rigorous supervision and management system, comprehensively improve drug quality, and ensure the safety, effectiveness, and accessibility of drugs.
　　Article 4 The state shall develop modern and traditional medicine, giving full play to their roles in disease prevention, medical treatment, and health care.
The state shall protect wild medicinal material resources and Chinese medicinal varieties and encourage the cultivation of authentic Chinese medicinal materials.
　　Article 5 The state encourages research and development of new drugs and protects the legitimate rights and interests of citizens, legal persons, and other organizations in researching and developing new drugs.
　　Article 6 The state implements a marketing authorization holder system for drug management. Marketing authorization holders are legally responsible for the safety, efficacy, and quality controllability of drugs throughout the entire process of drug research, production, operation, and use.
　　Article 7 Those engaged in drug research, production, operation, and use activities 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 Drug Administration under the State Council is responsible for national drug supervision and management. Relevant departments under the State Council are responsible for drug-related supervision and management within their respective jurisdictions. The State Drug Administration cooperates with relevant departments under the State Council in implementing national drug industry development plans and industrial policies.
　　The drug supervision and management departments of the provincial, autonomous regional, and municipal people's governments are responsible for drug supervision and management within their respective administrative regions. The departments (hereinafter referred to as drug supervision and management departments) of prefecture-level and county-level people's governments that undertake drug supervision and management responsibilities are responsible for drug supervision and management within their respective administrative regions. Relevant departments of county-level and above local people's governments are responsible for drug-related supervision and management within their respective jurisdictions.
　　Article 9 County-level and above local people's governments are responsible for drug supervision and management within their administrative regions, and unify the leadership, organization, and coordination of drug supervision and management as well as response to drug safety emergencies within their administrative regions, establishing sound drug supervision and management mechanisms and information-sharing mechanisms.
　　Article 10 County-level and above people's governments shall include drug safety work in their national economic and social development plans, include drug safety funds in their government budgets, strengthen drug supervision and management capacity building, and provide guarantees for drug safety work.
　　Article 11 Drug supervision and management departments shall set up or designate specialized drug technical institutions to undertake the review, testing, verification, monitoring, and evaluation work required for the lawful implementation of drug supervision and management.
　　Article 12 The state shall establish and improve a drug traceability system. The State Drug Administration under the State Council shall formulate unified drug traceability standards and norms, promote the interoperability and sharing of drug traceability information, and achieve drug traceability.
　　The state shall establish a pharmacovigilance system to monitor, identify, assess, and control adverse drug reactions and other harmful reactions related to drug use.
　　Article 13 All levels of people's governments and their relevant departments, drug industry associations, etc., shall strengthen drug safety publicity and education, and popularize knowledge of drug safety laws, regulations, etc.
　　News media shall conduct public service publicity on drug safety laws, regulations, etc., and conduct public opinion supervision over illegal drug activities. Relevant reports on drugs 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 an industry credit system, and guide and urge members to engage in drug production and operation activities in accordance with the law.
　　Article 15 County-level and above people's governments and their relevant departments shall commend and reward units and individuals who have made outstanding contributions to drug research, production, operation, use, and supervision and management work in accordance with relevant national regulations.

Chapter 2 Drug Research and Registration

　　Article 16 The state supports drug innovation that is clinically valuable and has a clear or special therapeutic effect on human diseases, encourages the research and development of new drugs with new therapeutic mechanisms, treating serious life-threatening diseases or rare diseases, and having multi-target systemic regulatory intervention functions, and promotes the progress of drug technology.
　　The state encourages the use of modern science and technology and traditional Chinese medicine research methods to conduct scientific and technological research and drug development of traditional Chinese medicine, establishes and improves a technical evaluation system that conforms to the characteristics of traditional Chinese medicine, and promotes the inheritance and innovation of traditional Chinese medicine.
　　The state shall take effective measures to encourage the research and development and innovation of pediatric drugs, support the development of new varieties, dosage forms, and specifications of pediatric drugs that meet the physiological characteristics of children, and give priority to the review and approval of pediatric drugs.
　　Article 17 Those engaged in drug research and development activities shall comply with the Good Laboratory Practice for Non-clinical Drug Studies and Good Clinical Practice, ensuring that the entire process of drug research consistently meets legal requirements.
　　Good quality management specifications for non-clinical drug research and clinical drug trials are formulated by the State Council's drug supervision and administration department in conjunction with relevant departments of the State Council.
　　Article 18 The conduct of non-clinical drug research shall comply with relevant national regulations; it shall have personnel, venues, equipment, instruments, and management systems commensurate with the research project to ensure the authenticity of relevant data, materials, and samples.
　　Article 19 The conduct of clinical drug trials shall, in accordance with the regulations of the State Council's drug supervision and administration department, truthfully submit relevant data, materials, and samples such as research methods, quality indicators, and pharmacological and toxicological test results, subject to approval by the State Council's drug supervision and administration department. The State Council's drug supervision and administration department shall decide whether to approve or disapprove the application within sixty working days of receiving the application for a clinical trial and notify the applicant; if notification is not given within the specified time limit, it shall be deemed as consent. In the case of conducting bioequivalence tests, they shall be filed with the State Council's drug supervision and administration department.
　　Clinical drug trials shall be conducted at clinical trial institutions that have the corresponding conditions. Clinical drug trial institutions are subject to filing management; the specific methods are to be formulated jointly by the State Council's drug supervision and administration department and the State Council's health and health administration department.
　　Article 20 The conduct of clinical drug trials shall comply with ethical principles, and a clinical trial plan shall be formulated and approved by the ethics committee.
　　The ethics committee shall establish an ethical review system to ensure that the ethical review process is independent, objective, and fair, to supervise the standardized conduct of clinical drug trials, to safeguard the legitimate rights and interests of subjects, and to uphold the public interest.
　　Article 21 In the implementation of clinical drug trials, the purpose and risks of the clinical trial shall be truthfully explained to the subject or his or her guardian, and an informed consent form voluntarily signed by the subject or his or her guardian shall be obtained; effective measures shall also be taken to protect the legitimate rights and interests of the subject.
　　Article 22 During clinical drug trials, if safety issues or other risks are found, the clinical trial applicant shall promptly adjust the clinical trial plan, suspend or terminate the clinical trial, and report to the State Council's drug supervision and administration department. If necessary, the State Council's drug supervision and administration department may order the adjustment of the clinical trial plan, or the suspension or termination of the clinical trial.
　　Article 23 For drugs currently undergoing clinical trials for the treatment of diseases that seriously endanger life and for which there are no effective treatment methods, if medical observation indicates that benefits may be obtained and ethical principles are complied with, after review and informed consent, they may be used for other patients with the same condition within the institutions conducting the clinical trials.
　　Article 24 Drugs marketed within China shall be approved by the State Council's drug supervision and administration department and obtain a drug registration certificate; however, this excludes Chinese medicinal materials and Chinese medicinal preparations that are not subject to approval management. The catalog of Chinese medicinal materials and Chinese medicinal preparations subject to approval management is formulated by the State Council's drug supervision and administration department in conjunction with the State Council's department in charge of traditional Chinese medicine.
　　Applications for drug registration shall provide true, sufficient, and reliable data, materials, and samples to prove the safety, effectiveness, and quality controllability of the drugs.
　　Article 25 For drugs whose registration is applied for, the State Council's drug supervision and administration department shall organize pharmacists, physicians, and other technical personnel to conduct evaluations, review the safety, effectiveness, and quality controllability of the drugs, as well as the applicant's quality management, risk control, and compensation capacity; if the conditions are met, a drug registration certificate shall be issued.
　　When approving drugs, the State Council's drug supervision and administration department shall conduct joint reviews and approvals of chemical raw materials, conduct joint reviews of relevant excipients, packaging materials, and containers that are in direct contact with the drugs, and jointly approve the quality standards, production processes, labels, and instructions for the drugs.
　　Excipients, as referred to in this Law, mean excipients and additives used in the production of drugs and in the preparation of prescriptions.
　　Article 26 For drugs for the treatment of diseases that seriously endanger life and for which there are no effective treatment methods, and for drugs urgently needed in public health, if clinical trial data shows efficacy and can predict their clinical value, conditional approval may be granted, and relevant matters shall be stated in the drug registration certificate.
　　Article 27 The State Council's drug supervision and administration department shall improve the drug review and approval system, strengthen capacity building, establish and improve communication, expert consultation, and other mechanisms, optimize the review and approval process, and improve the efficiency of review and approval.
　　The review conclusions and basis for approval of marketed drugs shall be made public in accordance with the law and be subject to public supervision. Commercial secrets learned during the review and approval process shall be kept confidential.
　　Article 28 Drugs shall comply with national drug standards. If the drug quality standards approved by the State Council's drug supervision and administration department are higher than the national drug standards, the approved drug quality standards shall be followed; if there are no national drug standards, the approved drug quality standards shall be followed.
　　The "Pharmacopoeia of the People's Republic of China" and drug standards promulgated by the State Council's drug supervision and administration department are national drug standards.
　　The State Council's drug supervision and administration department, in conjunction with the State Council's health and health administration department, shall organize the pharmacopoeia committee to be responsible for the formulation and revision of national drug standards.
　　Drug testing institutions established or designated by the State Council's drug supervision and administration department are responsible for the standardization of national drug reference standards and control substances.
　　Article 29 The drug names included in the national drug standards are generic drug names. Once a name is used as a generic drug name, that name may not be used as a drug trademark.

　 　Chapter 3 Marketing Authorization Holders of Drugs

　　Article 30 A drug marketing authorization holder refers to an enterprise or drug research institution that has obtained a drug registration certificate.
　　Drug marketing authorization holders shall, in accordance with the provisions of this Law, bear responsibility for non-clinical research, clinical trials, production and operation, post-market research, adverse reaction monitoring and reporting and handling, etc. Other units and individuals engaged in drug research, production, operation, storage, transportation, and use shall bear the corresponding responsibilities according to law.
　　The legal representative and principal person in charge of the drug marketing authorization holder shall bear overall responsibility for drug quality.
　　Article 31 Drug marketing authorization holders shall establish a drug quality assurance system and equip specialized personnel to independently manage drug quality.
　　Drug marketing authorization holders shall conduct regular audits of the quality management systems of entrusted drug production enterprises and drug distribution enterprises, and supervise their continued possession of quality assurance and control capabilities.
　　Article 32 Drug marketing authorization holders may produce drugs themselves or entrust drug production enterprises to do so.
　　If drug marketing authorization holders produce drugs themselves, they shall obtain drug production licenses in accordance with the provisions of this Law; if they entrust others to produce, they shall entrust qualified drug production enterprises. Drug marketing authorization holders and entrusted production enterprises shall sign entrustment agreements and quality agreements and strictly fulfill the obligations stipulated in the agreements.
　　The State Council's drug supervision and administration department formulates guidelines for the quality agreements for entrusted drug production to guide and supervise drug marketing authorization holders and entrusted production enterprises in fulfilling their drug quality assurance obligations.
　　Blood products, narcotic drugs, psychotropic drugs, medical poisonous drugs, and drug-related easily manufactured chemical substances may not be entrusted for production; however, this does not apply if otherwise stipulated by the State Council's drug supervision and administration department.
　　Article 33 The drug marketing authorization holder shall establish a drug marketing release procedure, review the drugs released from the factory by the drug manufacturer, and only release them after the quality authorized person signs. Those that do not meet national drug standards shall not be released.
　　Article 34 The drug marketing authorization holder may sell the drugs for which it has obtained a drug registration certificate on its own, or it may entrust drug business enterprises to sell them. Drug marketing authorization holders engaged in drug retail activities shall obtain a drug business license.
　　If the drug marketing authorization holder sells drugs on its own, it shall meet the conditions stipulated in Article 52 of this Law; if it entrusts sales, it shall entrust qualified drug business enterprises. The drug marketing authorization holder and the entrusted business enterprise shall sign an entrustment agreement and strictly fulfill the obligations stipulated in the agreement.
　　Article 35 When drug marketing authorization holders, drug manufacturers, and drug business enterprises entrust the storage and transportation of drugs, they shall assess the quality assurance capacity and risk management capacity of the entrusted party, sign an entrustment agreement with it, stipulate the content of drug quality responsibility and operating procedures, and supervise the entrusted party.
　　Article 36 Drug marketing authorization holders, drug manufacturers, drug business enterprises, and medical institutions shall establish and implement a drug traceability system, provide traceability information as prescribed, and ensure that drugs are traceable.
　　Article 37 The drug marketing authorization holder shall establish an annual reporting system and report the situation of drug production and sales, post-marketing research, and risk management to the drug supervision and administration department of the provincial, autonomous region, and municipality directly under the Central Government as prescribed each year.
　　Article 38 If the drug marketing authorization holder is a foreign enterprise, the corporate legal person designated by it within China shall perform the obligations of the drug marketing authorization holder and shall bear joint and several liability with the drug marketing authorization holder.
　　Article 39 Traditional Chinese medicine (TCM) slice production enterprises shall fulfill the relevant obligations of the drug marketing authorization holder, implement full-process management of TCM slice production and sales, establish a TCM slice traceability system, and ensure the safety, effectiveness, and traceability of TCM slices.
　　Article 40 With the approval of the State Council's drug supervision and administration department, the drug marketing authorization holder may transfer the drug marketing authorization. The transferee shall have the quality management, risk prevention and control, and liability compensation capabilities to ensure the safety, effectiveness, and controllable quality of the drug, and shall fulfill the obligations of the drug marketing authorization holder.

Chapter 4 Drug Production

　　Article 41 Those engaged in drug production activities shall obtain a drug production license after approval by the drug supervision and administration department of the provincial, autonomous region, or municipality directly under the Central Government. Drugs may not be produced without a drug production license.
　　The drug production license shall indicate the validity period and production scope, and re-examination and issuance shall be conducted upon expiry.
　　Article 42 Those engaged in drug production activities shall meet the following conditions:
　　(1) Pharmaceutical technicians, engineering technicians, and corresponding skilled workers who have been legally qualified;
　　(2) Factory buildings, facilities, and sanitary environment suitable for drug production;
　　(3) Institutions, personnel, and necessary instruments and equipment capable of conducting quality management and quality inspection of the produced drugs;
　　(4) Rules and regulations to ensure drug quality, and meet the requirements of the Good Manufacturing Practice for Drugs formulated by the State Council's drug supervision and administration department in accordance with this Law.
　　Article 43 Those engaged in drug production activities shall comply with the Good Manufacturing Practice for Drugs, establish and improve the drug production quality management system, and ensure that the entire drug production process continuously meets legal requirements.
　　The legal representative and main person in charge of the drug manufacturing enterprise shall be fully responsible for the drug production activities of the enterprise.
　　Article 44 Drugs shall be produced in accordance with national drug standards and production processes approved by the drug supervision and administration department. Production and inspection records shall be complete and accurate, and shall not be fabricated.
　　TCM slices shall be processed in accordance with national drug standards; where not stipulated in national drug standards, they shall be processed in accordance with the processing specifications formulated by the drug supervision and administration department of the provincial, autonomous region, or municipality directly under the Central Government. The processing specifications formulated by the drug supervision and administration department of the provincial, autonomous region, or municipality directly under the Central Government shall be filed with the State Council's drug supervision and administration department. Those that do not meet national drug standards or are not processed in accordance with the processing specifications formulated by the drug supervision and administration department of the provincial, autonomous region, or municipality directly under the Central Government shall not be allowed to leave the factory or be sold.
　　Article 45 Raw materials and excipients required for drug production shall meet pharmaceutical requirements and the relevant requirements of the Good Manufacturing Practice for Drugs.
　　In drug production, suppliers of raw materials and excipients shall be audited as prescribed to ensure that the purchased and used raw materials and excipients meet the requirements of the preceding paragraph.
　　Article 46 Packaging materials and containers that directly contact drugs shall meet pharmaceutical requirements and standards that ensure human health and safety.
　　Non-compliant packaging materials and containers that directly contact drugs shall be ordered to stop use by the drug supervision and administration department.
　　Article 47 Drug manufacturers shall conduct quality inspections of drugs. Those that do not meet national drug standards shall not be allowed to leave the factory.
　　Drug manufacturers shall establish drug factory release procedures, clarifying the standards and conditions for factory release. Those that meet the standards and conditions may be released after being signed by the quality authorized person.
　　Article 48 Drug packaging shall meet the requirements of drug quality and facilitate storage, transportation, and medical use.
　　The shipment of Chinese herbal medicines shall be packaged. Each package shall indicate the name, origin, date, and supplier, and shall be accompanied by a quality assurance mark.
　　Article 49 Drug packaging shall be printed or affixed with labels and accompanied by instructions as prescribed.
　　The label or instructions shall indicate the generic name, ingredients, specification, marketing authorization holder and its address, manufacturer and its address, approval number, product batch number, production date, expiration date, indications or functions and main treatments, usage, dosage, contraindications, adverse reactions, and precautions. The text in the label and instructions shall be clear, and items such as production date and expiration date shall be prominently marked and easily identifiable.
　　Labels and instructions for narcotic drugs, psychotropic drugs, medical poisonous drugs, radioactive drugs, external use drugs, and over-the-counter drugs shall be printed with prescribed marks.
　　Article 50 Personnel directly contacting drugs in drug marketing authorization holders, drug manufacturers, drug business enterprises, and medical institutions shall undergo annual health checks. Those with infectious diseases or other diseases that may contaminate drugs shall not engage in work that directly contacts drugs.

Chapter 5 Drug Distribution

　　Article 51: Engaging in pharmaceutical wholesale activities requires approval from the drug supervision and administration department of the provincial, autonomous region, or municipal people's government and obtaining a pharmaceutical business license. Engaging in pharmaceutical retail activities requires approval from the drug supervision and administration department of the county-level or above local people's government and obtaining a pharmaceutical business license. No pharmaceuticals may be sold without a pharmaceutical business license.
　　The pharmaceutical business license should specify the validity period and business scope. The license will be re-examined and issued upon expiry.
　　In implementing pharmaceutical business licensing, the drug supervision and administration departments, in addition to the conditions stipulated in Article 52 of this Law, should also follow the principle of facilitating public access to medicines.
　　Article 52: Engaging in pharmaceutical business activities requires the following conditions:
　　(1) Having a pharmacist or other pharmaceutical technician who has been legally qualified and certified;
　　(2) Having business premises, equipment, warehousing facilities, and a hygienic environment suitable for the pharmaceuticals being handled;
　　(3) Having a quality management institution or personnel suitable for the pharmaceuticals being handled;
　　(4) Having regulations and systems that guarantee the quality of pharmaceuticals and meet the requirements of pharmaceutical business quality management specifications formulated by the State Council's drug supervision and administration department in accordance with this Law.
　　Article 53: Those engaged in pharmaceutical business activities shall comply with pharmaceutical business quality management specifications, establish and improve a pharmaceutical business quality management system, and ensure that the entire pharmaceutical business process continuously meets legal requirements.
　　The state encourages and guides chain operations of pharmaceutical retail businesses. The headquarters of enterprises engaged in pharmaceutical retail chain operations shall establish a unified quality management system and assume management responsibility for the business activities of their affiliated retail enterprises.
　　The legal representative and principal person in charge of a pharmaceutical business enterprise shall be fully responsible for the pharmaceutical business activities of the enterprise.
　　Article 54: The state implements a classification management system for prescription drugs and non-prescription drugs. The specific methods shall be formulated by the State Council's drug supervision and administration department in conjunction with the State Council's health and health administrative department.
　　The drug listing applicant, drug production enterprise, drug business enterprise, and medical institution shall purchase drugs from the drug listing applicant or an enterprise with drug production or business qualifications; however, this does not include the purchase of Chinese medicinal materials that are not subject to approval management.
　　Article 56: Pharmaceutical business enterprises shall establish and implement an incoming goods inspection and acceptance system when purchasing pharmaceuticals, verifying the pharmaceutical qualification certificate and other markings; those that do not meet the specified requirements shall not be purchased or sold.
　　Article 57: Pharmaceutical business enterprises shall keep accurate and complete purchase and sales records for pharmaceuticals. The purchase and sales records shall indicate the generic name, dosage form, specification, product batch number, expiration date, marketing authorization holder, manufacturer, purchaser and seller, quantity, price, date of purchase and sale, and other information specified by the State Council's drug supervision and administration department.
　　Article 58: Pharmaceutical business enterprises shall accurately dispense retail pharmaceuticals and correctly explain the usage, dosage, and precautions; prescription dispensing shall be verified, and the pharmaceuticals listed in the prescription shall not be arbitrarily altered or substituted. Prescriptions with incompatible ingredients or excessive doses shall be refused; if necessary, the prescription may be dispensed only after correction or re-signing by the prescribing physician.
　　Pharmaceutical business enterprises selling Chinese medicinal materials shall indicate the origin.
　　A legally qualified pharmacist or other pharmaceutical technician shall be responsible for the management of pharmaceuticals, prescription review and dispensing, and rational drug use guidance in the enterprise.
　　Article 59: Pharmaceutical business enterprises shall formulate and implement pharmaceutical storage regulations, and take necessary measures such as refrigeration, frost protection, moisture protection, insect protection, and rodent protection to ensure pharmaceutical quality.
　　Inspection procedures shall be followed for the entry and exit of pharmaceuticals from warehouses.
　　Article 60: Rural and urban market trade markets may sell Chinese medicinal materials, except as otherwise provided by the State Council.
　　Article 61: Drug listing applicants and pharmaceutical business enterprises selling drugs online shall comply with the relevant provisions of this Law on pharmaceutical business. The specific management measures shall be formulated by the State Council's drug supervision and administration department in conjunction with the State Council's health and health administrative department and other departments.
　　Vaccines, blood products, narcotic drugs, psychotropic drugs, medical toxic drugs, radioactive drugs, and drug-like easily manufactured chemical substances and other pharmaceuticals under special state control may not be sold online.
　　Article 62: Providers of third-party platforms for pharmaceutical online transactions shall, in accordance with the regulations of the State Council's drug supervision and administration department, register with the drug supervision and administration department of the provincial, autonomous region, or municipal people's government where they are located.
　　Third-party platform providers shall, in accordance with the law, audit the qualifications of drug listing applicants and pharmaceutical business enterprises applying to conduct business on the platform, ensure that they meet the legal requirements, and manage pharmaceutical business activities that occur on the platform.
　　If a third-party platform provider finds that a drug listing applicant or pharmaceutical business enterprise conducting business on the platform has violated the provisions of this Law, it shall promptly stop such behavior and immediately report it to the drug supervision and administration department of the county-level people's government where it is located; if a serious violation of the law is found, it shall immediately cease providing online transaction platform services.
　　Article 63: Newly discovered and imported medicinal materials from abroad may be sold only after approval by the State Council's drug supervision and administration department.
　　Article 64: Pharmaceuticals shall be imported from ports that permit the import of pharmaceuticals, and enterprises importing pharmaceuticals shall register with the drug supervision and administration department at the location of the port. Customs shall handle customs clearance procedures with the import pharmaceutical customs clearance document issued by the drug supervision and administration department. Customs shall not release pharmaceuticals without an import pharmaceutical customs clearance document.
　　The drug supervision and administration department at the port of entry shall notify the pharmaceutical testing institution to conduct spot checks and tests of imported pharmaceuticals in accordance with the regulations of the State Council's drug supervision and administration department.
　　Ports that permit the import of pharmaceuticals shall be proposed by the State Council's drug supervision and administration department in conjunction with the General Administration of Customs and submitted to the State Council for approval.
　　Article 65: Medical institutions that need to import a small amount of pharmaceuticals due to urgent clinical needs may import them after approval by the State Council's drug supervision and administration department or the provincial, autonomous region, or municipal people's government authorized by the State Council. Imported pharmaceuticals shall be used for specific medical purposes within designated medical institutions.
　　Individuals may bring in small quantities of pharmaceuticals for their own use in accordance with relevant national regulations.
　　Article 66: The import and export of narcotic drugs and psychotropic drugs within the scope specified by the state shall have an import permit and export permit issued by the State Council's drug supervision and administration department.
　　Article 67: The import of pharmaceuticals with uncertain efficacy, significant adverse reactions, or other reasons that endanger human health is prohibited.
　　Article 68: The State Council's drug supervision and administration department shall designate a pharmaceutical testing institution to inspect the following pharmaceuticals before sale or import; those that have not been tested or fail the test may not be sold or imported:
　　(1) Pharmaceuticals sold in China for the first time;
　　（二）国务院药品监督管理部门规定的生物制品；
　　（三）国务院规定的其他药品。

Chapter 6 Pharmaceutical Management in Medical Institutions

　　第六十九条　医疗机构应当配备依法经过资格认定的药师或者其他药学技术人员，负责本单位的药品管理、处方审核和调配、合理用药指导等工作。非药学技术人员不得直接从事药剂技术工作。
　　第七十条　医疗机构购进药品，应当建立并执行进货检查验收制度，验明药品合格证明和其他标识；不符合规定要求的，不得购进和使用。
　　第七十一条　医疗机构应当有与所使用药品相适应的场所、设备、仓储设施和卫生环境，制定和执行药品保管制度，采取必要的冷藏、防冻、防潮、防虫、防鼠等措施，保证药品质量。
　　第七十二条　医疗机构应当坚持安全有效、经济合理的用药原则，遵循药品临床应用指导原则、临床诊疗指南和药品说明书等合理用药，对医师处方、用药医嘱的适宜性进行审核。
　　医疗机构以外的其他药品使用单位，应当遵守本法有关医疗机构使用药品的规定。
　　第七十三条　依法经过资格认定的药师或者其他药学技术人员调配处方，应当进行核对，对处方所列药品不得擅自更改或者代用。对有配伍禁忌或者超剂量的处方，应当拒绝调配；必要时，经处方医师更正或者重新签字，方可调配。
　　第七十四条　医疗机构配制制剂，应当经所在地省、自治区、直辖市人民政府药品监督管理部门批准，取得医疗机构制剂许可证。无医疗机构制剂许可证的，不得配制制剂。
　　医疗机构制剂许可证应当标明有效期，到期重新审查发证。
　　第七十五条　医疗机构配制制剂，应当有能够保证制剂质量的设施、管理制度、检验仪器和卫生环境。
　　医疗机构配制制剂，应当按照经核准的工艺进行，所需的原料、辅料和包装材料等应当符合药用要求。
　　第七十六条　医疗机构配制的制剂，应当是本单位临床需要而市场上没有供应的品种，并应当经所在地省、自治区、直辖市人民政府药品监督管理部门批准；但是，法律对配制中药制剂另有规定的除外。
　　医疗机构配制的制剂应当按照规定进行质量检验；合格的，凭医师处方在本单位使用。经国务院药品监督管理部门或者省、自治区、直辖市人民政府药品监督管理部门批准，医疗机构配制的制剂可以在指定的医疗机构之间调剂使用。
　　医疗机构配制的制剂不得在市场上销售。

Chapter 7 Post-Market Drug Management

　　第七十七条　药品上市许可持有人应当制定药品上市后风险管理计划，主动开展药品上市后研究，对药品的安全性、有效性和质量可控性进行进一步确证，加强对已上市药品的持续管理。
　　第七十八条　对附条件批准的药品，药品上市许可持有人应当采取相应风险管理措施，并在规定期限内按照要求完成相关研究；逾期未按照要求完成研究或者不能证明其获益大于风险的，国务院药品监督管理部门应当依法处理，直至注销药品注册证书。
　　第七十九条　对药品生产过程中的变更，按照其对药品安全性、有效性和质量可控性的风险和产生影响的程度，实行分类管理。属于重大变更的，应当经国务院药品监督管理部门批准，其他变更应当按照国务院药品监督管理部门的规定备案或者报告。
　　药品上市许可持有人应当按照国务院药品监督管理部门的规定，全面评估、验证变更事项对药品安全性、有效性和质量可控性的影响。
　　第八十条　药品上市许可持有人应当开展药品上市后不良反应监测，主动收集、跟踪分析疑似药品不良反应信息，对已识别风险的药品及时采取风险控制措施。
　　第八十一条　药品上市许可持有人、药品生产企业、药品经营企业和医疗机构应当经常考察本单位所生产、经营、使用的药品质量、疗效和不良反应。发现疑似不良反应的，应当及时向药品监督管理部门和卫生健康主管部门报告。具体办法由国务院药品监督管理部门会同国务院卫生健康主管部门制定。
　　对已确认发生严重不良反应的药品，由国务院药品监督管理部门或者省、自治区、直辖市人民政府药品监督管理部门根据实际情况采取停止生产、销售、使用等紧急控制措施，并应当在五日内组织鉴定，自鉴定结论作出之日起十五日内依法作出行政处理决定。
　　第八十二条　药品存在质量问题或者其他安全隐患的，药品上市许可持有人应当立即停止销售，告知相关药品经营企业和医疗机构停止销售和使用，召回已销售的药品，及时公开召回信息，必要时应当立即停止生产，并将药品召回和处理情况向省、自治区、直辖市人民政府药品监督管理部门和卫生健康主管部门报告。药品生产企业、药品经营企业和医疗机构应当配合。
　　药品上市许可持有人依法应当召回药品而未召回的，省、自治区、直辖市人民政府药品监督管理部门应当责令其召回。
　　第八十三条　药品上市许可持有人应当对已上市药品的安全性、有效性和质量可控性定期开展上市后评价。必要时，国务院药品监督管理部门可以责令药品上市许可持有人开展上市后评价或者直接组织开展上市后评价。
　　经评价，对疗效不确切、不良反应大或者因其他原因危害人体健康的药品，应当注销药品注册证书。
　　已被注销药品注册证书的药品，不得生产或者进口、销售和使用。
　　已被注销药品注册证书、超过有效期等的药品，应当由药品监督管理部门监督销毁或者依法采取其他无害化处理等措施。

Chapter 8 Drug Price and Advertisement

　　第八十四条　国家完善药品采购管理制度，对药品价格进行监测，开展成本价格调查，加强药品价格监督检查，依法查处价格垄断、哄抬价格等药品价格违法行为，维护药品价格秩序。
　　Article 85. For drugs whose prices are subject to market regulation in accordance with the law, the drug marketing authorization holders, drug manufacturers, drug distributors, and medical institutions shall formulate prices in accordance with the principles of fairness, reasonableness, good faith, and credit, and consistency between quality and price, so as to provide reasonably priced drugs for drug users.
　　The drug marketing authorization holders, drug manufacturers, drug distributors, and medical institutions shall abide by the provisions of the State Council's drug price management department on drug price management, formulate and indicate retail prices for drugs, and prohibit acts such as profiteering, price monopoly, and price fraud.
　　Article 86. Drug marketing authorization holders, drug manufacturers, drug distributors, and medical institutions shall provide the drug price management department with information on the actual purchase and sales prices and quantities of their drugs in accordance with the law.
　　Article 87. Medical institutions shall provide patients with a price list of the drugs used, truthfully publish the prices of their commonly used drugs in accordance with regulations, and strengthen the management of rational drug use. The specific methods shall be formulated by the State Council's health and health administrative department.
　　Article 88. It is prohibited for drug marketing authorization holders, drug manufacturers, drug distributors, and medical institutions to give or receive rebates or other improper benefits in the purchase and sale of drugs.
　　It is prohibited for drug marketing authorization holders, drug manufacturers, drug distributors, or agents to give property or other improper benefits to the heads, drug procurement personnel, physicians, pharmacists, and other relevant personnel of medical institutions that use their drugs under any name. It is prohibited for the heads, drug procurement personnel, physicians, pharmacists, and other relevant personnel of medical institutions to receive property or other improper benefits given by drug marketing authorization holders, drug manufacturers, drug distributors, or agents under any name.
　　Article 89. Drug advertisements shall be approved by the advertisement review agency determined by the people's government of the province, autonomous region, or municipality directly under the Central Government where the advertiser is located; they shall not be released without approval.
　　Article 90. The content of drug advertisements shall be true and lawful, and shall be based on the drug instructions approved by the State Council's drug supervision and administration department, and shall not contain false content.
　　Drug advertisements shall not contain assertions or guarantees of efficacy and safety; they shall not use the names or images of state organs, scientific research units, academic institutions, industry associations, or experts, scholars, physicians, pharmacists, patients, etc. for recommendation or certification.
　　Non-drug advertisements shall not contain any publicity related to drugs.
　　Article 91. For drug prices and advertisements, if not provided for in this Law, 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, the Advertisement Law of the People's Republic of China, etc. shall apply.

Chapter 9 Drug Reserve and Supply

　　Article 92. The state shall implement a drug reserve system and establish a two-level drug reserve system at the central and local levels.
　　In the event of major disasters, epidemics, or other emergencies, drugs may be urgently mobilized in accordance with the provisions of the Emergency Response Law of the People's Republic of China.
　　Article 93. The state shall implement a basic drug system, select an appropriate number of basic drug varieties, strengthen the organization of production and reserves, improve the supply capacity of basic drugs, and meet the basic drug needs for disease prevention and control.
　　Article 94. The state shall establish a drug supply and demand monitoring system, timely collect and summarize and analyze the supply and demand information of short-supply drugs, issue early warnings for short-supply drugs, and take countermeasures.
　　Article 95. The state shall implement a short-supply drug list management system. The specific methods shall be formulated by the State Council's health and health administrative department in conjunction with the State Council's drug supervision and administration department and other departments.
　　If a drug marketing authorization holder stops producing short-supply drugs, it shall report to 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 directly under the Central Government in accordance with regulations.
　　Article 96. The state encourages the research and development and production of short-supply drugs, and gives priority to the review and approval of clinically urgently needed short-supply drugs and new drugs for the prevention and control of major infectious diseases and rare diseases.
　　Article 97. For short-supply 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 the production and supply of drugs in accordance with regulations.

Chapter 10 Supervision and Management

　　Article 98. It is prohibited to produce (including preparation, hereinafter the same), sell, or use fake or substandard drugs.
　　The following situations constitute fake drugs:
　　(1) The components of the drug do not conform to the components stipulated in the national drug standards;
　　(2) Non-drugs are passed off as drugs or one type of drug is passed off as another;
　　(3) Deteriorated drugs;
　　(4) The indicated uses or functional indications of the drug exceed the prescribed scope.
　　The following situations constitute substandard drugs:
　　(1) The content of the drug components does not meet the national drug standards;
　　(2) Contaminated drugs;
　　(3) Drugs without indicated or altered expiration dates;
　　(4) Drugs without indicated or altered product batch numbers;
　　(5) Expired drugs;
　　(6) Drugs with preservatives or excipients added without authorization;
　　(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 in accordance with regulations to produce drugs.
　　Article 99. The drug supervision and administration department shall supervise and inspect the research, production, operation, and use of drugs by drug-using units in accordance with the provisions of laws and regulations. When necessary, it may conduct extended inspections of units and individuals that provide products or services for the research, production, operation, and use of drugs. Relevant units and individuals shall cooperate and shall not refuse or conceal.
　　The drug supervision and administration department shall implement key supervision and inspection of high-risk drugs.
　　For those with evidence that may pose safety hazards, the drug supervision and administration department shall, based on the results of supervision and inspection, take measures such as warning, interviews, time-limited rectification, and suspension of production, sales, use, and import, and promptly publish the results of the inspection and handling.
　　When conducting supervision and inspection, the drug supervision and administration department shall present proof documents, and shall keep confidential any trade secrets learned during supervision and inspection.
　　第一百条　药品监督管理部门根据监督管理的需要，可以对药品质量进行抽查检验。抽查检验应当按照规定抽样，并不得收取任何费用；抽样应当购买样品。所需费用按照国务院规定列支。
　　对有证据证明可能危害人体健康的药品及其有关材料，药品监督管理部门可以查封、扣押，并在七日内作出行政处理决定；药品需要检验的，应当自检验报告书发出之日起十五日内作出行政处理决定。
　　第一百零一条　国务院和省、自治区、直辖市人民政府的药品监督管理部门应当定期公告药品质量抽查检验结果；公告不当的，应当在原公告范围内予以更正。
　　第一百零二条　当事人对药品检验结果有异议的，可以自收到药品检验结果之日起七日内向原药品检验机构或者上一级药品监督管理部门设置或者指定的药品检验机构申请复验，也可以直接向国务院药品监督管理部门设置或者指定的药品检验机构申请复验。受理复验的药品检验机构应当在国务院药品监督管理部门规定的时间内作出复验结论。
　　第一百零三条　药品监督管理部门应当对药品上市许可持有人、药品生产企业、药品经营企业和药物非临床安全性评价研究机构、药物临床试验机构等遵守药品生产质量管理规范、药品经营质量管理规范、药物非临床研究质量管理规范、药物临床试验质量管理规范等情况进行检查，监督其持续符合法定要求。
　　第一百零四条　国家建立职业化、专业化药品检查员队伍。检查员应当熟悉药品法律法规，具备药品专业知识。
　　第一百零五条　药品监督管理部门建立药品上市许可持有人、药品生产企业、药品经营企业、药物非临床安全性评价研究机构、药物临床试验机构和医疗机构药品安全信用档案，记录许可颁发、日常监督检查结果、违法行为查处等情况，依法向社会公布并及时更新；对有不良信用记录的，增加监督检查频次，并可以按照国家规定实施联合惩戒。
　　第一百零六条　药品监督管理部门应当公布本部门的电子邮件地址、电话，接受咨询、投诉、举报，并依法及时答复、核实、处理。对查证属实的举报，按照有关规定给予举报人奖励。
　　药品监督管理部门应当对举报人的信息予以保密，保护举报人的合法权益。举报人举报所在单位的，该单位不得以解除、变更劳动合同或者其他方式对举报人进行打击报复。
　　第一百零七条　国家实行药品安全信息统一公布制度。国家药品安全总体情况、药品安全风险警示信息、重大药品安全事件及其调查处理信息和国务院确定需要统一公布的其他信息由国务院药品监督管理部门统一公布。药品安全风险警示信息和重大药品安全事件及其调查处理信息的影响限于特定区域的，也可以由有关省、自治区、直辖市人民政府药品监督管理部门公布。未经授权不得发布上述信息。
　　公布药品安全信息，应当及时、准确、全面，并进行必要的说明，避免误导。
　　任何单位和个人不得编造、散布虚假药品安全信息。
　　第一百零八条　县级以上人民政府应当制定药品安全事件应急预案。药品上市许可持有人、药品生产企业、药品经营企业和医疗机构等应当制定本单位的药品安全事件处置方案，并组织开展培训和应急演练。
　　发生药品安全事件，县级以上人民政府应当按照应急预案立即组织开展应对工作；有关单位应当立即采取有效措施进行处置，防止危害扩大。
　　第一百零九条　药品监督管理部门未及时发现药品安全系统性风险，未及时消除监督管理区域内药品安全隐患的，本级人民政府或者上级人民政府药品监督管理部门应当对其主要负责人进行约谈。
　　地方人民政府未履行药品安全职责，未及时消除区域性重大药品安全隐患的，上级人民政府或者上级人民政府药品监督管理部门应当对其主要负责人进行约谈。
　　被约谈的部门和地方人民政府应当立即采取措施，对药品监督管理工作进行整改。
约谈情况和整改情况应当纳入有关部门和地方人民政府药品监督管理工作评议、考核记录。
　　第一百一十条　地方人民政府及其药品监督管理部门不得以要求实施药品检验、审批等手段限制或者排斥非本地区药品上市许可持有人、药品生产企业生产的药品进入本地区。
　　第一百一十一条　药品监督管理部门及其设置或者指定的药品专业技术机构不得参与药品生产经营活动，不得以其名义推荐或者监制、监销药品。
　　药品监督管理部门及其设置或者指定的药品专业技术机构的工作人员不得参与药品生产经营活动。
　　第一百一十二条　国务院对麻醉药品、精神药品、医疗用毒性药品、放射性药品、药品类易制毒化学品等有其他特殊管理规定的，依照其规定。
　　第一百一十三条　药品监督管理部门发现药品违法行为涉嫌犯罪的，应当及时将案件移送公安机关。
　　对依法不需要追究刑事责任或者免予刑事处罚，但应当追究行政责任的，公安机关、人民检察院、人民法院应当及时将案件移送药品监督管理部门。
　　公安机关、人民检察院、人民法院商请药品监督管理部门、生态环境主管部门等部门提供检验结论、认定意见以及对涉案药品进行无害化处理等协助的，有关部门应当及时提供，予以协助。

Chapter 11 Legal Liabilities

　　第一百一十四条　违反本法规定，构成犯罪的，依法追究刑事责任。
　　第一百一十五条　未取得药品生产许可证、药品经营许可证或者医疗机构制剂许可证生产、销售药品的，责令关闭，没收违法生产、销售的药品和违法所得，并处违法生产、销售的药品（包括已售出和未售出的药品，下同）货值金额十五倍以上三十倍以下的罚款；货值金额不足十万元的，按十万元计算。
　　Article 116. The production and sale of fake drugs shall be subject to confiscation of the illegally produced and sold drugs and illegal gains, order to suspend production and business for rectification, revocation of drug approval documents, and a fine of fifteen to 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, the drug production license, drug business license, or medical institution preparation license shall be revoked, and no corresponding application shall be accepted within ten years; for foreign companies that are drug marketing authorization holders, their drug imports shall be prohibited for ten years.
　　Article 117. The production and sale of substandard drugs shall be subject to confiscation of the illegally produced and sold drugs and illegal gains, and a fine of ten to twenty times the value of the illegally produced and sold drugs; if the value of illegally produced and 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, an order to suspend production and business for rectification shall be issued until the revocation of drug approval documents, drug production license, drug business license, or medical institution preparation license.
　　For the production and sale of Chinese medicine pieces that do not meet drug standards but do not affect safety and effectiveness, a time-limited order for correction shall be issued with a warning; a fine of more than 100,000 yuan but less than 500,000 yuan may be imposed.
　　Article 118. For the production and sale of fake drugs, or the production and sale of substandard drugs with serious circumstances, the legal representative, main person in charge, directly responsible person in charge, and other responsible personnel shall be subject to confiscation of income obtained from the unit during the period of the illegal act, and a fine of 30% to three times the income, a lifetime ban from engaging in drug production and business activities, and may be detained by the public security organ for five to fifteen days.
　　The raw materials, excipients, packaging materials, and production equipment specifically used by the producer to produce fake drugs and substandard drugs shall be confiscated.
　　Article 119. Drug-using units that use fake or substandard drugs shall be punished according to the provisions on the sale of fake drugs and retail of substandard drugs; in serious cases, for the legal representative, main person in charge, directly responsible person in charge, and other responsible personnel who have medical and health personnel practice certificates, their practice certificates shall also be revoked.
　　Article 120. Those who, knowing or should have known that they are fake drugs, substandard drugs, or drugs stipulated in Article 124, paragraph 1, items 1 to 5, provide storage, transportation, and other convenient conditions, shall have all storage and transportation income confiscated, and be fined one to five times the illegal income; in serious cases, they shall also be fined five to 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 for fake and substandard drugs shall, in accordance with the law, state the quality inspection conclusions of the drug testing institution.
　　Article 122. For the forging, alteration, leasing, lending, or illegal sale of licenses or drug approval documents, the illegal gains shall be confiscated, and a fine of one to five times the illegal gains shall be imposed; in serious cases, a fine of five to fifteen times the illegal gains shall be imposed, and the drug production license, drug business license, medical institution preparation license, or drug approval document shall be revoked; for the legal representative, main person in charge, directly responsible person in charge, and other responsible personnel, a fine of 20,000 to 200,000 yuan shall be imposed, and they shall be prohibited from engaging in drug production and business activities for ten years, and may be detained by the public security organ for five to fifteen days; if the illegal gains are less than 100,000 yuan, it shall be calculated as 100,000 yuan.
　　Article 123. For providing false certificates, data, materials, samples, or using other means to obtain clinical trial licenses, drug production licenses, drug business licenses, medical institution preparation licenses, or drug registration licenses, the relevant licenses shall be revoked, no corresponding application shall be accepted within ten years, and a fine of 500,000 yuan to 5 million yuan shall be imposed; in serious cases, for the legal representative, main person in charge, directly responsible person in charge, and other responsible personnel, a fine of 20,000 to 200,000 yuan shall be imposed, and they shall be prohibited from engaging in drug production and business activities for ten years, and may be detained by the public security organ for five to fifteen days.
　　Article 124. Violation of the provisions of this Law and committing any of the following acts shall result in confiscation of the 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, an order to suspend production and business for rectification, and a fine of fifteen to 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, the drug approval document shall be revoked up to the revocation of the drug production license, drug business license, or medical institution preparation license; for the legal representative, main person in charge, directly responsible person in charge, and other responsible personnel, the income obtained from the unit during the period of the illegal act shall be confiscated, and a fine of 30% to three times the income shall be imposed, and they shall be prohibited from engaging in drug production and business activities for ten years to a lifetime, and may be detained by the public security organ for five to fifteen days:
　　(1) Producing or importing drugs without obtaining drug approval documents;
　　(2) Producing or importing drugs using drug approval documents obtained through deceptive means;
　　(3) Producing drugs using raw materials that have not been reviewed and approved;
　　(4) Selling drugs without inspection when inspection is required;
　　(5) Producing and selling drugs that are prohibited by the State Council's drug supervision and administration department;
　　(6) Fabricating production and inspection records;
　　(7) Making major changes during drug production without approval.
　　The sale of drugs stipulated in items (1) to (3) of the preceding paragraph, or the use of drugs stipulated in items (1) to (5) of the preceding paragraph by drug-using units, shall be punished in accordance with the provisions of the preceding paragraph; in serious cases, for the legal representative, main person in charge, directly responsible person in charge, and other responsible personnel of drug-using units who have medical and health personnel practice certificates, their practice certificates shall also be revoked.
　　For the unauthorized import of a small amount of legally marketed drugs from abroad, if the circumstances are minor, the penalty may be mitigated or exempted according to the law.
　　Article 125. Violation of the provisions of this Law and committing any of the following acts shall result in confiscation of the illegally produced and sold drugs and illegal gains, as well as packaging materials and containers, an order to suspend production and business for rectification, and a fine of 500,000 yuan to 5 million yuan; in serious cases, the drug approval document, drug production license, and drug business license shall be revoked, and a fine of 20,000 yuan to 200,000 yuan shall be imposed on the legal representative, main person in charge, directly responsible person in charge, and other responsible personnel, and they shall be prohibited from engaging in drug production and business activities for ten years to a lifetime:
　　(1) Conducting drug clinical trials without approval;
　　(2) Producing drugs using packaging materials or containers that are in direct contact with drugs and have not been reviewed, or selling such drugs;
　　(3) Using unapproved labels or instructions.
　　Article 126 Except as otherwise provided in this Law, if a drug marketing authorization holder, drug manufacturer, drug wholesaler, pharmaceutical non-clinical safety evaluation research institution, or drug clinical trial institution fails to comply with the Good Manufacturing Practice for Drugs, the Good Wholesale Practice for Drugs, the Good Quality Management Practice for Non-clinical Research of Drugs, or the Good Clinical Practice for Drugs, etc., it shall be ordered to rectify within a time limit and given a warning; if it fails to rectify within the time limit, it shall be fined not less than RMB 100,000 and not more than RMB 500,000; in case of serious circumstances, it shall be fined not less than RMB 500,000 and not more than RMB 2,000,000, and ordered to suspend production and operation for rectification until the drug approval documents, drug production license, drug business license, etc. are revoked. Pharmaceutical non-clinical safety evaluation research institutions and drug clinical trial institutions shall not conduct pharmaceutical non-clinical safety evaluation research or drug clinical trials for five years. The legal representative, the person in charge, the person directly in charge, and other responsible personnel shall have their income from the unit during the period of the illegal act confiscated, and be fined not less than 10% and not more than 50% of the income. They shall be banned from engaging in drug production and business activities for ten years or for life.
　　Article 127 If any of the following acts are committed in violation of this Law, the violator shall be ordered to rectify within a time limit and given a warning; if it fails to rectify within the time limit, it shall be fined not less than RMB 100,000 and not more than RMB 500,000:
　　(1) Conducting bioequivalence tests without filing;
　　(2) During drug clinical trials, if safety problems or other risks are found, the clinical trial applicant fails to adjust the clinical trial plan in time, suspend or terminate the clinical trial, or fails to report to the State Drug Administration;
　　(3) Failing to establish and implement a drug traceability system in accordance with regulations;
　　(4) Failing to submit an annual report as required;
　　(5) Failing to file or report changes in the drug production process in accordance with regulations;
　　(6) Failing to formulate a post-marketing risk management plan for drugs;
　　(7) Failing to conduct post-marketing research or evaluation of drugs as required.
　　Article 128 Except for cases where penalties should be imposed on counterfeit drugs and substandard drugs in accordance with the law, if the drug packaging does not have labels or instructions printed or affixed in accordance with regulations, or if the labels or instructions do not indicate relevant information or bear the prescribed marks in accordance with regulations, the violator shall be ordered to correct the violation and given a warning; in serious cases, the drug registration certificate shall be revoked.
　　Article 129 If, in violation of this Law, a drug marketing authorization holder, a drug manufacturer, a drug wholesaler, or a medical institution fails to purchase drugs from a drug marketing authorization holder or an enterprise with drug production or operation qualifications, it shall be ordered to rectify the violation, and the illegally purchased drugs and illegal gains shall be confiscated, and a fine of not less than two times and not more than ten times the value of the illegally purchased drugs shall be imposed; in serious cases, a fine of not less than ten times and not more than thirty times the value of the goods shall be imposed, and the drug approval documents, drug production license, drug business license, or medical institution practice license shall be revoked; if the value of the goods is less than RMB 50,000, it shall be calculated as RMB 50,000.
　　Article 130 If a drug wholesaler violates this Law by failing to keep records of drug purchases and sales as required, failing to correctly explain the usage, dosage, etc., of retail drugs, or failing to dispense prescriptions as required, it shall be ordered to correct the violation and given a warning; in serious cases, the drug business license shall be revoked.
　　Article 131 If a third-party provider of drug online trading platforms violates this Law by failing to perform its obligations of qualification review, reporting, and ceasing to provide online trading platform services, it shall be ordered to correct the violation, its illegal gains shall be confiscated, and it shall be fined not less than RMB 200,000 and not more than RMB 2,000,000; in serious cases, it shall be ordered to suspend operations for rectification, and a fine of not less than RMB 2,000,000 and not more than RMB 5,000,000 shall be imposed.
　　Article 132 If imported drugs that have obtained drug registration certificates are not registered with the drug regulatory department at the port of entry as required, the violator shall be ordered to rectify the violation within a time limit and given a warning; if it fails to rectify within the time limit, the drug registration certificate shall be revoked.
　　Article 133 If a medical institution violates this Law by selling its own preparations on the market, it shall be ordered to correct the violation, the illegally sold preparations and illegal gains shall be confiscated, and a fine of not less than two times and not more than five times the value of the illegally sold preparations shall be imposed; in serious cases, a fine of not less than five times and not more than fifteen times the value of the goods shall be imposed; if the value of the goods is less than RMB 50,000, it shall be calculated as RMB 50,000.
　　Article 134 If a drug marketing authorization holder fails to conduct drug adverse reaction monitoring or report suspected adverse drug reactions as required, it shall be ordered to correct the violation within a time limit and given a warning; if it fails to rectify within the time limit, it shall be ordered to suspend production and operation for rectification, and be fined not less than RMB 100,000 and not more than RMB 1,000,000.
　　If a drug wholesaler fails to report suspected adverse drug reactions as required, it shall be ordered to correct the violation within a time limit and given a warning; if it fails to rectify within the time limit, it shall be ordered to suspend production and operation for rectification, and be fined not less than RMB 50,000 and not more than RMB 500,000.
　　If a medical institution fails to report suspected adverse drug reactions as required, it shall be ordered to correct the violation within a time limit and given a warning; if it fails to rectify within the time limit, it shall be fined not less than RMB 50,000 and not more than RMB 500,000.
　　Article 135 If a drug marketing authorization holder refuses to recall drugs after being ordered to recall them by the drug regulatory department of the people's government of a province, autonomous region, or municipality directly under the Central Government, it shall be fined not less than five times and not more than ten times the value of the drugs to be recalled; if the value of the drugs is less than RMB 100,000, it shall be calculated as RMB 100,000; in serious cases, the drug approval documents, drug production license, and drug business license shall be revoked, and the legal representative, person in charge, person directly in charge, and other responsible personnel shall be fined not less than RMB 20,000 and not more than RMB 200,000. Drug manufacturers, drug wholesalers, and medical institutions that refuse to cooperate with the recall shall be fined not less than RMB 100,000 and not more than RMB 500,000.
　　Article 136 If the drug marketing authorization holder is a foreign enterprise, and the enterprise legal person designated by it in China fails to fulfill its relevant obligations in accordance with this Law, the provisions of this Law concerning the legal liabilities of the drug marketing authorization holder shall apply.
　　Article 137 The following acts shall be subject to heavier penalties within the range of penalties prescribed in this Law:
　　(1) Using narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, or drug-related easily controlled chemicals to impersonate other drugs, or using other drugs to impersonate the above-mentioned drugs;
　　(2) Manufacturing or selling counterfeit or substandard drugs mainly used by pregnant women, children;
　　(3) Manufacturing or selling biological products that are counterfeit or substandard drugs;
　　(4) Manufacturing or selling counterfeit or substandard drugs, resulting in personal injury;
　　(5) Manufacturing or selling counterfeit or substandard drugs, and re-offending after being dealt with.
　　(6) Refusal of or evasion from supervision and inspection; forging, destroying, or concealing relevant evidence; or unauthorized use of sealed or seized items.
　　Article 138 A pharmaceutical inspection institution that issues a false inspection report shall be ordered to correct the error, given a warning, and fined not less than 200,000 yuan and not more than 1 million yuan. The person directly in charge and other directly responsible personnel shall be given demotion, dismissal, or expulsion according to law, their illegal gains shall be confiscated, and they shall be fined not more than 50,000 yuan. In serious cases, their inspection qualifications shall be revoked. If the inspection results issued by a pharmaceutical inspection institution are untrue and cause losses, it shall bear the corresponding compensation liability.
　　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 respective responsibilities; the revocation or cancellation of licenses shall be decided by the original approving and licensing departments.
　　Article 140 If a drug marketing authorization holder, drug production enterprise, drug business enterprise, or medical institution violates the provisions of this Law in employing personnel, the drug supervision and administration department or the health and health administrative department shall order the dismissal of the personnel and impose a fine of not less than 50,000 yuan and not more than 200,000 yuan.
　　Article 141 If a drug marketing authorization holder, drug production enterprise, drug business enterprise, or medical institution gives or receives rebates or other improper benefits in the purchase and sale of drugs, or if a drug marketing authorization holder, drug production enterprise, drug business enterprise, or agent gives property or other improper benefits to the person in charge, drug procurement personnel, physicians, pharmacists, and other relevant personnel of a medical institution that uses its drugs, the market supervision and administration department shall confiscate the illegal gains and impose a fine of not less than 300,000 yuan and not more than 3 million yuan; in serious cases, the business license of the drug marketing authorization holder, drug production enterprise, or drug business enterprise shall be revoked, and the drug approval documents, drug production licenses, and drug business licenses shall be revoked by the drug supervision and administration department.
　　If a drug marketing authorization holder, drug production enterprise, or drug business enterprise offers bribes to state functionaries in the research, production, or operation of drugs, the legal representative, principal person in charge, person directly in charge, and other responsible personnel shall be permanently prohibited from engaging in drug production and operation activities.
　　Article 142 If the person in charge, procurement personnel, and other relevant personnel of a drug marketing authorization holder, drug production enterprise, or drug business enterprise receive property or other improper benefits from other drug marketing authorization holders, drug production enterprises, drug business enterprises, or agents in the purchase and sale of drugs, the illegal gains shall be confiscated, and they shall be punished according to law; in serious cases, they shall be prohibited from engaging in drug production and operation activities for five years.
　　If the person in charge, drug procurement personnel, physicians, pharmacists, and other relevant personnel of a medical institution receive property or other improper benefits from a drug marketing authorization holder, drug production enterprise, drug business enterprise, or agent, the health and health administrative department or the unit shall give them a disciplinary sanction, and the illegal gains shall be confiscated; in serious cases, their practice certificates shall also be revoked.
　　Article 143 If, in violation of the provisions of this Law, false information on drug safety is fabricated and disseminated, and constitutes a violation of public security management, the public security organs shall impose public security management penalties according to law.
　　Article 144 If a drug marketing authorization holder, drug production enterprise, drug business enterprise, or medical institution violates the provisions of this Law and causes harm to drug users, it shall bear compensation liability according to law.
　　If harm is suffered due to drug quality problems, the victim may request compensation for losses from the drug marketing authorization holder or drug production enterprise, or from the drug business enterprise or medical institution. Upon receiving a compensation request from the victim, the first responsible party shall implement the first-responsible system and make advance payment; after advance payment, it may seek recourse according to law.
　　If counterfeit drugs or substandard drugs are produced, or if counterfeit drugs or substandard drugs are known to be such and are still sold or used, the victim or his or her close relatives may, in addition to requesting compensation for losses, also request payment of compensation ten times the price or three times the loss; if the additional compensation amount is less than 1,000 yuan, it shall be 1,000 yuan.
　　Article 145 If a drug supervision and administration department or its established or designated drug professional and technical institution participates in drug production and operation activities, its superior competent authority shall order it to correct the error and confiscate its illegal income; in serious cases, the person directly in charge and other directly responsible personnel shall be given disciplinary sanctions according to law.
　　If a staff member of a drug supervision and administration department or its established or designated drug professional and technical institution participates in drug production and operation activities, he or she shall be given disciplinary sanctions according to law.
　　Article 146 If a drug supervision and administration department or its established or designated pharmaceutical inspection institution illegally collects inspection fees in drug supervision and inspection, the relevant government department shall order the return of the fees, and the person directly in charge and other directly responsible personnel shall be given disciplinary sanctions according to law; in serious cases, their inspection qualifications shall be revoked.
　　Article 147 If a drug supervision and administration department violates the provisions of this Law and commits any of the following acts, the relevant licenses shall be revoked, and the person directly in charge and other directly responsible personnel shall be given disciplinary sanctions according to law:
　　(1) Approving the conduct of 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 business licenses, or medical institution preparation licenses to units that do not meet the conditions.
　　Article 148 If a local people's government at or above the county level violates the provisions of this Law and commits any of the following acts, the person directly in charge and other directly responsible personnel shall be given a demerit or a major demerit; in serious cases, they shall be given demotion, dismissal, or expulsion:
　　(1) Concealing, falsifying, delaying, or omitting reports of drug safety incidents;
　　(2) Failing to eliminate major regional drug safety hazards in a timely manner, resulting in the occurrence of particularly serious drug safety incidents or consecutive serious drug safety incidents within its administrative region;
　　(3) Failing to perform its duties effectively, resulting in serious adverse effects or major losses.
　　Article 149 If a drug supervision and administration department or other relevant department violates the provisions of this Law and commits any of the following acts, the person directly in charge and other directly responsible personnel shall be given a demerit or a major demerit; in relatively serious cases, they shall be given demotion or dismissal; in serious cases, they shall be given expulsion:
　　(1) Concealing, falsifying, delaying, or omitting reports of drug safety incidents;
　　(2) Failing to investigate and deal with discovered illegal acts of drug safety in a timely manner;
　　(3) Failing to discover systemic risks of drug safety in a timely manner, or failing to eliminate drug safety hazards within the supervision and administration area in a timely manner, resulting in serious effects;
　　(4) Other failures to perform drug supervision and administration responsibilities, resulting in serious adverse effects or major losses.
　　Article 150 If a drug supervision and administration personnel abuses his or her power, practices favoritism or malfeasance, or neglects his or her duties, he or she shall be given disciplinary sanctions according to law.
If there is dereliction of duty or neglect of duty in dealing with illegal acts of counterfeit drugs or substandard drugs, the person directly in charge and other directly responsible personnel of the drug supervision and administration department shall be given heavier disciplinary sanctions according to law.
　　Article 151. The value of goods stipulated in this Chapter shall be calculated based on the marked price of the illegally produced and 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 implemented in accordance with the provisions of relevant laws and regulations.
　　Article 153. The management measures for regional folk medicinal materials commonly used shall be formulated by the State Drug Administration in conjunction with the State Administration of Traditional Chinese Medicine.
　　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.