Pharmaceutical Administration Law of the People's Republic of China (2019 Revision)

Pharmaceutical Administration Law of the People's Republic of China (2019 Revision) Order of the President of the People's Republic of China (No. 31) The Pharmaceutical Administration Law of the People's Republic of China as revised at the Twelfth Session of the Standing Committee of the Thirteenth National People's Congress of the People's Republic of China on August 26, 2019, is hereby issued and shall come into force on December 1, 2019. President of the People's Republic of China: Xi Jinping August 26, 2019 Pharmaceutical Administration Law of the People's Republic of China (Adopted at the Seventh Session of the Standing Committee of the Sixth National People's Congress on September 20, 1984, revised at the Twentieth Session of the Ninth National People's Congress on February 28, 2001 and amended for the first time in accordance with the Decision on Amending Seven Laws Including the Marine Environment Protection Law of the People's Republic of China at the Sixth Session of the Standing Committee of the Twentieth National People's Congress on December 28, 2013; amended for the second time in accordance with the Decision on Amending the Pharmaceutical Administration Law of the People's Republic of China at the 14th Session of the Standing Committee of the Twelfth National People's Congress of the People's Republic of China on April 24, 2015; and revised for the second time at the Twelfth Session of the Standing Committee of the Thirteenth National People's Congress on August 26, 2019) Contents Chapter I General Provisions Chapter II Pharmaceutical Development and Registration Chapter III Pharmaceutical Marketing Authorization Holders Chapter IV Pharmaceutical Production Chapter V Pharmaceutical Distribution Chapter VI Medical Institutions' Management of Pharmaceutical Affairs Chapter VII Post-market Pharmaceutical Management Chapter VIII Pharmaceutical Prices and Advertising Chapter IX Pharmaceutical Reserves and Supply Chapter X Supervision and Administration Chapter XI Legal Liability Chapter XII Supplementary Provisions Chapter I General Provisions Article 1 This Law is enacted for the purposes of strengthening pharmaceutical administration, ensuring pharmaceutical quality, guaranteeing the medication safety and lawful rights and interests of the public, and protecting and promoting public health. Article 2 The law shall be applicable to the development, production, distribution, use, and supervision and administration of pharmaceuticals within the territory of the People's Republic of China. For the purpose of this Law, “pharmaceuticals” means the articles intended for use in the prevention, treatment or diagnosis of human diseases, or intended to effect the purposive regulation of human physiological functions, for which indications or major functions, usage and dosage are prescribed, including Chinese medicine, chemical pharmaceuticals, and biological products. Article 3 Pharmaceutical administration shall center on people's health, adhere to the principles of risk management, management and control in the whole process, and co-governance by whole society, establish a scientific and strict supervision and administration system, comprehensively improve pharmaceutical quality, and guarantee the safety, effectiveness, and accessibility of pharmaceuticals. Article 4 The state shall develop both modern and traditional pharmaceuticals and give full play to their role in the prevention and treatment of diseases and in health care. The state shall protect the resources of wild medicinal materials and varieties of Chinese medicine and encourage the cultivation of genuine Chinese medicinal materials. Article 5 The state shall encourage the research and production of new medicine and protect the legal rights and interests of its citizens, natural persons and other organizations in the research and development of new medicine. Article 6 The state shall implement a pharmaceutical marketing authorization holder system for pharmaceutical management. A pharmaceutical marketing authorization holder shall be responsible for the safety, effectiveness, and quality controllability of pharmaceuticals during the whole process of the development, production, distribution, and use of the pharmaceuticals, as legally required. Article 7 One that engages in pharmaceutical development, manufacturing, distribution or use activities shall abide by the laws, regulations, rules, standards, and specifications and ensure the authenticity, accuracy, integrity, and traceability of information in the whole process. Article 8 The medical products administration under the State Council shall be responsible for the supervision and administration of pharmaceuticals throughout the country. Other relevant departments under the State Council shall be responsible for pharmaceuticals-related supervision and administration within the scope of their functions. The medical products administration under the State Council shall cooperate with other relevant departments under the State Council in implementing national pharmaceutical industry development plans and industry policies. The medical products administrations of the people's governments of provinces, autonomous regions, and municipalities directly under the central government shall be responsible for the supervision and administration of pharmaceuticals within their administrative regions. The department of a people's government at or above districted city or county level charged with the function of pharmaceutical supervision and administration (hereinafter referred to as the “medical products administration”) shall be responsible for the supervision and administration of pharmaceuticals within its administrative region. The relevant departments of local people's governments at or above county level shall be responsible for pharmaceuticals-related supervision and administration within the scope of their functions. Article 9 A local people's government at or above county level shall be responsible the supervision and administration of pharmaceuticals within its administrative region, lead, organize, and coordinate the supervision and administration of pharmaceuticals and pharmaceutical safety emergency response work within the administrative region in a unified manner, and establish and improve a supervision and administration mechanism and an information sharing mechanism for pharmaceutical safety. Article 10 A local people's government at or above county level shall incorporate pharmaceutical safety work into the national economic and social development plan at the same level, include the funds for the pharmaceutical safety work in its budget, strengthen the capacity building for the supervision and administration of pharmaceuticals, and provide guarantees for pharmaceutical safety. Article 11 A specialized pharmaceuticals technical institution established or designated by any medical products administration shall undertake evaluation, inspection, verification, monitoring and evaluation, and other work necessary for the implementation of the supervision and administration of pharmaceuticals according to the law. Article 12 The state shall establish and improve a pharmaceutical traceability system. The medical products administration under the State Council shall develop unified pharmaceutical traceability standards and specifications, advance the mutual accessibility and sharing of pharmaceutical traceability information, and achieving pharmaceutical traceability. The state shall establish a pharmacovigilance system to monitor, identify, assess, and control adverse pharmaceutical reactions and other harmful reactions associated with the use of pharmaceuticals. Article 13 People's governments at all levels and their relevant departments, pharmaceutical industry associations, and the like shall strengthen publicity and education about pharmaceutical safety and disseminate pharmaceutical safety laws and regulations and other knowledge. The news media shall give public-welfare publicity on pharmaceutical safety laws and regulations and other knowledge and conduct public opinion supervision of illegal pharmaceutical activities. A report on pharmaceuticals shall be comprehensive, scientific, objective, and fair. Article 14 A pharmaceutical industry association shall strengthen industry self-regulation, establish and improve industry standards of practice, promote the building of the industry honesty system, and guide and supervise its members conducting pharmaceutical production and distribution activities according to the law. Article 15 People's governments at or above county level and their relevant departments shall commend and reward entities and individuals that have made outstanding contributions to the development, production, distribution, use, and supervision and administration of pharmaceuticals in accordance with the relevant provisions issued by the state. Chapter II Pharmaceutical Development and Registration Article 16 The state shall support pharmaceutical innovations oriented to clinical value which have clear or special curative effect on human diseases, encourage the development of new pharmaceuticals which are of a new mechanism of action, treat serious life-threatening diseases or rare diseases, or regulate and intervene in human body in a multi-target and systematic manner, and promote the advancement of pharmaceutical technology. The state shall encourage research on science and technology for Chinese medicine and the development of Chinese medicine by using modern science and technology and traditional methods for researching Chinese medicine, establish and improve a technical assessment system that conforms to the characteristics of Chinese medicine, and promote the inheritance of and innovation in Chinese medicine. The state shall adopt effective measures to encourage the development of and innovation in pharmaceuticals for children's use, support the development of new varieties, dosage forms, and specifications of pharmaceuticals for children's use that meet the physiological characteristics of children, and prioritize the evaluation and approval of pharmaceuticals for children's use. Article 17 Engaging in pharmaceutical development activities shall be in conformity with the Good Laboratory Practice for Pharmaceuticals and the Good Clinical Practice for Pharmaceuticals, so as to ensure that pharmaceutical development continues to conform to statutory requirements in the whole process. The Good Laboratory Practice for Pharmaceuticals and the Good Clinical Practice for Pharmaceuticals shall be developed by the medical products administration under the State Council in conjunction with the relevant departments under the State Council. Article 18 Nonclinical laboratory studies on pharmaceuticals shall be conducted in conformity with the relevant provisions issued by the state, with personnel, site, equipment, instruments, and management systems appropriate for the research project, the authenticity of relevant data, information, and samples being ensured. Article 19 For clinical trials on pharmaceuticals, relevant data, information, and samples such as development methods, quality indicators, and pharmacological and toxicological testing results shall be truthfully submitted to in accordance with the rules of the medical products administration under the State Council and be subject to its approval. The medical products administration under the State Council shall, within 60 working days from the date of accepting the application for clinical trial, decide whether to grant approval and notify the sponsor of the clinical trial, and its failure to so notify shall be deemed as approval. Bioequivalence testing, if any, shall be filed with the medical products administration under the State Council. Clinical trials on pharmaceuticals shall be conducted in a clinical trial institution with appropriate conditions. A pharmaceutical clinical trial institution shall be under filing administration, for which specific measures shall be developed jointly by the medical products administration under the State Council and the health department under the State Council. Article 20 A clinical trial on pharmaceuticals shall be conducted in conformity with ethical principles, with a clinical trial protocol being developed, and reviewed and approved by the ethics committee. The ethics committee shall establish a working system for ethical review, ensure that the process of the ethical review is independent, objective, and fair, supervise the clinical trial on pharmaceuticals being conducted in a well-regulated manner, protect the lawful rights and interests of subjects, and safeguard the public interest. Article 21 For a clinical trial on pharmaceuticals, the objective, risk, and other particulars of the clinical trial shall be truthfully made known and explained to any of its subjects, or his or her guardian, an informed consent document voluntarily signed by the subject, or his or her guardian, shall be obtained, and effective measures shall be taken to protect the lawful rights and interests of the subject. Article 22 Where a safety problem or any other risk is discovered in the process of a clinical trial on pharmaceuticals, the sponsor of the clinical trial shall promptly adjust the clinical trial protocol, suspend or terminate the clinical trial, and report to the medical products administration under the State Council. When necessary, the medical products administration under the State Council may order adjustment of the clinical trial protocol, or suspension or termination of the clinical trial. Article 23 Pharmaceuticals undergoing clinical trials, intended for the treatment of a seriously life-threatening disease of which there has been no effective treatment, which possibly deliver benefits as indicated by medical observation, in a manner in conformity with the ethical principles, may, with approval and informed consent, be administered in the institution conducting the clinical trials to patients suffering from the same disease. Article 24 Pharmaceuticals marketed in China shall be approved by the medical products administration under the State Council and be with a pharmaceutical registration certificate, except Chinese medicinal materials and Chinese medicinal herb slices not under approval administration. The list of Chinese medicinal materials and Chinese medicinal herb slices subject to approval administration shall be developed by the medical products administration under the State Council in conjunction with the Chinese medicine department under the State Council. For the application for pharmaceutical registration, authentic, sufficient, and reliable data, information, and samples shall be provided, evidencing the safety, effectiveness, and quality controllability of the pharmaceuticals. Article 25 For pharmaceuticals under application for registration, the medical products administration under the State Council shall arrange for pharmaceutical, medical, and other technical personnel to conduct an evaluation to review the safety, effectiveness, and quality controllability of pharmaceuticals and the applicant's capabilities for quality management, risk prevention and control, and payment of damages, among others, and issue a pharmaceutical registration certificate, if the conditions are met. The medical products administration under the State Council shall, when approving pharmaceuticals, evaluate and approve chemical active ingredients, evaluate relevant inactive ingredients and packaging materials and containers in direct contact with pharmaceuticals, and confirm the quality standards, production processes, and labels and directions for use of the pharmaceuticals. For the purposes of this Law, “inactive ingredients” means excipients and additives used in the production of pharmaceuticals and the dispensing of prescriptions. Article 26 Pharmaceuticals intended for the treatment of a serious life-threatening disease of which there has been no effective treatment, or urgently needed for public health, of which clinical trials have generated data indicating the curative effects and are able to forecast the clinical value, may be approved subject to conditions, with relevant matters stated in the pharmaceutical registration certificate. Article 27 The medical products administration under the State Council shall improve the working system for the evaluation and approval of pharmaceuticals, strengthen capacity building, establish and improve communication and exchange, expert advice, and other mechanisms, optimize evaluation and approval processes, and improve the efficiency of evaluation and approval. The evaluation conclusions and basis approving the marketing of pharmaceuticals shall be disclosed to public in accordance with the law and accept social supervision. Any trade secret known in the course of evaluation and approval shall be kept confidential. Article 28 Pharmaceuticals shall meet national pharmaceutical standards. If the pharmaceutical quality standards confirmed by the medical products administration under the State Council are higher than the national pharmaceutical standards, the confirmed pharmaceutical quality standards shall prevail; and absent national pharmaceutical standards, the confirmed pharmaceutical quality standards shall be met. The Pharmacopoeia of the People's Republic of China and the pharmaceutical standards promulgated by the medical products administration under the State Council shall be national pharmaceutical standards. The medical products administration under the State Council shall, in conjunction with the health department under the State Council, organize a pharmacopoeia committee responsible for the development and revision of the national pharmaceutical standards. The pharmaceutical inspection institutions established or designated by the medical products administration under the State Council shall be responsible for the designation of State standard and contrastive pharmaceuticals. Article 29 The names of the pharmaceuticals listed in the national pharmaceutical standards are the generic names of the pharmaceuticals. Those names that have become the generic names of pharmaceuticals shall not be used as trademarks of pharmaceuticals. Chapter III Pharmaceutical Marketing Authorization Holders Article 30 “Pharmaceutical marketing authorization holder” means an enterprise, pharmaceutical development institution, or the like that has obtained a pharmaceutical registration certificate. A pharmaceutical marketing authorization holder shall be responsible for nonclinical laboratory studies, clinical trials, production and distribution, post-market studies, and the monitoring, reporting, and handling of adverse reactions in connection with pharmaceuticals in accordance with the provisions of this Law. Any other entity or individual engaged in the development, production, distribution, storage, transportation, and use of pharmaceuticals shall bear corresponding responsibilities according to the law. The legal representative or the principal person in charge of a pharmaceutical marketing authorization holder shall be fully responsible for pharmaceutical quality. Article 31 A pharmaceutical marketing authorization holder shall establish a pharmaceutical quality assurance system and appoint specialized personnel to be independently responsible for the management of pharmaceutical quality. A pharmaceutical marketing authorization holder shall regularly review the quality management system of the commissioned pharmaceutical producing enterprises and pharmaceutical distribution enterprises and supervise their continuing to process capabilities for quality assurance and control. Article 32 A pharmaceutical marketing authorization holder may produce pharmaceuticals by itself, or by a pharmaceutical producing enterprise commissioned to do so. A pharmaceutical marketing authorization holder shall obtain a pharmaceutical production license in accordance with the provisions of this Law, if it produces pharmaceuticals by itself, or commission a qualified pharmaceutical producing enterprise, if it commissions the production. The pharmaceutical marketing authorization holder and the commissioned producing enterprise shall enter into a commission agreement and a quality agreement and strictly fulfill the obligations stipulated in the agreements. The medical products administration under the State Council shall develop guidelines for commissioned pharmaceutical production and quality agreements to guide and supervise pharmaceutical marketing authorization holders and commissioned producing enterprises' fulfilling their obligation to assure pharmaceutical quality. The production of blood products, narcotic pharmaceuticals, psychotropic pharmaceuticals, medical toxic pharmaceuticals, and pharmaceutical precursor chemicals shall not be commissioned, unless otherwise required by the medical products administration under the State Council. Article 33 A pharmaceutical marketing authorization holder shall establish rules and procedures for pharmaceutical marketing clearances and review pharmaceuticals cleared with the pharmaceutical producing enterprise, so that clearance may be granted only after the qualified person has signed. Unless the national pharmaceutical standards are met, no clearance shall be granted. Article 34 A pharmaceutical marketing authorization holder may sell the pharmaceuticals for which a pharmaceutical registration certificate has been obtained by itself, or by a pharmaceutical distribution enterprise commissioned to do so. If a pharmaceutical marketing authorization holder is engaged in pharmaceutical retailing activities, it shall obtain a pharmaceutical distribution license. A pharmaceutical marketing authorization holder shall meet the conditions as set forth in Article 52 of this Law, if it sells pharmaceuticals by itself, or commission a qualified pharmaceutical distribution enterprise, if it commissions the sale. The pharmaceutical marketing authorization holder and the commissioned distribution enterprise shall conclude a commission agreement and strictly perform the obligations stipulated in the agreement. Article 35 Where a pharmaceutical marketing authorization holder, pharmaceutical producing enterprise, or pharmaceutical distribution enterprise commissions the storage or transportation of pharmaceuticals, it shall assess the quality assurance capability and risk management capability of the commissioned party, conclude a commission agreement with the commissioned party, stipulating responsibility for pharmaceutical quality, operating rules and procedures, and the like, and supervise the commissioned party. Article 36 Pharmaceutical marketing authorization holders, pharmaceutical producing enterprises, pharmaceutical distribution enterprises, and medical institutions shall establish and implement a pharmaceutical traceability system, provide traceability information as required, and ensure the traceability of pharmaceuticals. Article 37 A pharmaceutical marketing authorization holder shall establish an annual reporting system and annually report the production and sale of pharmaceuticals, post-market research, risk management, and other information to the medical products administration of the people's government of the province, autonomous region, or municipality directly under the Central Government. Article 38 Where a pharmaceutical marketing authorization holder is an overseas enterprise, a corporate enterprise in China it designates shall perform the obligation of the pharmaceutical marketing authorization holder and be subject to joint and several liability with the pharmaceutical marketing authorization holder. Article 39 A Chinese medicinal herb slices producing enterprise shall perform the relevant obligations of a pharmaceutical marketing authorization holder, implement the whole-process management of the production and sale of Chinese medicinal herb slices, establish a traceability system for Chinese medicinal herb slices, and ensure the safety, effectiveness, and traceability of Chinese medicinal herb slices. Article 40 A pharmaceutical marketing authorization holder may transfer its marketing authorization of pharmaceuticals, with the approval of the medical products administration under the State Council. The transferee shall have capabilities for quality management, risk prevention and control, and payment of damages guaranteeing the safety, effectiveness, and quality controllability of pharmaceuticals and perform the obligations of a pharmaceutical marketing authorization holder. Chapter IV Pharmaceutical Production Article 41 One engaged in pharmaceutical production activities shall receive the approval of the medical products administration of the people's government of the province, autonomous region, or municipality directly under the Central Government where the activities are conducted and obtain a pharmaceutical production license. Without a pharmaceutical production license, no pharmaceuticals may be produced. The pharmaceutical production license shall bear the scope of production and a period of validity, and upon expiration a new license shall be issued after examination for its renewal. Article 42 One engaged in pharmaceutical production activities shall meet the following conditions: (1) It shall be staffed with legally certified pharmacy technicians, engineering technical personnel, as well as corresponding skilled workers. (2) It shall have factory premises, facilities and a sanitary environment suitable for the pharmaceutical production. (3) It shall have a unit or competent personnel capable of inspecting the quality of the pharmaceuticals produced, as well as necessary instruments and equipment. (4) It shall have rules and systems assuring pharmaceutical quality and comply with the requirements of the Good Manufacturing Practices for Pharmaceuticals developed by the medical products administration under the State Council according to this Law. Article 43 One engaged in pharmaceutical production activities shall comply with the Good Manufacturing Practices for Pharmaceuticals, establish and improve a quality management system for pharmaceutical production, and ensure that the entire process of pharmaceutical production continues to meet statutory requirements. The legal representative or principal person in charge of a pharmaceutical producing enterprise shall be fully responsible for the pharmaceutical production activities of the enterprise. Article 44 Pharmaceuticals shall be produced in accordance with the technological procedures confirmed by the medical products administration under the State Council. The records of production and inspection shall be complete and accurate, and may not be fabricated. Chinese medicinal herb slices shall be processed according to the national pharmaceutical standards; and in the absence of such standards, the process must conform to the processing standards stipulated by the medical products administration of the provinces, autonomous regions, or municipalities directly under the central government. The processing standards stipulated by the medical products administration of the provinces, autonomous regions, or municipalities directly under the central governments shall be placed on record at the medical products administration under the State Council. In the case of inconformity with the national pharmaceutical standards or processing lacking conformity with the processing standards developed by the medical products administration of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government, neither delivery nor sale shall be made. Article 45 Active ingredients and inactive ingredients necessary for the production of pharmaceuticals shall conform to the requirements for medicinal use and the relevant requirements of the Good Manufacturing Practices for Pharmaceuticals. For the production of pharmaceuticals, a supplier of active ingredients or inactive ingredients shall be reviewed as required to ensure that the active ingredients or inactive ingredients purchased and used meet the requirements of the preceding paragraph. Article 46 Packaging materials and containers in direct contact with pharmaceuticals shall conform to the requirements for medicinal use and meet the standards for guaranteeing human health and safety. The medical products administrations shall stop the use of those unqualified packaging materials and containers which have direct contact with the pharmaceuticals. Article 47 A pharmaceutical producing enterprise shall conduct quality inspections on pharmaceuticals. In the case of inconformity with the national pharmaceutical standards, no delivery shall be made. A pharmaceutical producing enterprise shall establish rules and procedures for pharmaceutical delivery clearances and specify standards and conditions for delivery clearances. If the standards and conditions are met, delivery may be cleared only after the qualified person has signed. Article 48 Packages of pharmaceuticals shall meet the requirements for pharmaceutical quality and facilitate their storage, transportation, and medical use. Chinese medicinal materials shall be packaged before transportation. There shall appear on the package the name of the medicine, place of production, date, supplier, and an indication showing that the quality of the medicine is up to standard. Article 49 Packages of pharmaceuticals shall be labeled and include directions for use in accordance with the regulations. The label or directions shall indicate the generic name of the medicine, components, specifications, marketing authorization holder and its address, the producer and its address, registration number, batch number of the product, production date, expiry date, indications or major functions, directions for use, dosage, restrictions, adverse reactions and precautions. The words in the label and the directions for use shall be clear, and the production date, expiry date, and other matters shall be marked conspicuously and easily recognizable. Special indications shall be printed as required on the labels and directions for use of narcotics, psychotropic substances, toxic drugs for medical use, radioactive drugs, pharmaceuticals for external use and non-prescriptive pharmaceuticals. Article 50 Personnel in pharmaceutical marketing authorization holders, pharmaceutical producing or trading enterprises and in medical institutions who have direct contact ......