People's Republic of China (PRC) Drug Administration Law (revised on 20 19)

Chapter I General Provisions Article 1 This Law is formulated with a view to strengthening drug administration, ensuring drug quality, safeguarding the safety and legitimate rights and interests of the public in drug use and protecting and promoting public health. Article 2 This Law shall apply to the research, production, trading, use, supervision and administration of drugs within the territory of People's Republic of China (PRC).

Drugs mentioned in this Law refer to substances used for preventing, treating and diagnosing human diseases, purposefully regulating human physiological functions, and specifying indications or functional indications, usage and dosage, including traditional Chinese medicines, chemicals and biological products. Article 3 Drug management should focus on people's health, adhere to the principles of risk management, whole-process control and social governance, establish a scientific and strict supervision and management system, comprehensively improve the quality of drugs, and ensure the safety, effectiveness and accessibility of drugs. Article 4 The state develops modern medicine and traditional medicine and gives full play to their roles in prevention, medical treatment and health care.

The state protects wild medicinal resources and varieties of traditional Chinese medicine, and encourages the cultivation of genuine medicinal materials. Article 5 The State encourages the research and development of new drugs and protects the legitimate rights and interests of citizens, legal persons and other organizations in the research and development of new drugs. Article 6 The State implements the drug marketing license holder system for drug administration. The holder of the drug marketing license is responsible for the safety, effectiveness and quality controllability of the whole process of drug research and development, production, management and use according to law. Article 7 In the research and development, production, marketing and use of drugs, laws, regulations, rules, standards and norms shall be observed to ensure the truthfulness, accuracy, completeness and traceability of the information in the whole process. Article 8 The drug supervision and administration department of the State Council is in charge of drug supervision and administration throughout the country. The relevant departments of the State Council are responsible for drug supervision and administration within their respective functions and duties. The drug supervision and administration department of the State Council cooperates with the relevant departments of the State Council to implement the national drug industry development plan and industrial policy.

The pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the pharmaceutical supervisory and administrative work within their respective administrative areas. The departments responsible for drug supervision and administration of the people's governments at the city or county level divided into districts (hereinafter referred to as drug supervision and administration departments) shall be responsible for drug supervision and administration within their respective administrative areas. The relevant departments of the local people's governments at or above the county level shall be responsible for drug supervision and administration within the scope of their respective duties. Article 9 The local people's governments at or above the county level shall be responsible for the drug supervision and administration within their respective administrative areas, uniformly lead, organize and coordinate the drug supervision and administration and the response to drug safety emergencies within their respective administrative areas, and establish and improve the working mechanism of drug supervision and administration and the information sharing mechanism. Article 10 The people's governments at or above the county level shall incorporate the drug safety work into the national economic and social development plan at the corresponding level, incorporate the drug safety work funds into the fiscal budget of the government at the corresponding level, strengthen the capacity building of drug supervision and management, and provide guarantee for the drug safety work. Eleventh pharmaceutical professional and technical institutions established or designated by the pharmaceutical supervisory and administrative departments shall undertake the review, inspection, verification, monitoring and evaluation required for the implementation of pharmaceutical supervision and administration according to law. Article 12 The State shall establish and improve the drug traceability system. The drug supervision and administration department of the State Council shall formulate unified standards and norms for drug traceability, promote the mutual sharing of drug traceability information, and realize drug traceability.

The state establishes a pharmacovigilance system to monitor, identify, evaluate and control adverse drug reactions and other harmful reactions related to drug use. Thirteenth people's governments at all levels and their relevant departments, pharmaceutical industry associations, etc. We should strengthen the publicity and education of drug safety and carry out the popularization of drug safety laws and regulations.

The news media should carry out public welfare publicity on the knowledge of drug safety laws and regulations, and supervise drug violations by public opinion. Drug publicity and reporting should be comprehensive, scientific, objective and fair. Fourteenth pharmaceutical industry associations should strengthen industry self-discipline, establish and improve industry norms, promote the construction of industry credit system, guide and urge members to carry out activities such as drug production and operation according to law. Fifteenth people's governments at or above the county level and their relevant departments shall, in accordance with the relevant provisions of the state, commend and reward units and individuals that have made outstanding contributions in drug research, production, management, use and supervision and management. Chapter II Drug Development and Registration Article 16 The State supports drug innovation that is guided by clinical value and has definite or special curative effect on human diseases, encourages the development of new drugs with new therapeutic mechanism and multi-target systematic regulation and intervention on serious life-threatening diseases or rare diseases, and promotes the progress of drug technology.

The state encourages the use of modern science and technology and traditional Chinese medicine research methods to carry out scientific and technological research and drug development of traditional Chinese medicine, establish and improve a technical evaluation system that conforms to the characteristics of traditional Chinese medicine, and promote the inheritance and innovation of traditional Chinese medicine.

The state takes effective measures to encourage the research and innovation of children's medication, supports the development of new varieties, dosage forms and specifications of children's medication that meet their physiological characteristics, and gives priority to the examination and approval of children's medication. Seventeenth engaged in drug development activities, should abide by the quality management norms of drug non-clinical research and drug clinical trials, to ensure that the whole process of drug development continues to meet the statutory requirements.

Quality management standards for non-clinical research and clinical trials of drugs shall be formulated by the drug supervision and administration department of the State Council in conjunction with relevant departments of the State Council.