Order of the President of the People's Republic of China

No. 31

The Drug Administration Law of the People's Republic of China adopted at the 12th Meeting of the Standing Committee of the Thirteenth National People's Congress on August 26, 2019 is hereby promulgated and shall go into effect as of December 1, 2019.

Xi Jinping

President of the People's Republic of China

August 26, 2019

Drug Administration Law of the People's Republic of China

(Adopted at the 7th Meeting of the Standing Committee of the Sixth National People's Congress on September 20, 1984; revised for the first time at the 20th Meeting of the Standing Committee of the Ninth National People's Congress on February 28, 2001; amended for the first time in accordance with the Decision on Revising Seven Laws Including the Marine Environmental Protection Law of the People's Republic of China adopted at the 6th Meeting of the Standing Committee of the Twelfth National People's Congress on December 28, 2013; amended for the second time in accordance with the Decision on Revising the Drug Administration Law of the People's Republic of China adopted at the 14th Meeting of the Standing Committee of the Twelfth National People's Congress on April 24, 2015; revised for the second time at the 12th Meeting of the Standing Committee of the Thirteenth National People's Congress on August 26, 2019)

Contents

Chapter I General Provisions

Chapter II Research and Development and Registration

Chapter III Marketing Authorization Holder

Chapter IV Manufacturing

Chapter V Distribution

Chapter VI Pharmacy Administration in Medical Institutions

Chapter VII Post-marketing Management

Chapter VIII Pricing and Advertising

Chapter IX Stockpile and Supply

Chapter X Regulation

Chapter XI Legal Liability

Chapter XII Supplementary Provisions

Chapter I

General Provisions

Article 1 This Law is enacted to strengthen drug administration, ensure drug quality, protect drug safety and legitimate rights and interests of the public, and protect and promote public health.

Article 2 This Law shall apply to activities involving drug development, manufacturing, distribution, and use, and drug regulation in the territory of the People's Republic of China.

Drugs in this Law refer to substances used in the prevention, treatment, and diagnosis of human diseases and intended for the physiological regulation of the body's functions, for which indications or functions, dosage, and administration are stipulated, including traditional Chinese medicines, chemical drugs and biological products.

Article 3 Drug administration shall focus on public health, adhere to the principle of risk management, whole chain supervision, and social co-governance, establish a scientific and strict supervision and administration system, comprehensively improve drug quality, and ensure the safety, effectiveness and accessibility of drugs.

Article 4 The State develops both modern and traditional medicines to give full play to their role in prevention and treatment of diseases and in the maintenance of health. 

The State protects the resources of crude drugs and traditional Chinese medicines and encourages cultivation of traditional Chinese herbs.

Article 5 The State encourages research and development of new drugs, and protects the legitimate rights and interests of citizens, legal bodies and other institutions in research and development of new drugs.

Article 6 The State implements a marketing authorization holder (MAH) system for drug administration. Drug MAHs shall be legally responsible for drug safety, efficacy, and quality management throughout the process of drug research and development, manufacturing, distribution, and use.

Article 7 The conduct of drug research and development, manufacturing, distribution and use shall comply with applicable laws, regulations, standards and norms, to ensure the authenticity, accuracy, integrity and traceability of information throughout the process.

Article 8 The drug regulatory department under the State Council shall be responsible for drug administration nationwide. The relevant departments under the State Council shall be responsible for the related administrative work within the scope of their duties. The drug regulatory department under the State Council shall cooperate with relevant departments under the State Council in implementing national drug development programs and policies.

The drug regulatory departments of the people's governments of provinces, autonomous regions, or municipalities directly under the central government shall be responsible for drug administration in their administrative areas. The departments in charge of drug administration (hereinafter referred to as the drug regulatory departments) of the people's governments of municipalities divided into districts or of counties shall be responsible for drug administration in their administrative areas. The relevant departments of the people's governments at or above the county level shall be responsible for the related administrative work within the scope of their duties.

Article 9 The local people's governments at or above the county level shall be responsible for the work of drug administration in their administrative areas. They shall lead, organize, and coordinate the work of drug administration within their respective administrative areas as well as the response to drug safety emergencies. They shall establish and improve the drug administration work mechanism and an information-sharing system.

Article 10 The people's governments at or above the county level shall incorporate the work of drug safety into the economic and social development plans of the people at their levels, and include funds for drug safety in their government budgets, strengthen the capacity-building of drug administration, and provide safeguards for drug safety work.

Article 11 The drug professional and technical institutions established or designated by drug regulatory departments shall perform review, testing, inspection, monitoring and assessment as required by the conduct of drug administration in accordance with the law.

Article 12 The State establishes and improves the drug traceability system. The drug regulatory department under the State Council shall formulate unified drug traceability standards and norms and facilitate communication and sharing of drug traceability information to achieve drug traceability.

The State establishes the pharmacovigilance system to monitor, detect, assess and control adverse reactions or other harmful reactions related to use of drugs.

Article 13 The people's governments and their relevant departments at all levels and drug industry associations shall strengthen the publicity and education of drug safety, and work for the popularization of knowledge on laws and regulations of drug safety.

The news media shall publicize knowledge on relevant laws and regulations of drug safety and carry out public opinion supervision over unlawful acts relating to drugs. The coverage and reporting of drugs shall be comprehensive, appropriate, objective, and fair.

Article 14 Drug industry associations shall strengthen industry self-discipline, establish and improve industrial standards, strengthen the industrial integrity system, and guide and urge member enterprises to manufacture and distribute drugs in accordance with applicable laws.

Article 15 Entities and individuals that have made significant contributions to drug development, manufacturing, distribution, use and supervision and administration shall be commended and rewarded by the people's government and its relevant departments at or above the county level in accordance with the relevant provisions of the State.

Chapter II

Research and Development and Registration

Article 16 The State supports innovation in drug development which is guided by clinical value and has clear or specific therapeutic effect on human diseases, encourages research and development of new drugs with new therapeutic mechanisms, treats serious life-threatening or rare diseases, makes use of targeted and systemic regulatory interventions for humans, and promotes technological advancement in drug development.

The State encourages the use of modern science and technology and conventional methods in the research and development of traditional Chinese medicines, establishes and improves a technical evaluation system that is applicable to the characteristics of traditional Chinese medicines, and promotes inheritance and innovation of traditional Chinese medicines.

The State takes effective measures to encourage research and development and innovation of pediatric drugs, support the development of new varieties, dosage forms, and strengths of pediatric drugs according to pediatric physiological requirements, and prioritizes review and approval of pediatric drugs.

Article 17 Drug research and development activities shall comply with the Good Laboratory Practice for Non-Clinical Studies (GLP) and the Good Clinical Practice (GCP), and the entire drug research and development process shall continuously comply with statutory requirements. 

The drug regulatory department under the State Council jointly with relevant departments under the State Council shall formulate the GLP and GCP.

Article 18 The conduct of non-clinical studies for drugs shall meet the relevant provisions of the State, be equipped with proper personnel, field and laboratory equipment, instruments, and management systems relevant to the study, and ensure the authenticity of the data, documents, and samples.

Article 19 To conduct drug clinical trials, relevant data, documents, and samples, such as manufacturing process, quality specifications, and results of pharmacological and toxicological studies, shall be truthfully submitted in accordance with regulations of the drug regulatory department under the State Council and subject to its approval. The drug regulatory department under the State Council shall, within sixty working days from the date of acceptance of a clinical trial application, decide on whether to approve the application and notify the clinical trial sponsor. Where the sponsor is not notified within the stipulated period, the application shall be considered approved. Bioequivalence study applications shall be filed for record with the drug regulatory department under the State Council.

Clinical trials of drugs shall be conducted in clinical trial institutions that meet the relevant conditions. Drug clinical trial institutions are subject to record-keeping management, the specific measures for which shall be jointly formulated by the drug regulatory authorities under the State Council and the health authorities under the State Council.

Article 20 The conduct of drug clinical trials shall comply with ethical principles, with a clinical trial protocol developed, and be subject to review and approval by the ethics committee.

The ethics committee shall establish an ethics review system to ensure that the ethics review process is independent, objective, and fair, supervise the standard conduct of drug clinical trials, protect the legitimate rights and interests of trial subjects, and safeguard the public interest.

Article 21 When conducting a drug clinical trial, details such as the clinical trial objective and risks shall be truthfully stated and explained to the trial subjects or their guardians, an informed consent letter signed voluntarily by the trial subject or their guardian shall be obtained, and effective measures shall be taken to protect the lawful rights and interests of the trial subjects.

Article 22 Where safety issues or other risks are discovered during a drug clinical trial, the clinical trial sponsor shall promptly adjust the clinical trial protocol, suspend or terminate the clinical trial, and report to the drug regulatory department under the State Council. If necessary, the drug regulatory department under the State Council may order the sponsor to adjust the clinical trial protocol or suspend or end the clinical trial.

Article 23 For drugs that are undergoing clinical trials which are to be used for the treatment of severe life-threatening diseases for which there is no effective treatment, where it is concluded from medical observation that such drugs are beneficial and comply with ethical principles, the drugs may, after review and obtaining informed consent, be used on other patients with the same condition within the clinical trial institutions that are conducting the trial.

Article 24 Drugs to be marketed in the territory of the People's Republic of China shall be subject to approval by the drug regulatory department under the State Council to obtain the drug approval license, except for Chinese medicinal materials and prepared slices of Chinese crude drugs which are not subject to review and approval administration. The list of Chinese medicinal materials and prepared slices of Chinese crude drugs subject to review and approval shall be formulated by the drug regulatory department under the State Council jointly with the administrative department for traditional Chinese medicine under the State Council.

To apply for drug registration, data, documents, and samples that are true, adequate, and credible shall be provided to prove the safety, efficacy, and quality management of the drug.

Article 25 The drug regulatory department under the State Council shall organize experts in pharmaceutical, medical and other fields to review drug registration applications with regard to drug safety, efficacy and quality management as well as investigate the quality management, risk control and compensation for liability of the sponsor. Where the application meets the criteria, a drug approval license shall be issued.

During the review and approval of a drug application, the drug regulatory department under the State Council shall combine the review and approval of relevant chemical drug substances, the review of relevant excipients and immediate packaging materials and containers and the verification of its specification, manufacturing process, labeling and package insert.

Excipients in this Law refer to the vehicles and additives used for drug manufacturing and prescription dispensing.

Article 26 Drugs used for the treatment of severe life-threatening diseases for which there is no effective treatment and drugs urgently needed for public health, where the drug clinical trial data have shown their efficacy and predictable clinical results, may be conditionally approved, and the relevant information should be stated in the drug approval license.

Article 27 The drug regulatory department under the State Council shall optimize the drug review and approval work system, strengthen capacity building, establish and improve upon communication, provide an expert advisory mechanism, optimize the review and approval process, and enhance efficiency of review and approval.

The review conclusion and rationale for the approval of drug marketing shall be made public in accordance with the law. Commercial secrets accessed in the review and approval process shall be kept confidential.

Article 28 Drugs shall meet the national drug standards. Where a drug standard approved by the drug regulatory department exceeds the national drug standards, the approved standards shall be implemented. Where a national drug standard is not in place, relevant drugs shall follow the approved standards.

The Pharmacopoeia of the People's Republic of China and drug standards issued by the drug regulatory department under the State Council shall serve as the national drug standards.

The drug regulatory department under the State Council, in conjunction with the health department under the State Council, shall organize a Pharmacopoeia Commission, which is responsible for the formulation and revision of national drug standards.

The drug control institution set up or appointed by the drug regulatory department under the State Council shall be responsible for establishing the national standards for drug substances and reference materials. 

Article 29 A drug name listed in the national drug standards is an adopted name in China and may not be used as a trademark.

Chapter III

Marketing Authorization Holder

Article 30 A Marketing Authorization Holder (MAH) refers to an enterprise or R&D institution which holds a drug approval license.

MAHs shall, in accordance with provisions of this Law, be responsible for non-clinical studies, clinical trials, manufacture and distribution, post-marketing studies, and monitoring, reporting, and handling of adverse drug reactions. Other institutions and individuals engaged in activities, such as drug research and development, manufacture, distribution, storage, transportation, and use, shall assume corresponding responsibilities in accordance with the laws.

The legal representative and the principal responsible person of an MAH shall take full responsibility for drug quality.

Article 31 MAHs shall establish a drug quality assurance system and appoint dedicated personnel to take charge of drug quality management independently.

MAHs shall conduct audits on the quality management systems of the drug contract manufacturers and drug distributors on a regular basis to supervise and ensure their continuous capability of quality assurance and control.

Article 32 MAHs may either manufacture drug products by themselves or entrust a drug manufacturer with production. 

MAHs that manufacture their own drug products shall obtain a Drug Manufacturing Certificate in accordance with provisions of this Law. Where a drug is contracted out, the MAH shall entrust a qualified drug manufacturer. The MAH and the contract manufacture shall sign agreements on entrustment quality and shall comply with their obligations under the agreements.

The drug regulatory department under the State Council shall develop guidelines for the quality agreement of contracting out the manufacturing to provide guidance and supervision for MAHs and contract manufacturers to fulfill their obligations of drug quality assurance.

The contract manufacturing of blood products, narcotic drugs, psychotropic substances, toxic drugs for medical use, and pharmaceutical precursor chemicals is prohibited, unless otherwise stipulated by the drug regulatory department under the State Council.

Article 33 MAHs shall establish a marketing release procedure to audit drug products released by drug manufacturers. Drug products shall not be released until signed off by a qualified person and those that do not conform to national drug standards shall not be released.

Article 34 MAHs may either distribute drug products that have obtained drug approval licenses or entrust a drug distributor for distribution. MAHs engaged in drug retail activities shall obtain a Drug Distribution Certificate.

MAHs that distribute drugs shall meet the requirements stipulated in Article 52 of this Law. For distributors entrusted with distribution, a qualified distributor shall be used. The MAH and the entrusted distributor shall sign an entrustment agreement and shall comply with their obligations under the agreement.

Article 35 Where MAHs, drug manufacturers or drug distributors entrust a third party to store or transport drugs, they shall assess the entrusted party's quality assurance and risk management capacity, sign an entrustment agreement with the entrusted party to specify such things as drug quality responsibilities and operation procedures, and supervise the entrusted party.

Article 36 MAHs, drug manufacturers, drug distributors, and medical institutions shall establish and implement drug traceability systems and provide that information in accordance with regulations to ensure the traceability of drug products.

Article 37 MAHs shall establish an annual reporting system to report information including drug manufacturing and distribution, post-marketing studies, and risk management to the drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government in accordance with regulations.

Article 38 Where the MAH is an overseas enterprise, an enterprise legal person within the territory of the People's Republic of China shall be designated to fulfill the obligations of the MAH and assume joint liability with the MAH.

Article 39 Manufacturers of decoction pieces of Chinese medicine shall fulfill relevant obligations of an MAH, and shall implement whole chain management for the manufacture and distribution of decoction pieces of Chinese medicine and establish a traceability system for decoction pieces of Chinese medicine to ensure the safety, efficacy, and traceability thereof.

Article 40 An MAH may, upon approval by the drug regulatory department under the State Council, transfer its drug marketing authorization. The transferee shall be capable of quality management, risk control, and compensation for liability to ensure drug safety, efficacy and quality management, and shall fulfill the obligations of the MAH.

Chapter IV

Manufacturing

Article 41 The undertaking of drug manufacturing shall be subject to approval by the local drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the central government, and shall obtain a Drug Manufacturing Certificate. No one may manufacture drugs without the certificate.

The valid term and the scope of manufacturing shall be indicated in the Drug Manufacturing Certificate. For renewal of the certificate on expiration, reexamination is required.

Article 42 The undertaking of drug manufacturing shall meet the following requirements:

(1) have legally qualified pharmaceutical and engineering professionals as well as the necessary technical workers;

(2) have the premises, facilities, and hygienic environment required for drug manufacturing;

(3) have the institutions and personnel capable of meeting the quality control and testing requirements for drugs to be produced and the necessary instruments and equipment; and

(4) have rules and regulations in place to ensure the quality of drugs and comply with the requirements of the Good Manufacturing Practice for Pharmaceutical Products (GMP) formulated by the drug regulatory department under the State Council in accordance with this Law.

Article 43 The undertaking of drug manufacturing shall comply with the GMP.A quality management system shall be established and improved for drug manufacturing, to ensure that the whole chain of drug manufacturing continuously complies with statutory requirements.

The legal representative and the principal responsible person of a drug manufacturer shall be fully responsible for the drug manufacturing activities.

Article 44 A drug shall be made in accordance with the national drug standards and with production processes approved by the drug regulatory department under the State Council. The production and testing records shall be complete and correct and shall not be fabricated.

Decoction pieces of Chinese medicine shall be processed in accordance with the national drug standards. Those not contained in the standards shall be produced in accordance with the processing procedures formulated by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the central government. The said procedures shall be submitted to the drug regulatory department under the State Council for the record. Decoction pieces of Chinese medicine that do not meet the national drug standards or are not produced in accordance with the processing procedures formulated by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the central government shall not be released or distributed.

Article 45 The starting materials for the manufacturing of pharmaceutical products shall comply with the medicinal requirements and the relevant GMP. 

For drug manufacturing, the manufacturers shall audit the suppliers of drug substances and excipients, as required to ensure that purchases and use of the drug substances and excipients comply with the requirements stipulated in the preceding paragraph.

Article 46 Immediate packaging materials and containers shall meet the requirements for medicinal use and the standards for ensuring human health and safety.

Where the immediate packaging materials and containers are not up to standard, the drug regulatory department shall order a stop to the use of the materials and containers. 

Article 47 Drug manufacturers shall perform drug quality tests. Drugs that do not meet the national drug standards shall not be released.

Drug manufacturers shall establish drug release procedures and specify the release standards and criteria. Drug products that meet the standards and criteria shall be released upon signature by the qualified person.

Article 48 Drug packaging shall conform to drug quality requirements and be convenient for storage, transportation, and medical use.

Chinese medicinal materials shall be packed for transportation. Each package shall indicate the name of the drug, the origin of production, and the date and the name of the consignor, and include a quality certification mark.

Article 49 The drug package shall include a label together with a package insert as required by regulations.

The label or package insert shall indicate the adopted name of the drug in China, its ingredients and strength, the name and address of the MAH, the name and address of the manufacturer, approval number, product batch number, production date, date of expiration, indications or functions, dosage and administration, contraindications, adverse drug reactions, and precautions. The wording of the label and package insert shall be clear, and the production date and date of expiration shall be prominent and discernible.

Specified marks shall be printed on the label and package insert of narcotic drugs, psychotropic substances, toxic drugs for medical use, radioactive pharmaceuticals, drugs for topical use, and non-prescription drugs.

Article 50 Staff members of MAHs, drug manufacturers, drug distributors, and medical institutions who are in direct contact with drugs shall undergo annual health checkups. No one who suffers from infectious diseases or any other diseases which may contaminate drugs may engage in any work involving direct contact with drugs.