Adopted at the Seventh Meeting of the Standing Committee of the Sixth National People's Congress on September 20, 1984, and first revised at the 20th Meeting of the Standing Committee of the Ninth National People's Congress on February 28, 2001, in accordance with the "Amendment to the People's Republic of China" adopted at the Sixth Meeting of the Standing Committee of the Twelfth National People's Congress on December 28, 2013 The "Decision on the Marine Environmental Protection Law of the People's Republic of China" and Seven other Laws were first revised. The second revision was made in accordance with the "Decision on Amending the Drug Administration Law of the People's Republic of China" adopted at the 14th Meeting of the Standing Committee of the 12th National People's Congress on April 24, 2015. The 12th meeting of the Standing Committee of the 13th National People's Congress was held on August 26, 2019 Discuss the second revision
Table of Contents
Chapter One General Provisions
Chapter Two: Drug Development and Registration
Chapter Three Drug Marketing Authorization Holders
Chapter Four Pharmaceutical Production
Chapter Five Pharmaceutical Business
Chapter VI Pharmaceutical Administration of Medical Institutions
Chapter 7 Post-marketing Management of Drugs
Chapter Eight: Drug Prices and Advertisements
Chapter Nine Drug Reserves and Supplies
Chapter Ten Supervision and Management
Chapter Eleven Legal Liability
Chapter Twelve Supplementary Provisions
Chapter One General Provisions
Article 1 This Law is formulated for the purpose of strengthening the administration of drugs, ensuring the quality of drugs, 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 activities of research and development, production, operation, use and supervision and administration of drugs within the territory of the People's Republic of China.
The term "drugs" as used in this Law refers to substances used for the prevention, treatment and diagnosis of human diseases, with the purpose of regulating human physiological functions and with specified indications or main functions, usage and dosage, including traditional Chinese medicine, chemical drugs and biological products, etc.
Article 3 The management of drugs shall be centered on people's health, adhere to the principles of risk management, full-process control and social co-governance, establish a scientific and strict supervision and management system, comprehensively improve the quality of drugs, and ensure the safety, effectiveness and accessibility of drugs.
Article 4 The state shall develop modern and traditional medicines and give 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 Chinese medicinal materials.
Article 5 The state encourages the research and creation 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 a drug marketing authorization holder system for the administration of drugs. The marketing authorization holder of a drug is legally responsible for the safety, efficacy and quality controllability of the drug throughout the entire process of its research and development, production, operation and use.
Article 7 Those engaged in the research and development, production, operation and use of drugs shall abide by laws, regulations, rules, standards and norms, and ensure that the information throughout the process is true, accurate, complete and traceable.
Article 8 The drug regulatory department of The State Council shall be in charge of the drug regulatory work throughout the country. The relevant departments of The State Council are responsible for the supervision and administration related to drugs within their respective duties. The drug regulatory department of The State Council cooperates with relevant departments of The State Council to implement the national drug industry development plan and industrial policies.
The drug regulatory department of the people's government of a province, autonomous region or municipality directly under the Central Government is responsible for the drug regulatory work within its administrative region. The departments of the people's governments at the level of cities divided into districts and counties that undertake the duties of drug supervision and administration (hereinafter referred to as the drug supervision and administration departments) are responsible for the drug supervision and administration work within their respective administrative regions. The relevant departments of the people's governments at or above the county level shall be responsible for the supervision and administration related to drugs within their respective duties.
Article 9 The people's governments at or above the county level shall be responsible for the drug supervision and administration work within their administrative regions, and shall uniformly lead, organize and coordinate the drug supervision and administration work and the response to drug safety emergencies within their administrative regions, and establish and improve the drug supervision and administration work mechanism and information sharing mechanism.
Article 10 The people's governments at or above the county level shall incorporate drug safety work into their respective national economic and social development plans, include the funds for drug safety work in their respective government budgets, strengthen the capacity building for drug supervision and administration, and provide guarantees for drug safety work.
Article 11 The professional technical institutions for drugs established or designated by the drug regulatory department shall undertake the review, inspection, verification, monitoring and evaluation and other work required for the implementation of drug supervision and administration in accordance with the law.
Article 12 The state shall establish and improve the drug traceability system. The drug regulatory department of The State Council shall formulate unified standards and norms for drug traceability, promote the mutual sharing of drug traceability information, and achieve drug traceability.
The state establishes 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, pharmaceutical industry associations, etc. shall strengthen the publicity and education on drug safety and carry out the popularization of knowledge on drug safety laws and regulations.
News media should carry out public welfare publicity on knowledge such as drug safety laws and regulations, and conduct public opinion supervision over drug violations. Publicity and reporting on drugs should be comprehensive, scientific, objective and fair.
Article 14 The pharmaceutical industry association shall strengthen self-discipline within the industry, establish and improve industry norms, promote the construction of an industry integrity system, and guide and urge its members to carry out activities such as drug production and operation in accordance with the law.
Article 15 The people's governments at or above the county level and their relevant departments shall, in accordance with the relevant provisions of the state, give commendation and rewards to units and individuals who have made outstanding contributions in the research and development, production, operation, use and supervision and administration of drugs.
Chapter Two: Drug Development and Registration
Article 16 The state supports drug innovation that is oriented towards clinical value and has clear or special therapeutic effects on human diseases, encourages the research and development of new drugs with new therapeutic mechanisms, for treating serious life-threatening diseases or rare diseases, and for having multi-targeted systemic regulatory and intervention functions on the human body, and promotes the progress of drug technology.
The state encourages the application of modern science and technology as well as traditional Chinese medicine research methods to conduct scientific and technological research on traditional Chinese medicine and drug development, 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 medicines for children, supports the development of new varieties, dosage forms and specifications of medicines for children that conform to the physiological characteristics of children, and gives priority to the review and approval of medicines for children.
Article 17 When engaging in drug research and development activities, one shall abide by the Good Clinical Practice for Non-clinical Research of Drugs and the Good Clinical Practice for Clinical Trials of Drugs, and ensure that the entire process of drug research and development continuously meets the legal requirements.
Good Manufacturing Practice for Non-clinical Research of Drugs and Good Manufacturing Practice for Clinical Trials of Drugs shall be formulated by the drug regulatory department of The State Council in conjunction with the relevant departments of The State Council.
Article 18 When conducting non-clinical research on drugs, it shall comply with relevant national regulations, have personnel, venues, equipment, instruments and management systems commensurate with the research project, and ensure the authenticity of relevant data, materials and samples.
Article 19 When conducting clinical trials of drugs, relevant data, materials and samples such as the research and development methods, quality indicators, pharmacological and toxicological test results shall be truthfully submitted in accordance with the regulations of the drug regulatory department of The State Council and approved by the drug regulatory department of The State Council. The drug regulatory department of The State Council shall, within 60 working days from the date of accepting the application for clinical trials, decide whether to approve and notify the sponsor of the clinical trial. Failure to notify within the time limit shall be deemed as approval. Among them, those conducting bioequivalence tests shall be filed with the drug regulatory department of The State Council.
Drug clinical trials should be conducted in clinical trial institutions that have the corresponding conditions. Drug clinical trial institutions are subject to filing management. The specific measures shall be jointly formulated by the drug regulatory department of The State Council and the competent department of health and wellness of The State Council.
Article 20 The conduct of drug clinical trials shall comply with ethical principles, formulate a clinical trial protocol, and be reviewed and approved by the ethics committee.
The ethics committee should establish an ethics review work system to ensure that the ethics review process is independent, objective and fair, supervise and standardize the conduct of drug clinical trials, safeguard the legitimate rights and interests of the subjects, and protect the public interests of society.
Article 21 When conducting drug clinical trials, the subjects or their guardians shall be truthfully informed and explained of the detailed circumstances such as the purpose and risks of the clinical trials, and an informed consent form voluntarily signed by the subjects or their guardians shall be obtained. Effective measures shall be taken to protect the legitimate rights and interests of the subjects.
Article 22 During the clinical trial of a drug, if any safety issues or other risks are discovered, the sponsor of the clinical trial shall promptly adjust the clinical trial protocol, suspend or terminate the clinical trial, and report to the drug regulatory department of The State Council. When necessary, the drug regulatory department of The State Council may order the adjustment of the clinical trial protocol, the suspension or termination of the clinical trial.
Article 23 For drugs that are undergoing clinical trials for the treatment of serious life-threatening diseases for which there are no effective treatment methods, if they may benefit from medical observation and comply with ethical principles, they may be used in other patients with the same condition within the institution where the clinical trials are conducted after review and informed consent.
Article 24 Drugs marketed within the territory of China shall be approved by the drug regulatory department of The State Council and obtain a drug registration certificate; However, this does not apply to Chinese medicinal materials and Chinese herbal decoction pieces that have not been subject to approval management. The list of varieties of Chinese medicinal materials and Chinese herbal decoction pieces subject to approval management shall be formulated by the drug regulatory department of The State Council in conjunction with the competent department of traditional Chinese medicine of The State Council.
When applying for drug registration, one should provide true, sufficient and reliable data, materials and samples to prove the safety, efficacy and quality controllability of the drug.
Article 25 For the drugs applied for registration, the drug regulatory department of The State Council shall organize pharmacists, medical professionals and other technical personnel to conduct reviews, and examine the safety, efficacy and quality controllability of the drugs, as well as the quality management, risk prevention and control and liability compensation capabilities of the applicants. Those who meet the conditions will be issued a drug registration certificate.
When the drug regulatory department of The State Council approves drugs, it reviews and approves chemical raw materials at the same time, reviews and approves related excipients, packaging materials and containers that come into direct contact with drugs at the same time, and approves the quality standards, production processes, labels and instructions of drugs at the same time.
The term "excipients" as used in this Law refers to excipients and additives used in the production of drugs and the dispensing of prescriptions.
Article 26 For the treatment of diseases that seriously endanger life and for which there are no effective treatment methods, as well as drugs urgently needed in public health, if the clinical trial data of the drug have shown efficacy and its clinical value can be predicted, conditional approval may be granted, and the relevant matters shall be stated in the drug registration certificate.
Article 27 The drug regulatory department of The State Council shall improve the working system for drug review and approval, strengthen capacity building, establish and improve communication and exchange, expert consultation and other mechanisms, optimize the review and approval process, and enhance the efficiency of review and approval.
The review conclusions and basis of approved drugs for marketing shall be made public in accordance with the law and subject to social supervision. Business secrets known during the review and approval process shall be kept confidential.
Article 28 Drugs shall conform to the national drug standards. Where the drug quality standards approved by the drug regulatory department of The State Council are higher than the national drug standards, the approved drug quality standards shall be followed. Where there is no national drug standard, it shall comply with the approved drug quality standard.
The "Pharmacopoeia of the People's Republic of China" and drug standards promulgated by the drug regulatory department of The State Council are national drug standards.
The drug regulatory department of The State Council, in conjunction with the competent department of health and wellness of The State Council, organizes the Pharmacopoeia Committee to be responsible for the formulation and revision of national drug standards.
The drug inspection institutions established or designated by the drug regulatory department of The State Council are responsible for calibrating national drug reference standards and control substances.
Article 29 The names of drugs included in the national drug standards shall be the generic names of drugs. If a name has already been used as a generic name for a drug, it shall not be used as a drug trademark.
Chapter Three Drug Marketing Authorization Holders
Article 30 The marketing authorization holder of a drug refers to an enterprise or a drug research and development institution that has obtained a drug registration certificate, etc.
The marketing authorization holder of a drug shall, in accordance with the provisions of this Law, be responsible for the non-clinical research, clinical trials, production and operation, post-marketing research, adverse reaction monitoring, reporting and handling of the drug. Other units and individuals engaged in the research and development, production, operation, storage, transportation and use of drugs shall bear corresponding responsibilities in accordance with the law.
The legal representative and principal person in charge of the marketing authorization holder of a drug shall be fully responsible for the quality of the drug.
Article 31 The marketing authorization holder of a drug shall establish a drug quality assurance system and appoint dedicated personnel to be independently responsible for the quality management of the drug.
The marketing authorization holder of a drug shall conduct regular audits of the quality management systems of the entrusted drug manufacturing enterprises and drug trading enterprises, and supervise their continuous possession of quality assurance and control capabilities.
Article 32 The marketing authorization holder of a drug may produce the drug by itself or entrust a drug manufacturing enterprise to do so.
Where a drug marketing authorization holder produces drugs by itself, it shall obtain a drug production license in accordance with the provisions of this Law. Where production is entrusted, it shall be entrusted to a qualified drug manufacturing enterprise. The marketing authorization holder of a drug and the entrusted manufacturing enterprise shall enter into a entrustment agreement and a quality agreement, and strictly fulfill the obligations stipulated in the agreements.
The drug regulatory department of The State Council formulates guidelines for quality agreements on drug entrusted production to guide and supervise drug marketing authorization holders and entrusted production enterprises in fulfilling their obligations for drug quality assurance.
Blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use, and precursor chemicals for drug manufacture shall not be entrusted for production. However, this does not apply if otherwise stipulated by the drug regulatory department of The State Council.
Article 33 The marketing authorization holder of a drug shall establish a marketing release procedure for the drug, review the drugs released by the drug manufacturing enterprise from the factory, and release them only after obtaining the signature of the quality authorized person. Those that do not meet the national drug standards shall not be released.
Article 34 The marketing authorization holder of a drug may sell the drug for which it has obtained the drug registration certificate by itself or entrust a drug trading enterprise to do so. A drug marketing authorization holder who engages in drug retail activities shall obtain a drug business license.
Where a marketing authorization holder of a drug sells the drug on its own, it shall meet the conditions stipulated in Article 52 of this Law. Where sales are entrusted, they shall be entrusted to qualified drug trading enterprises. The marketing authorization holder of a drug and the entrusted operating enterprise shall enter into a commission agreement and strictly fulfill the obligations stipulated in the agreement.
the thirtieth
