155! The full text of the new version of drug administration law is officially released and will be implemented from December 1!

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, in accordance with the amendment of the marine environment protection law of the people's Republic of China, etc adopted at the 6th meeting of the Standing Committee of the Twelfth National People's Congress on December 28, 2013 The decision of the seven laws was amended for the first time according to the decision on Amending the drug administration law of the people's Republic of China at the 14th meeting of the Standing Committee of the 12th National People's Congress on April 24, 2015, and Chapter I of the revised catalogue at the 2nd meeting of the 12th meeting of the Standing Committee of the 13th National People's Congress on August 26, 2019 Chapter II General Provisions Chapter II drug development and registration Chapter III drug listing license holder Chapter IV drug production Chapter V drug distribution Chapter VI Pharmaceutical Administration of medical institutions Chapter VII post marketing administration Chapter VIII drug price and advertisement Chapter IX drug reserve and supply Chapter X Supervision and administration Chapter XI Legal Responsibility Chapter XII supplementary provisions chapter I General Provisions Article 1 This law is formulated for the purpose of 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 activities of drug research and development, production, trade, use, supervision and administration within the territory of the people's Republic of China "Drugs" as mentioned in this Law refer to substances used to prevent, treat and diagnose human diseases, purposefully regulate human physiological functions and prescribe indications or functions, usage and dosage, including traditional Chinese medicine, chemical drugs and biological products Article 3 Drug Administration shall focus on people's health, adhere to the principles of risk management, whole process control and social co governance, establish a scientific and strict 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 and give full play to its role in prevention, medical treatment and health care The state protects the resources and varieties of wild medicinal materials and encourages the cultivation of genuine Chinese 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 applies the system of drug listing license holders to drug administration The holder of the drug listing license shall be responsible for the safety, effectiveness and quality controllability of the drug in the whole process of drug development, production, marketing and use according to law Article 7 in the development, production, marketing and use of drugs, laws, regulations, rules, standards and norms shall be observed to ensure the authenticity, accuracy, integrity and traceability of the information in the whole process Article 8 the drug regulatory department under the State Council shall be in charge of the national drug regulatory work The relevant departments under the State Council shall be responsible for the supervision and administration of drugs within the scope of their respective functions and responsibilities The drug regulatory department under the State Council shall cooperate with the relevant departments under the State Council to implement the national drug industry development plan and industrial policies 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 supervision and administration of pharmaceuticals within their respective administrative areas The departments (hereinafter referred to as "drug supervision and administration departments") of the people's governments at the level of cities divided into districts and at the county level that undertake the responsibilities of drug supervision and administration shall be responsible for the 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 the supervision and administration of drugs 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 regions, lead, organize and coordinate the drug supervision and administration within their respective administrative regions and the response to drug safety emergencies, and establish and improve the mechanism of drug supervision and administration and the mechanism of information sharing Article 10 the people's governments at or above the county level shall incorporate drug safety work into the national economic and social development plans at the corresponding levels, include the funds for drug safety work into the budgets of the governments at the corresponding levels, strengthen the construction of drug supervision and administration capacity, and provide guarantee for drug safety work Article 11 the pharmaceutical specialized technical institutions set up or designated by the pharmaceutical supervisory and administrative departments shall undertake the review, inspection, verification, monitoring and evaluation required for the implementation of the pharmaceutical supervisory and administrative work in accordance with the law Article 12 the State shall establish and improve the drug traceability system The drug regulatory department under the State Council shall formulate unified standards and specifications for drug traceability, promote the exchange and 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 drug-related harmful reactions Article 13 people's governments at all levels and their relevant departments, pharmaceutical industry associations, etc shall strengthen the publicity and education of drug safety, and carry out the popularization of the knowledge of drug safety laws and regulations News media shall carry out public welfare publicity of drug safety laws and regulations and other knowledge, and conduct public opinion supervision over drug violations The publicity and report on drugs shall be comprehensive, scientific, objective and fair Article 14 pharmaceutical industry associations shall strengthen industry self-discipline, establish and improve industry norms, promote the construction of industry integrity system, guide and urge members to carry out pharmaceutical production and marketing activities 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, commend and reward the units and individuals that have made outstanding contributions to the research, production, marketing, use, supervision and administration of drugs Chapter II drug development and registration Article 16 The State supports drug innovation oriented by clinical value, with definite or special curative effect on human diseases, encourages the development of new drugs with new treatment mechanism, treatment of serious life-threatening or rare diseases, multi-target and systematic regulation and intervention function on human body, 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 the technical evaluation system in line with the characteristics of traditional Chinese medicine, and promote the inheritance and innovation of traditional Chinese medicine The State shall take effective measures to encourage the development and innovation of children's drugs, support the development of new varieties, dosage forms and specifications of children's drugs that conform to children's physiological characteristics, and give priority to the review and approval of children's drugs Article 17 when engaging in drug research and development activities, we shall abide by the quality management standards for non clinical drug research and clinical drug trials, so as to ensure that the whole process of drug research and development continues to meet the legal requirements The drug regulatory department under the State Council, together with the relevant departments under the State Council, shall formulate the quality management standards for non clinical drug research and clinical drug trials Article 18 to carry out non clinical drug research, it shall conform to the relevant provisions of the state, have personnel, sites, equipment, instruments and management systems suitable for the research project, and ensure the authenticity of relevant data, materials and samples Article 19 to carry out clinical trials of drugs, relevant data, data and samples such as research methods, quality indicators, pharmacological and toxicological test results shall be truthfully submitted in accordance with the provisions of the drug regulatory department under the State Council and approved by the drug regulatory department under the State Council The drug regulatory department under the State Council shall, within 60 working days from the date of acceptance of the clinical trial application, decide whether to approve and notify the clinical trial applicant If it fails to notify within the time limit, it shall be deemed as approval Among them, the bioequivalence test shall be reported to the drug regulatory department under the State Council for the record Clinical trials of drugs shall be conducted in clinical trial institutions with corresponding conditions The drug clinical trial institutions shall be subject to the record keeping administration, and the specific measures shall be jointly formulated by the drug regulatory department under the State Council and the competent health department under the State Council Article 20 the clinical trials of drugs shall be conducted in accordance with the ethical principles, and a clinical trial plan shall be formulated, which shall be examined and approved by the ethics committee The ethics committee shall establish an ethics review system to ensure that the ethical review process is independent, objective and fair, to supervise and standardize the development of drug clinical trials, to protect the legitimate rights and interests of the subjects, and to safeguard the social and public interests Article 21 in the implementation of a clinical trial of drugs, detailed information such as the purpose and risks of the clinical trial shall be truthfully explained and explained to the subject or his guardian, the informed consent signed voluntarily by the subject or his guardian shall be obtained, and effective measures shall be taken to protect the legitimate rights and interests of the subject Article 22 in case of safety problems or other risks found during the clinical trial of drugs, the sponsor of the clinical trial shall timely adjust the clinical trial scheme, suspend or terminate the clinical trial, and report to the drug regulatory department under the State Council When necessary, the drug regulatory department under the State Council may order the adjustment of the clinical trial scheme, suspension or termination of the clinical trial Article 23 for drugs that are being used in clinical trials to treat diseases that are seriously life-threatening and have no effective means of treatment, which may benefit from medical observation and conform to ethical principles, they can be used for other patients with the same condition in the institutions carrying out clinical trials after examination and informed consent Article 24 a drug listed in China shall be approved by the drug regulatory department under the State Council and obtain a drug registration certificate, except for the traditional Chinese medicinal materials and pieces of decoction of traditional Chinese medicine that have not been subject to the examination and approval The catalogue of varieties of Chinese medicinal materials and Chinese Herbal Pieces subject to examination and approval shall be formulated by the drug regulatory department under the State Council jointly with the competent department of Chinese medicine under the State Council In applying for drug registration, authentic, sufficient and reliable data, materials and samples shall be provided to prove the safety, effectiveness and quality controllability of drugs Article 25 the pharmaceutical supervisory and administrative department under the State Council shall organize pharmaceutical, medical and other technical personnel to review the application for registration of pharmaceuticals, and examine the safety, effectiveness and quality controllability of pharmaceuticals, as well as the applicant's capabilities in quality management, risk prevention and control and liability compensation; if the application meets the requirements, a pharmaceutical registration certificate shall be issued When examining and approving drugs, the drug regulatory department under the State Council shall review and approve the chemical raw materials, relevant auxiliary materials, packaging materials and containers in direct contact with drugs, and the quality standards, production processes, labels and instructions of drugs The term "auxiliary materials" 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 serious life-threatening diseases without effective means of treatment and urgently needed drugs in public health, if the data of clinical trials of drugs have shown the efficacy and can predict the clinical value of the drugs, conditional approval may be attached, and relevant matters shall be clearly stated in the drug registration certificate Article 27 the drug regulatory department under the State Council 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 conclusion and basis of the review of the approved drugs shall be made public according to law and subject to social supervision The trade secrets known in the review and approval shall be kept confidential Article 28 drugs shall conform to the national drug standards If the drug quality standard approved by the drug regulatory department under the State Council is higher than the national drug standard, the approved drug quality standard shall prevail; if there is no national drug standard, the approved drug quality standard shall prevail Drug administration under the State Council