英文译稿《中国药品管理法》2019版

1、Drug Administration Law of the Peoples Republic of China (2019 Revision)Promulgation Authorities:Standing Committee of the National People's Congress Promulgation Date:2019.08.26Effective Date: 2019.12.01Validity Status: forthcomingDocument Number: Presidential Decree No. 31Drug Administration L

2、aw of the People's Republic of China (2019 Revision)The revised Drug Administration Law of the People's Republic of China passed by the 12th Session of the Standing Committee of the 13th National People's Congress on 26 August 2019 is hereby promulgated and shall be implemented with effe

3、ct from 1 December 2019.26 August 2019Passed by the Seventh Session of the Standing Committee of the Sixth National People's Congress on 20 September 1984First amendment by the Twentieth Session of the Standing Committee of the Ninth National People's Congress on 28 February 2001First revisi

4、on on 28 December 2013 pursuant to the Decision of the Standing Committee of the National People's Congress on Revision of Seven Pieces of Legislation Including the "Marine Environmental Protection Law of the People's Republic of China" passed by the Sixth Session of the Standing C

5、ommittee of the Twelfth National People's CongressSecond revision on 24 April 2015 pursuant to the Decision on Revision of the "Drug Administration Law of the People's Republic of China" passed by the Fourteenth Session of the Standing Committee of the Twelfth National People's

6、 CongressSecond amendment by the Twelfth Session of the Standing Committee of the Thirteenth National People's Congress on 26 August 2019ContentChapter 1 General Principles3Chapter 2 Drug Research and Development and Registration4Chapter 3 Drug Marketing Authorization Holder 5Chapter 4 Drug Manu

7、facturing 7Chapter 5 Drug Distribution 8Chapter 6 Pharmacy Administration of Medical Institutions 10Chapter 7 Drug Post-marketing Management 11Chapter 8 Drug Pricing and Advertising 12Chapter 9 Drug Reserve and Supply 12Chapter 10 Supervision and Administration 13Chapter 11 Legal Liability 15Chapter

8、 12 Supplementary Provisions 21Chapter 1 General PrinciplesArticle 1 This Law is enacted for the purposes of strengthening drug administration, to ensure drug quality, protecting the public's medication safety and legitimate rights and interests, protecting and promoting public health.Article 2

9、This Law shall apply to drug research and development, manufacturing, distribution and use in the People's Republic of China and the supervision and administration activities thereof.Drugs referred to in the Law shall mean substances used for the prevention, treatment and diagnosis of human dise

10、ases and intended for the regulation of the physiological functions of human beings, for which indication, usage and dosage are stipulated, including traditional Chinese medicine, chemical medicine and biological products etc.Article 3 Drug administration shall focus on public health, adhere to the

11、principle of "risk management, whole process supervision, and social co-governance", establish a scientific and strict supervision and administration system, comprehensively improve drug quality, and ensure drug safety, efficacy and accessibility of drugs.Article 4 The State develops both

12、modern medicines and traditional medicines, to give full play to their role in prevention and treatment of diseases and in the health care.The State protects wild crud drugs and traditional Chinese medicine resources and encourages cultivation of genuine Chinese herbal medicine.Article 5 The State e

13、ncourages research and development of new drugs, and protects the legitimate rights and interests of citizens, legal persons and other organizations in research and development of new drugs.Article 6 The State implements marketing authorization holder system for drug administration. Drug marketing a

14、uthorization holders shall be responsible pursuant to the law for drug safety, efficacy and quality controllability throughout the drug research and development, manufacturing, distribution and use process.Article 7 The conduct of drug research and development, manufacturing, distribution, and use,

15、shall comply with applicable laws, regulations, standards and practices, to ensure the authenticity, accuracy, integrity and traceability of the whole-process data.Article 8 The drug administrative department under the State Council presides over the supervision and administration of drugs throughou

16、t the country. The relevant departments under the State Council are responsible for supervision and administration related to drug within their respective responsibilities. The drug administrative department under the State Council cooperates with the relevant departments under the State Council to

17、implement the drug industry development plans and industrial policies developed by the state.The drug regulatory authorities of the peoples government of a province, an autonomous region, or a municipality directly under the Central Government shall undertake the drug supervision and administration

18、within its administrative region. The department in charge of drug regulation under the peoples governments of a city or county that sets districts (hereinafter referred to as the "drug administrative department") shall be responsible for the drug supervision and administration within its

19、administrative region. The relevant departments underthe local peoples governments at o r above the county level shall be responsible for supervision and administration related to drug within their respective responsibilities.Article 9 The local people's governments at or above the county level

20、shall be responsible for the work of drug supervision and administration within their respective administrative regions. They shall lead, organize, and coordinate the work of drug supervision and administration within their respective administrative regions as well as response to drug safety emergen

21、cy. They shall establish and improve the work mechanism of drug supervision and administration, and the information sharing system.Article 10 The people's governments at or above the county level shall incorporate the work of drug safety into the plans for the economic and social development of

22、the people at the corresponding levels, and include funds for drug safety in their government budgets, strengthen the capacity-building of drug supervision, and provide safeguards for drug safety work.Article 11 Professional drug technology institutions established or designated by drug regulatory d

23、epartments perform review, testing, inspection, monitoring and evaluation as required by the conduct of drug supervision and administration according to law.Article 12 The State establishes and improves upon a drug traceability system. The drug administrative department of the State Council shall fo

24、rmulate unified drug traceability standards and regulations, propel mutual communication and sharing of drug traceability information, to achieve drug traceability.The State establishes a pharmacovigilance system to monitor, identify, evaluate and control adverse reactions or other adverse reactions

25、 related to drug usage drug.Article 13 The people's governments at all levels shall strengthen the publicity and education of drug safety, and carry out the popularization of knowledge on laws and regulations of drug safety.The new media shall publicize knowledge on relevant laws and regulations

26、 of drugs, and supervise unlawful acts concerning drugs by public opinions. The publicity and reporting about drugs shall be comprehensive, scientific, objective and fair.Article 14 Drug industry associations shall strengthen self-discipline, establish and improve industrial standard, promote the sy

27、stem construction of industrial integrity, guide and urge enterprises to manufacture and distribute drugs according to applicable laws.Article 15 Units and individuals that have made significant contributions to drug development, manufacturing, distri bution, use and supervision and administration s

28、hall be commended and rewarded by the peoples government and its relevant departments at or above the county level in according with relevant provisions.Chapter 2 Drug Research and Development and RegistrationArticle 16 The State supports innovation of new drugs which are guided by clinical value an

29、d have clear or special therapeutic effect on human diseases, encourages research and manufacture of drugs which have new therapeutic mechanisms, treat serious life-threatening diseases or rare diseases, and have multiple targeted systemic regulatory interventions for humans, and promotes technologi

30、cal advancement for drugs.The State encourages to utilize modern science and technology and traditional methods for traditional Chi nese medicine technology research and development, establishes and improves a technical evaluation system that is applicable to traditional Chinese medicine characteris

31、tics, and promotes Chinese medicine heritage and innovation.The State takes effective measures, encourages research and development and innovation of pediatric drugs, boosts development of new drugs, dosage forms and strengths of pediatric drugs which are in line with pediatric physiological feature

32、s, and prioritizes review and approval of pediatric drugs.Article 17 Drug research and development activities shall comply with Good Laboratory Practice(GLP), and Good Clinical Practice(GCP), and ensure that the whole drug research and development process continuously com ply with statutory requirem

33、ents. GLP and GCP shall be formulated by the drug administrative department of the State Council jointly with the relevant State Council departments.Article 18 Non-clinical studies for drugs shall comply with the relevant provisions of the State, with personnel, field, equipment, instruments and man

34、agement systems corresponding to the study, and ensure the authenticity of the data, documents and samples.Article 19 For drug clinical trials application, according to the provisions of the drug administrativ e department of the State Council, the applicant shall submit the relevant data, documents

35、 and samples such as research and development methods, specification, pharmacological and toxicological study results etc truthfully, and be subject to approval by thedrug administrative department of the State Council. The drug administrative department of the State Council shall, within 60 working

36、 days from the date of acceptance of a clinical trial application, decide on approval or not of the application and notify the clinical trial applicant; where the applicant is not notified within the stipulated period, the application shall be deemed approved. Bioequivalence study applications shall

37、 be filed for record to the drug administrative department of the State Council.Drug clinical trials shall be conducted at a clinical trial institution which meets the corresponding criteria. Drug clinical trial institutions shall be subject to record administration; detailed measures shall be formu

38、lated by the drug administrative department of the State Council jointly with the competent health administrative department of the State Council.Article 20 Conducting drug clinical trials shall comply with ethical principles, formulate a clinical trial protocol, and be subject to review and approva

39、l by ethics committee.The ethics committee shall establish an ethics review system, to ensure that the ethics review process is independent, objective and equitable, supervise standardized conduct of drug clinical trials, protect the legitima te rights and interests of trial subjects, and safeguard

40、public interest.Article 21 Conducting a drug clinical trial shall make truthful statement and explanation to the trial subjects or their guardians in regard to the details such as the clinical trial objective and risks, obtain an informed consent letter signedvoluntarily by the trial subject or his/

41、her guardian, and take effective measures to protect the lawful rights and interests of the trial subjects.Article 22 Where safety issues or other risks are discovered during the drug clinical trial period, the clinical trial applicant shall promptly adjust the clinical trial protocol, suspend or te

42、rminate the clinical trial, and report to the drug administra tive department of the State Council. Where necessary, the drug administrative department of the State Council may order the applicant to adjust the clinical trial protocol, suspend or terminate the clinical trial.Article 23 For drugs und

43、er clinical trial which are used for treatment of serious 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, such drug may be used within the clinical trial institution

44、 on other patients with the same condition upon review by ethics committee and obtaining informed consent.Article 24 Drugs marketed in China shall be subject to approval by the drug administrative department of the State Council, and obtain a drug approval license, except for traditional Chinese med

45、icinal herbs and traditional Chinese medicine preparations which are not subject to review and approval administration. The list of traditional Chinese medicinal herbs and traditional Chinese medicine preparations shall be formulated by the drug administrative department of the State Council jointly

46、 with the competent traditional Chinese medicine administrative department of the State Council.Applicants for drug registration shall provide true, adequate and credible data, documents and samples to prove the drug safety, efficacy and quality.Article 25 The drug administrative department of the S

47、tate Council shall organize CMC, clinical and other technical staff to review drug registration application on drug safety, efficacy and quality as well as quality management, risk control and liability compensation etc; where the application meets the criteria, a drug approval license shall be issu

48、ed.During the review and approval, the drug administrative department of the State Council shall combine the review and approval of the chemical drug substance, review of the excipients and primary packag ing materials with drug product approve the specification, manufacturing process, labeling and

49、leaflet.Excipients referred to in this Law shall mean the excipients and additives used in drug manufacturing and formulation.Article 26 For drug used for treatment of serious life-threatening diseases for which there is no effective treatment, as well as drugs urgently need for public health, where

50、 the drug clinical trial data to show efficacy and predictable clinical value. it can be conditionally approved, and the relevant information should be stated in the dug registration license.Article 27 The drug administrative department of the State Council shall optimize the drug review and approva

51、l work system, strengthen capability building, establish and improve upon communication, expert advisory mechanism etc, optimize the review and review and approval process, and improve the review and approva l productivity.The review conclusion and rational for drug marketing approval shall be discl

52、osed for public supervision pursuant to the law. Commercial secrets accessed in the review and approval shall be kept confidential.Article 28 Drugs on market shall comply with the national drug specifications. Where the drug specifications approved by the drug administrative department strict than t

53、he national drugspecification, the approved specification shall be implemented; where the national drug specification is not in place, the approved drug specification shall be complied with.The "Pharmacopoeia of the People's Republic of China" and drug specifications published by the d

54、rug administrative department are the national drug specifications.The drug administrative department of the State Council shall, jointly with the competent health administrative department of the State Council, organize the pharmacopoeia committee to take charge of formulation and revision of the n

55、ational drug specification.The drug testing institution set up or appointed by the drug administrative department of the State Council shall be responsible for calibration of national drug standard substances and references materials.Article 29 Drug names listed in the national drug specifications s

56、hall be generic drug names. Names listed as generic drug names shall not be used as a trademark.Chapter 3 Drug Marketing Authorization HolderArticle 30 Drug Marketing Authorization Holder (MAH) refers to enterprises or R&D institutions which hold a drug approval license.MAHs shall, pursuant to t

57、he provisions of this Law, be liable for non-clinical study, clinical trial, manufacturing and distribution, post-marketinging study, monitoring, reporting and handling of adverse reactions of the drug product. Other organizations and individuals engaged in drug research and development, manufacturi

58、ng, distribution, storage, transportation, use activities etc shall abide by the corresponding liability pursuant to the law.The legal representative and the principal responsible person of the MAH shall take full responsibilities for the quality of the drug products.Article 31 The MAHs shall establish a drug quality assurance system, and appoint specialized personnel to take charge independently of drug quality management.The MAHs shall conduct the audit on the quality management system of their entrusted drug manufacturing enterprise and drug