英文译稿《药品注册管理办法》

1、药品注册管理办法英文版Provisions of Drug Registration（The measure of Drug Registration is approved by State Administration for Market Regulation in Order No.27 on January 22，2020）Chapter 1：General PrinciplesArticle 1：For the purposes of standardizing drug regulation behaviors and ensuring the safety，effectiven

2、ess and quality control of the drugs, the provisions is enacted according to The Drug Administration Law of Peoples Republic of China（hereinafter called“ The Drug Administration”），Law of the peoples Republic of China on Traditional Chinese Medicine，Vaccine Administration Law of the Peoples Republic

3、of China（hereinafter called “Vaccine Administration Law”），Law of the Peoples Republic of China on Administrative Permission，Regulations for Implementation of the Drug Administrationand other laws and administrative regulations.Article 2: The provisions is applicable to the activities of drug researc

4、h，registration and supervision and administration for the purposes of launching the drug within the territory of the Peoples Republic of China.Article 3: Drug Registration refers to the applicants of Drug Registration（hereinafter called “Applicant”）submitting the files of drug clinical trials，drug m

5、arketing authorization，re-registration and supplementary applications according to the legal procedures and related requirements. The administration decides whether to approve such the application according to review the safety, effectiveness and quality control based on laws and regulations and exi

6、sting scientific cognition.The applicant is Marketing Authorization Holder（hereinafter called “MAH”）after achieving the marketed drug license.Article 4：Drug registration is divided into Traditional Chinese Medicine，Chemical Medicine and Biological products for classified managementTraditional Chines

7、e medicine registration is classified according to innovative traditional Chinese medicine, Modified traditional Chinese Medicine, compound preions of traditional Chinese medicine of ancient classical preion, same preion of same name。Chemical drug registration is classified according to innovative c

8、hemical drugs，modified chemical drugs and generic drugsThe registration of Biological products is classified according to innovative biological products, modified biological products and marketed biological products（including Biosimilars）Detailed classification and corresponding requirements of appl

9、ication files of Traditional Medicine，chemical drug and biological products will be organized and drafted and then be announced to public based on product features，degree of innovation，review management of the drug by National Medical Products Administration（NMPA）The application of the drugs manufac

10、tured overseas should be executed according to the detailed classification and corresponding requirements of the application filesArticle 5：National Medical Products Administration is in charge of national drug registration, responsible for establishing system and institution of drug registration, d

11、rafting standard of drug registration management, organizing the activities of evaluation and approval of drug registration and relevant supervision and administration in accordance of law. Center for Drug Evaluation (herein after called CDE), NMPA is responsible for evaluating the applications of d

12、rug clinical trials，drug marketing authorization, supplementary applications and re-registration of drugs manufactured overseas. National Institutes for Food and Drug Control(hereinafter called NIFDC),Chinese Pharmacopoeia Commission(hereinafter called CPC),Center for Food and Drug Inspection of NMP

13、A(hereinafter called CFDI), Center for Drug Reevaluation, NMPA(hereinafter called CDR), Center for Administrative Affairs Acceptance and Complaint Reports, NMPA(hereinafter called NMPAAACR), Center for Information, NMPA(hereinafter called NMPAIC) and other professional and technical institutions are

14、 in charge of promoting the implementation of drug quality control, approval of common name, inspection, monitoring and evaluation, system permit and certification, corresponding information construction and management, etc.Article 6: Regulatory authorities of each province, autonomous region and pr

15、ovince-level municipality are in charge of the following relevant activities of drug registration within respective administrative regions, including:(1) Accept，review and approve the re-registration of the domestic drugs.(2) Manage filings of modifications and reporting matters of post-marketing dr

16、ugs(3) Organize the daily surveillance and investigating and handing illegal acts of non-clinical drug safety evaluation research institute and clinical trial institution.(4) Participate in the verification and inspection organized by NMPA(5) Relevant affairs of drug registration entrusted by NMPADr

17、ug administration of each province, autonomous region and province-level municipality is responsible for the implementation of review，inspection，verification，monitoring and evaluation through the management of drug supervision with internally established institution or appointed drug professional an

18、d technical institution.Article 7: Drug registration should comply with the principle of openness, fairness and equity. Take the clinical value as guide, encourage research and develop new drugs and actively promote the development of generic drug.NMPA keeps expanding trials of comprehensive reforms

19、 in evaluation and approval system, optimize the procedures of evaluation and approval, raise the efficacy of evaluation and approval, take the evaluation as leading factor, provide inspection, verification, monitoring and evaluation as support for building the system.Charpter2: Basic system and req

20、uirementsArticle 8: Engaging in drug research and drug registration should comply with laws, regulations, rules, regulatory documents, standards and specifications. Consulting relevant technical guidelines and using other evaluation method and techniques should be proved to be scientific and applica

21、ble. The information through the whole process should be guaranteed to be true, accurate, complete and traceable.Drug should comply with the national drug standards and the drug quality standards authorized by NMPA. The drug quality standards approved by NMPA are called durg registration standards.

22、Drug registration standards should fit in with general technical requirements in Pharmacopoeia of the Peoples Republic of China which should not be less than the provision of the Pharmacopoeia. The applicant should provide sufficient supportive data when the inspection items or testing (detection) i

23、ndex do not apply to the Pharmacopoeia.CDE and other professional technique institutions should develop the principle of technical guidance and procedure on the basis of scientific development, industry development reality and requirements in drug supervision (administration).Article 9: The applican

24、t should be the enterprises to bear legal liability (responsibility) or the drug research institution. Foreign enterprise should appoint domestic business corporation to handle the drug registration items.Article10: The applicant should finish the pharmaceutical research，pharmacology and toxicology

25、study，drug clinical trials，etc. Applicant should carry out the non-clinical safety evaluation in the institutions achieved certificate of Good Laboratory Practice (GLP) and comply with GLP. Drug clinical trials should be approved, among them bioequivalence test should set up a file. Applicant should

26、 carry out the drug clinical trials in the clinical trial institution in accordance with relevant regulation and comply with Good Clinical Practice (GCP).True, sufficient and reliable data, materials and samples should be provided when applying drug registration for proving the safety, effectiveness

27、 and quality-control of the drug.Article11: When using outside research materials and data for supporting drug registration, the source, research institution or laboratory conditions, quality requirements and other management should be in line with generally accepted practices asked by International

28、 Conference on harmonization and meet the requirements by national drug registration When changing items or other contents in the former drug approval certificates and their attachments, applicant should carry out full（sufficient，plenitude） research and verification of the change，and then make a ful

29、l assessment on the effects on safety，effectiveness and quality-control of the drug, whats more， making supplementary application，record filings or report in line with variation procedure.Article 12: Drug registration certificate is valid for 5 years，MAH should keep guaranteeing the safety，effective

30、ness and quality-control of the drug within their terms of validity and apply re-registration 6 months ago before the term of validity.Article 13：NMPA establishes systems for accelerating the marketing registration to support clinical-value-oriented drug innovation. Applicant can apply for Breakthro

31、ugh Therapy，Conditional Ratification（Approval），Priority Review and Special Examination and Approval of drugs which meets the requirement for drug registration. Through the research and registration, regulatory authorities and their professional and technical institutions should give essential techni

32、cal guidance，communication，priority resources，shorter review span（time） and other policy and technique support.Article 14: NMPA establishes Associated Evaluation and Approval System of Chemical APIs, excipients, packaging materials and containers which come into direct contact with drugs. When revie

33、wing the pharmaceutical preparations，the chemical APIs should be reviewed at the same time along with associated excipients，packaging materials and containers which come into direct contact with drugs. CED establishes information registration platform of chemical APIs, excipients, packaging material

34、s and containers which come into direct contact with drugs. The associated registration should be made public for applicant and MAH，and associated review and approval will be carried out in the registration of the pharmaceutical registration.Article 15: Carry out classification registration and tran

35、sformational management for Preion Drug and Non-preion (Over-the-counter，OTC) drug. CDE will establish the corresponding principle of technical guidance and procedure for marketing registration of OTC drugs according to the OTC drug characteristics and the make public. Drug evaluation center establi

36、shes corresponding technique requirements and procedure on transformation of preion drug and OTC drugs and make public.Article 16：The applicant can communicate with CDE and other professional technical institute on important issues at any time，such as before applying for the clinical trials，during t

37、he clinical trials and before applying for the drug marketing authorization. CDE and other professional technical institutes can communicate with the applicant as what work demands.CDE and other professional technical institutes ，according to their duties，establish the procedure，requirement and sche

38、dule of the communication respectively.Article 17: CDE and other professional technical institutes introduce expert consulting system and establish expert advisory committee as what work demands. Giving full play to the role of technology supporting specialists, refer to expert advice on important i

39、ssues during the process of review，verification，inspection and approval of common name.Article 18: NMPA establish the catalogue of chemical medicines recording newly approved drugs and generic drugs which have passed quality and effectiveness consistency evaluation. The catalogue record the drug nam

40、e, API, dosage form, specifications, whether reference preion or not, MAH and so forth, timely updated and made public. The CDE establishes the procedure and requirement of catalogue of chemical medicines and make publicArticle19: NMPA supports the preservation and innovative development of traditio

41、nal Chinese medicine（herein after called TCM），establish and improve the registration system and technique evaluation system combined with TCM, and encourage the use of modern scientific technology and traditional methods to research and develop TCM. Strengthen the quality control of TCM and improve

42、the clinical trials of TCM.Applicant should evaluate clinical value and resource when applying for registration of TCM, steering for clinical value and promote sustainable utilization of resources.Chapter 3：Drug registration for approvalSection 1: Drug clinical trialsArticle 20：The clinical trials m

43、entioned in this law mean that the drug research is aimed to ascertain the safety and effectiveness in human body for the purpose of marketing registration.Article 21：Clinical trials are divided into Phase I，Phase II，Phase III and Phase IV and bioequivalence trials. Research contents include pharmac

44、ological research, exploratory clinical trial, confirmatory clinical trial, post-marketing clinical study according to characteristics of the drug and purpose of the research.Article 22: The clinical trials should be conducted in the clinical trial institutes satisfying corresponding conditions and

45、recorded according to regulations. Among them, Vaccine clinical trials should be conducted or organized in the third-class hospital meeting the conditions set by NMPA and National Health Commission or institute at or provincial level for Disease control and prevention.Article 23：Applicant should sub

46、mit relevant research materials according to the requirements of application dossiers for the application of clinical trials after finishing the pharmaceutical and pharmacological research which support the clinical trials. The application dossiers according with the requirements will be accepted af

47、ter the verification of the forms. CDE should organize pharmaceutical，medical and other talents to review accepted clinical trial application, deciding whether they agree with the application of clinical trial within 60 days from the acceptance of the application and confirm with the applicant of th

48、e results of review in website of CDE. Failure to confirm shall be deemed to be an approval and the applicant can conduct clinical trials according to submitted proposal. The applicants who obtain permission to conduct clinical trials are called sponsor of the drug clinical trials (hereinafter calle

49、d Sponsor).Article 24: Applicant who is planning to conduct bioequivalence test should put on record(file) of bioequivalence in the website of CDE and conduct relevant research according to the file.Article 25: To conduct drug clinical trials should be examined and approved by the Ethic Committee.Th

50、e drugs used in the drug clinical trial should comply with the Criterions for the Quality Control of Clinical Trial of drugs.Article 26: When approved of conducting drug clinical trials and before starting staged clinical trials，corresponding plan for drug clinical trials should be drawn up and cond

51、ucted after approval of the Ethic Committee，in addition applicant should file relevant plan of clinical trials and supportive data in the website of CDE.Article 27：The drugs which get the approval of conducting clinical trials are planning to develop new indication( or functions) and combinations wi

52、th other drugs，the applicant should submit new application of drug clinical trials and conduct the new clinical trials after the approval.The clinical trials need to be conducted when planning to develop new indications of the marketed drugs, and also the application of new clinical trial should be

53、submitted.Article 28: The sponsor should submit the regular safety updated report during the research on the website of CDE. The safety report should be submitted once a year during the research or within 2 months for every extra year after getting the clinical approval. CDE can ask sponsor to adjus

54、t reporting period.Sponsor should report suspicious and unexpected serious adverse effects and other potential serous safety risk information to CDE according to the requirements in time. Based on the severity of safety risk, CDE can ask sponsors to adjust clinical trial, informed consent and invest

55、igators brochure，etc. ,to strengthen the measures to control the risk. Whats more，CDE can ask sponsors to suspend or terminate the drug clinical trial.CDE is responsible for the the formulation and publication of detail requirement of the safety updated report during the research.Article 29: Sponsor

56、s should evaluate the effects on the safety of subject according to the regulations and referring to corresponding technical guidelines when the change of clinical trial plan happen, non-clinical or pharmaceutical changes happen or other new findings appear.Sponsor can implement the clinical trial d

57、irectly and mention in the safety updated report during the research. The sponsors should submit supplementary application if the risk of safety increases. CDE should decide whether they agree with the supplementary application within 60 days from the acceptance of application and inform the applica

58、nt on the website of CDE. Failure to confirm should be deemed to an approval.The modified sponsor will bear the obligations and responsibilities of drug clinical trials if the change of sponsors happen.Article 30：Sponsor should adjust clinical trial plan，suspend or terminate clinical trials and repo

59、rt to CDE when finding the safety probems or other risks during the clinical trial.The sponsors should be asked to adjust clinical trial, suspend or terminate clinical trials under any of the following circumstances:(1) Ethic committee does not perform their duties.(2) The safety of the subjects cant be guaranteed.(3) The sponsors do not submit the safety updated report during the research.(4) The sponsors do not deal with and report the su