新药注册特殊审批管理办法（英文）

1、精选优质文档-倾情为你奉上(Translation by RDPAC, for its member use only)NOTIFICATION TO PUBLISH REGULATIONS OF SPECIAL EXAMINATION AND APPROVALIN NEW DRUG REGISTRATION(Guo Shi Yao Jian Zhu 200917 Hao)To all food and drug administration at provincial levels and army: In order to encourage research and developmen

2、t of new drugs and strengthen risk control, the State Food and Drug Administration (hereinafter SFDA) has developed Regulations of Special Examination and Approval in New Drug Registration in accordance with the Drug Registration regulation, which is hereby published for implementation.SFDA7th Janua

3、ry 2009REGULATIONS OF SPECIAL EXAMINATION AND APPROVAL IN NEW DRUG REGISTRATIONArticle 1: The requirements are developed in accordance with the Drug Registration Regulation for the purpose of encouraging research and development of new drugs and strengthening risk control. Article 2: In accordance w

4、ith Article 45 of Drug Registration Regulation, the SFDA may implement special examination and approval in the cases of the following applications of new drugs:1) Active ingredients extracted from plants, animals or minerals, etc. and their preparations not yet marketed in China, and newly discovere

5、d Chinese crude drugs and their preparations; 2) Chemical drug substance and their preparations and biological products not yet approved for marketing in China or abroad;3) New drugs for the treatment of diseases such as AIDS, malignant tumors and rare diseases, etc. with significant clinical advant

6、ages; and4) New drugs for the treatment of diseases, for which effective therapeutic method are not available.The new drugs for the treatment of diseases that are not covered by the state approved “Functions & Indications of TCM preparations”, may be considered as new drugs for the treatment of dise

7、ases for which effective therapeutic method is not available. For those drugs specified in items 1) & 2), the applicant of drug registration (hereinafter “the Applicant”) may apply for the special examination and approval when submitting the application for clinical trials of the new drugs. For thos

8、e drugs specified in items 3) & 4), the Applicant may apply for the special examination and approval only when submitting the production applications.Article 3: If a registration application meets the requirements specified in Article 2 by review & confirmation of SFDA in response to the application

9、 from the Applicant, SFDA shall give priority to this application in the registration procedures, then accordingly shall enhance the communication with the Applicant. Article 4: The Applicant applying for special examination and approval shall fill out Application Form for Special Examination and Ap

10、proval of New Drug Registration (Appendix 1) and submit the relevant data. The Application Form for Special Examination and Approval of New Drug Registration and the relevant data should be filed in a separate dossier and be submitted to the acceptance department for drug registration along with the

11、 application dossier required by the Drug Registration Regulation. Article 5: Upon acceptance, the acceptance department shall forward the relevant data of Special Examination and Approval application along with the submitted registration dossier to the Center of Drug Evaluation (hereinafter CDE), S

12、FDA. Article 6: CDE of SFDA is in charge of organizing a review & confirmation on the application for Special Examination and Approval, and then informs the Applicant with the review results, which will be published on the website of CDE of SFDA at the same time. 1) For those specified in items 1) &

13、 2) of Article 2, CDE of SFDA shall conduct review & confirmation within 5 days after receipt of the application for special examination and approval;2) For those specified in items 3) & 4) of Article 2, CDE of SFDA shall organize Expert Meeting for review & confirmation within 20 days after receipt

14、 of the application for special examination and approval.The time used for review & confirmation on an application for special examination and approval is included in the time frame of technical review as specified by Drug Registration Regulation.Article 7: Where a drug application is permitted ente

15、ring a special examination and approval procedure, CDE of SFDA shall conduct corresponding technical review on the application according to the relevant procedures and requirements. Authorities responsible for site inspection and lab testing should give priority to the registration application that

16、is permitted entering a special examination and approval procedure. Article 8: For the registration application permitted entering a special examination and approval procedure, in addition to data supplementation as requested by CDE of SFDA, the Applicant may also submit new data supplementation und

17、er any of the following circumstances: 1) Significant safety information newly discovered ;2) Data prepared as required by the Evaluation Meeting;3) Data needed for communication.For item 1), if the Applicant submits the supplementary data after technical review conclusion is made by CDE of SFDA, th

18、e time frame of technical review should accordingly be extended, normally 20 days. Article 9: After receiving the Deficiency Notice issued by CDE of SFDA, the applicant should complete the data supplementation within an extended 8 months if it is not possible to submit within 4 months. Article 10: F

19、or applications entering a special examination and approval procedure, CDE of SFDA shall establish a working mechanism for communication with the Applicant to jointly discuss the concerned technical issues. Article 11: For the registration application of item 1) or 2) of Article 2, provided that the

20、 same drug has not yet been granted with special examination and approval, after the basic data of pre-clinical pharmaceutical study, safety and efficacy become available, and before the clinical trial application, the Applicant may apply for communication with CDE of SFDA, where the topics may be a

21、pplication of special examination and approval, significant technical issues. Article 12: For the registration applications of Article 2, based on the completion of certain phase of clinical trials and evaluation summary, the Applicant may submit to CDE of SFDA an application for communication in re

22、spect of the following issues:1) Significant safety issues;2) Clinical trial protocol; 3) Summary and evaluation on staged results of clinical trials. Article 13: For the registration application permitted entering a special examination and approval procedure, if any significant changes are necessar

23、y during clinical trials such as protocol amendment, indication and specification change, etc., the Applicant may submit an application for communication based on the evaluation of the effects of the changes with respect to drug safety, efficacy and quality control.Article 14: To apply for communica

24、tion, the Applicant should fill out Application Form for Communication of Special Examination Approval in New Drug Registration (Appendix 2), and submit relevant data. Article 15: CDE of SFDA shall review Application Form for Communication of Special Examination and Approval of New Drug Registration

25、 and the relevant data submitted by the Applicant and notify the Applicant with the results. Article 16: When CDE of SFDA agrees to any Application for Communication, it should clearly notify the Applicant with the issues to be discussed, and confirm the Applicant with method, time, place and attend

26、ants of communication, etc., and organize the communication within 1 month after notifying the Applicant. However, for the case of Article 11, the communication should be organized within 3 monthsArticle 17: Communication should be recorded with signatures of both parties to confirm for further refe

27、rence in the subsequent study and evaluation. Article 18: The Applicant applying for special examination and approval should establish risk control and implementation plan during application for both clinical trials and production. Article 19: If any registration application granted with special exa

28、mination and approval for clinical trial application, then, while the Applicant shall still need to submit the relevant data as required by this regulation, but there will be no need for special examination confirmation as the special examination and approval shall apply automatically. Article 20: U

29、nder any of the following circumstances, SFDA may terminate the special examination and approval procedure, and publicly announce the termination on the website of CDE. 1) The Applicant asks for a termination;2) The Applicant fails to fulfill the required obligation within the specified time frame;3

30、) Expert Meeting concludes that the special examination and approval procedure is no longer appropriate.Article 21: When there is any emergency event occurs that threats the public health, as well as after occurrence of public healthcare emergency, registration of the drugs needed for such emergency

31、 shall follow the special examination and approval as specified by SFDA Special Examination and Approval Procedures of Drug. Article 22: This regulation shall go into effect as of the date of publication. Appendix 1Application Form of Special Examination and Approval in New Drug RegistrationRegistra

32、tion acceptance no. _ INN nameChemical NameRegistration Category.Indication(s)Registration application meets any of those conditionso Active ingredients extracted from plants, animals or minerals, etc. and their preparations not yet marketed in China, and newly discovered Chinese crude drugs and the

33、ir preparations; o Chemical drug substance and their preparations and biological products not yet approved for marketing in China or abroad;o New drugs for the treatment of diseases such as AIDS, malignant tumors and rare diseases, etc. with significant clinical advantages;o New drugs for the treatm

34、ent of diseases, for which effective therapeutic method are not available.Justification of the application Pages may be attached when neededRisk control and implementation planPages may be attached when neededApplicant 1 (chop) Legal representative (chop) Applicant 2 (chop) Legal representative (cho

35、p) Applicant 3 (chop) Legal representative (chop) Application date Contact person of Applicant Telephone No. Fax No. Address e-mail： Mobile PhoneNo. Notes to the Form1. This form is prepared in accordance with REGULATIONS OF SPECIAL EXAMINATION AND APPROVAL IN NEW DRUG REGISTRATION2. TCM may not nee

36、d to fill a chemical name.3. Registration Category should be identical to the Application Form of Registration Application. 4. Registration application meets any of those requirements: just to tick off “” the applicable box “”.5. Justification of the application: Any corresponding summary data to su

37、pport that the new drug registration meets any related conditions should be provided according to the specific condition in accordance with Regulations of Special Examination and Approval in New Drug Registration. The major contents in the summary data shall include the followings: (1). Summary data

38、 to support that the drugs meet the requirement of Article 2 of Regulations of Special Examination and Approval in New Drug Registration. (2). The proposed clinical trial protocol or the summary of any clinical trials that already completed. (3). Evaluation of drug safety and efficacy, while conside

39、ring the pharmacology study and toxicology study and clinical trials. (4). Summary of the pharmaceutical research that already completed. (5). Summary of other major research. The detailed research data or spectrum will not necessarily be included in this summary. Additional pages can be attached if

40、 needed but normally should be not more than 15 pages. 6. Risk control and implementation plan: Risk control plan mainly refers to precaution and prevention measures established against those potential risks during the clinical use of the new drug. Please work out specific risk control and implement

41、ation plan for clinical trial or post marketing, based on the situation and specific stages of drug development and in accordance with Regulations of Special Examination and Approval in New Drug Registration.7. This Form should be submitted within the specified time frame specified by Regulations of

42、 Special Examination and Approval in New Drug Registration. 8. This form shall be in 4 copies with 1 original and 3 duplicates. Appendix 2:Application Form to Apply for Communication of Regulations of Special Examination and Approval in New Drug Registration Registration acceptance no. _ INN nameChe

43、mical NameRegistration Category Indication(s)Registration application meets any of those requiremento Active ingredients extracted from plants, animals or minerals, etc. and their preparations not yet marketed in China, and newly discovered Chinese crude drugs and their preparations; o Chemical drug

44、 substance and their preparations and biological products not yet approved for marketing in China or abroad;o New drugs for the treatment of diseases such as AIDS, malignant tumors and rare diseases, etc. with significant clinical advantages;o New drugs for the treatment of diseases, for which effec

45、tive therapeutic method are not available.The special approval is applicable or noto Permitted o not yetSpecial examination and approval numberMethod of communicationround table video conference teleconference Study already completedBefore clinical trial application: pharmaceuticalresearch pharmacod

46、ynamicresearch toxicologyAfter clinical trial starting: Phase I Phase II Phase IIIIssues to be communicatedapplication for a special examination and approval significant technical issuessummary and evaluation on the staged results from clinical trialsclinical trial protocol significant safety issues

47、amending of the protocol change in indicationchange in specification othersIssue to be discussed and relevant dataTo attach pages if neededAttendants applying for communicationNameCompany/OrganizationTitleSpecialized FieldResponsibility during research RemarksApplicant (chop) Legal Representative (c

48、hop) Application Date Contact Person Telephone No. Fax No. Address _ e-mail： Mobile Phone No. Note to the Form1. This form is prepared in accordance with Regulations of Special Examination and Approval In New Drug Registration.2. TCM may not need a chemical name.3. Registration Category should be id

49、entical to the Application Form of Registration Application. 4. Registration application meets any of those requirements: just to tick off “” the applicable box “”.5. If the new drug registration is already permitted entering a special examination and approval, the Applicant should fill the special

50、examination and approval no.6. Method of communication: just to tick off “” the applicable box “” to indicate the desired method.7. Study already completed: please choose “Before clinical trial application” or “After clinical trials starting” to indicate the development phase of the new drug, then t

51、ick off “” the applicable box “”.8. Issues to be communicated: can be multiple choices. Please choose according to Regulations of Special Examination and Approval in New Drug Registration. Application for communication other than those in the scope will not be accepted. 9. If the application for communication is submitted before application for clinical trials, the issue(s) for communication should be explained in section of “Issue(s) to be discussed and relevant data”, with submission of medical summary and pharmaceut