[heavyweight] after the 2018 deadline was cancelled, the official draft of the reference preparation finally came!

After the cancellation of the 2018 deadline, the official draft of the reference preparation finally came! On March 28, the State Food and Drug Administration issued the announcement on the issuance of the procedures for the selection and determination of reference preparations for chemical generic drugs (No 25, 2019), and officially announced the procedures for the selection and determination of reference preparations for chemical generic drugs The former State Food and Drug Administration issued the record on the issuance of reference preparations for the consistency evaluation of quality and efficacy of generic drugs in May 2016 The announcement of recommended procedure (No 99, 2016) shall be repealed In case of any inconsistency between the original documents of reference preparation and this announcement, this announcement shall prevail See the original announcement for details: in order to standardize the evaluation and consistency evaluation of generic drugs, optimize working procedures, strengthen service guidance, and ensure fairness, fairness and openness, the State Drug Administration has organized and formulated the procedures for selection and determination of chemical generic reference preparations, which are now published This announcement shall come into effect as of the date of promulgation The announcement on the procedure for filing and recommending reference preparations for quality and efficacy conformity evaluation of generic drugs (No 99, 2016) issued by the former State Food and Drug Administration in May 2016 shall be repealed at the same time If the relevant documents of reference preparations originally issued are inconsistent with this announcement, this announcement shall prevail On March 25, 2019, the procedures for the selection and determination of chemical generic reference preparations were formulated by the State Food and drug administration to standardize the review and consistency evaluation of generic drugs, optimize the working procedures, strengthen service guidance, and ensure fairness, fairness and openness Now, the procedures for the selection and determination of chemical generic reference preparations are specified as follows 1、 Selection principle: the selection of reference preparations should aim at providing high-quality generic drugs to the public, and the selection should be in the following order: (1) the order of selection of the original research drugs is: the original research drugs listed in China, the drugs produced in China or produced by technology transfer by foreign original research enterprises after examination and confirmation, and the original research drugs not imported The original research drug refers to the first drug approved for listing at home and abroad, and has complete and sufficient safety and effectiveness data as the basis for listing （2） In the case that the original research drug is not suitable to be used as a reference preparation due to the suspension of production or quality reasons, the internationally recognized same drug approved for listing in the United States, Japan or the European Union and the internationally recognized same drug produced in China or produced by technology transfer confirmed by audit can be selected Internationally recognized generic drugs refer to generic drugs approved to be listed in the United States, Japan or the European Union and obtained the status of reference preparation （3） Other drugs with safety, effectiveness and quality controllability are evaluated and determined by the State Drug Administration See Appendix 1 for the flow chart of reference preparation selection path and determination procedure 2、 Selection path (1) enterprises and industry associations applying for drug production and R & D enterprises or industry associations shall, in accordance with the above principles, apply to the drug review center of the State Food and Drug Administration (hereinafter referred to as the drug review center) through the application platform of reference preparation selection, and the drug review center shall reply within 60 working days Enterprises and trade associations shall submit application materials to the drug examination center in accordance with the requirements of the application form for selection of reference preparations (Appendix 2) and the catalogue of application materials for selection of reference preparations (Appendix 3) Website of reference preparation selection application platform: https://wbca.cde.org.cn/wbca/ （2） The drug audit center may recommend the reference preparation based on the drug registration data and relevant information 3、 Determine the procedure (1) the center for examination and deliberation shall examine the application materials submitted by enterprises and industry associations, form preliminary examination opinions and submit them to the Expert Committee for deliberation （2） The publicity and release center will publicize the review results to the public for 10 working days After the publicity, the results will be reported to the State Drug Administration for release The varieties with objections will be handled according to the handling method of reference preparation doubt （3） If the enterprise has any objection to the publicized or published reference preparation, it may raise objections and suggestions to the drug examination center The drug Audit Center will review and classify the demonstration materials submitted by the enterprise 1 The drug Audit Center shall give a reply within 45 working days after deliberation to the previous objections that can be resolved by the expert committee or existing laws and policies 2 For any objection other than the above, the drug examination center shall organize and convene an expert committee for deliberation according to the selection procedure, and reply within 60 working days In principle, the Expert Committee on the same question shall not demonstrate more than twice （4） In case of major technical problems in the selection and determination of reference preparations, the communication and exchange mechanism enterprise may communicate with the drug Audit Center in accordance with the relevant provisions of the administrative measures for communication and exchange of drug research and development and technical review 4、 Other requirements 1 Drug manufacturers applying for self certification as reference preparations shall guarantee the quality and accessibility of reference preparations 2 Enterprises and associations shall ensure the authenticity and integrity of application materials 3 The qualification of the reference preparation of the drug will be revoked if it is verified that there are false information provided, the supply of the reference preparation is stopped or there are quality problems Attachment: 1 Flow chart of reference preparation selection path and determination procedure 2 Application form of reference preparation selection 3 Application data catalog of reference preparation selection 1 Flow chart of reference preparation selection path and determination procedure 2 Application form of reference preparation selection No.: Note: all items in the above table need to be filled in If not, please explain the reason in the table For drug manufacturers who actively apply for the reference preparation, please fill in "not applicable" in the part of information about the product to be evaluated Appendix 3 list of application materials for reference preparation selection I overview of varieties at home and abroad 1 R & D history of varieties at home and abroad 2 Approval of varieties at home and abroad It includes the drug approved by treatment equivalence evaluation (Orange Book) issued by the food and Drug Administration of the United States, the quality information collection of medical pharmaceutical products (Orange Book) issued by Japan, the collection and reference preparations of European countries and European Union, and the domestic approval and reference preparations 3 Domestic and foreign use (including clinical use and sales) 2 The reference preparation selection basis explains the reasons for selection / application, and provides supporting evidence 3、 Self certification materials of real estate and technology transfer drugs 1 Comparison of prescriptions and packaging materials at home and abroad 2 Comparison of production processes at home and abroad 3 Comparison of quality standards at home and abroad 4 Explanation of previous production process changes after Listing 5 Explanation of impact of previous production process changes on quality after listing 6 Pre and post marketing clinical research data (including bioequivalence research data, post marketing safety data or materials) 7 Other supporting materials (such as qualification supporting materials, technology transfer supporting documents, letter of commitment to ensure continuous supply, etc.) 8 Self certification conclusion 4 Other issues to be addressed 5 Reference 6 Appendix (scanning copy of reference) (Note: 1 The enterprise only needs to submit the application on the application platform of reference preparation selection, and does not need to submit paper materials 2 fill in the second, third item according to the application of the enterprise If not involved, please fill in "not applicable".)