[heavyweight] official release! Accelerating the new policy of overseas new drug listing urgently needed in clinical practice

In order to implement the spirit of relevant meetings of the executive meeting of the State Council and accelerate the review and approval of overseas new drugs urgently needed in clinical practice, the State Drug Administration, together with the national health and Health Commission, has organized and drafted the work procedure for review and approval of overseas new drugs urgently needed in clinical practice and the requirements for application materials (see Annex), which are hereby promulgated It is hereby announced Appendix: procedure for review and approval of overseas new drugs in urgent clinical need annex Doc appendix: procedure for review and approval of overseas new drugs in urgent clinical need In order to implement the spirit of the executive meeting of the State Council on June 20, in accordance with the relevant provisions of the general office of the CPC Central Committee and the general office of the State Council, such as the opinions on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical and medical devices (Ting Zi [2017] No 42), the opinions of the food and Drug Administration on encouraging the implementation of the priority review and approval of pharmaceutical innovation (sfjhg [2017] No 126), etc, The State Drug Administration and the national health and Health Commission have established a special channel for the review and approval of overseas listed new drugs that are urgently needed in clinical practice The working procedures are as follows: 1 For new drugs listed in the United States, the European Union or Japan but not listed in China in the past ten years, the scope of the special channel for review and approval meets one of the following conditions: （1） Drugs for the treatment of rare diseases; (2) drugs for the prevention and treatment of serious life-threatening diseases without effective treatment or prevention means; (3) drugs for the prevention and treatment of serious life-threatening diseases with obvious clinical advantages 2、 The State Drug Administration and the state health and Health Commission shall, in accordance with the scope of the above varieties, organize the selection of varieties The selection work is guided by clinical value and follows the principles of openness, fairness and justice The specific procedures are as follows: (1) preliminary screening The drug review center of the State Drug Administration (hereinafter referred to as the drug review center) organizes experts to sort out the new drugs that have been listed in the United States, the European Union and Japan in the past ten years but have not been listed in China, and preliminarily select the varieties that meet the requirements of this procedure （2） Expert argumentation The State Drug Administration and the national health and Health Commission hold an expert demonstration meeting to demonstrate the list of initially selected varieties and select the list of varieties that meet the requirements of this procedure according to the expert opinions （3） Publicity The drug Audit Center shall publicize the list of selected varieties to the public, and submit written opinions and reasons to the drug audit center within 5 days in case of any objection to the publicized varieties For the dissenting varieties, a decision shall be made after another demonstration and the parties concerned shall be informed （4） Announcement The drug evaluation center of the State Drug Administration issues a list of varieties to be included in the review and approval of special channels 3、 If the review and approval procedures are included in the list of special channel review and approval varieties, and the licensees who are listed for the first time in the United States, the European Union or Japan do not have ethnic differences through research, they can carry out registration according to the following procedures: (1) communication and exchange The applicant shall apply to the drug Audit Center for class I meeting in accordance with the management measures for communication and exchange of drug R & D and technical review and approval （2） Application If consensus is formed through communication, the applicant shall prepare materials according to the requirements of application materials (see attachment) and apply according to the following circumstances: 1 For varieties that have not submitted clinical or listing application before the release of this procedure, the applicant can apply to the drug Audit Center for listing 2 For the varieties that have submitted clinical application and have not completed technical review before the issuance of this procedure, the applicant can apply to the drug review center in written form, adjust the clinical application to the listing application, and supplement all research materials obtained abroad and supporting materials without ethnic differences 3 For the varieties under clinical trial, the applicant can apply to the drug examination center for listing and continue to promote the clinical trial After the completion of the clinical trial, the applicant shall submit the research report to the drug Audit Center in the form of supplementary application 4 For the varieties that have submitted the listing application before the issuance of this procedure, the applicant may supplement all the research materials obtained overseas and the supporting materials without ethnic differences to the drug audit center 5 For the drugs that have been listed in Japan or Hong Kong, Macao and Taiwan of China and have full clinical use cases, the applicant shall provide the drug use research report of the above countries and regions, and conduct relevant analysis, and may not provide the research data of ethnic differences temporarily 6 The applicant shall submit relevant data, samples, reference materials and experimental materials for drug standard review and inspection to CFDA at the same time as required The specific requirements shall be formulated separately by CFDA （3） Review The drug Audit Center shall establish a special channel to carry out the review, and complete the technical review within 3 months after the acceptance of the drugs for treatment of rare diseases; for other overseas new drugs, complete the technical review within 6 months after the acceptance The above time limit does not include the time taken by the applicant for supplementary information If the applicant needs supplementary information during the review, the enterprise can be informed of the supplementary information at the professional review stage; the applicant can also adopt the method of rolling submission of information after communication and exchange, and supplement the information in time through the window of the applicant （4） Approval The SDA shall make a decision on examination and approval within 10 working days after receiving the examination materials submitted by the drug examination center 4、 Work requirements (1) overseas new drug applicants shall formulate risk control plan, timely report the adverse reactions, assess the risk situation, propose improvement measures, conduct continuous research on the drugs on the market, and complete relevant research work according to the approval requirements （2） For the products manufactured before obtaining the approval documents of imported drugs in China, the applicant is allowed to import and conduct inspection according to law on the premise that the production process and registration standards of the products are consistent with those approved by the State Drug Administration （3） After the approval of listing, SDA may carry out the verification of clinical trial data according to the needs of technical evaluation At the same time, strengthen the monitoring and re evaluation of adverse reactions after marketing, and take emergency control measures to stop the sale and use of drugs that have been confirmed to have serious adverse reactions Appendix: for the new drugs listed in the United States, the European Union and Japan but not yet listed in China in the past ten years, if it plans to use the overseas research data to apply for import registration according to the special channel review and approval procedures, the specific requirements of the application materials are as follows: 1 Supporting documents Provide the supporting documents approved by the drug regulatory authorities of the United States, the European Union and Japan for listing; provide the supporting documents that the drug has been listed in one of Japan, Hong Kong, Macao, Taiwan and other regions, as well as the number of drugs exported to the region in the past five years and relevant supporting documents 2 General technical documents for human drugs (CTD) require applicants to submit application materials in strict accordance with the requirements of International Conference for the technical coordination of human drugs registration (ICH) CTD format The application materials shall be basically the same as those submitted to the regulatory authorities of developed countries, and the research data accumulated after listing shall be submitted Among them, the summary part of the key research reports of M1 module, M2 module and M3 - M5 module in the CTD file should be in Chinese version and attached with the original text for reference The content of the drug instructions provided is the same as that of the instructions reviewed and issued by the original listing country, and the format is in accordance with the provisions on the administration of drug instructions and labels (Order No 24 of the State Food and Drug Administration) 3 The applicant of the racial sensitivity analysis report should refer to the relevant guidelines of ICH to conduct a consistency analysis on the efficacy and safety of Chinese and / or Asian American population and European and American population 4 Applicants for post Market Research and post market risk control plan shall make scientific judgment on whether to carry out post market clinical trials and formulate post market risk control plan, provide necessary post market research plan and specific clinical trial plan, and post market risk control plan according to the overall effectiveness and safety evaluation, as well as ethnic sensitivity analysis 5 Declaration of conformity of declaration data the applicant shall declare that the declaration data applied for import in China shall be all the data submitted to the foreign regulatory authorities at the time of application for listing, as well as the relevant research data completed after listing.