The Code for the Management of Supplementary Information (Draft for Comments) of the Drug Review Center was published.

in line with the implementation of the new revision of the Measures for the Administration of Drug Registration, our center organized the draftofed "Drug Review Center Supplementary Information Management Code (draft for comments)," now the center's website to be published, to widely listen to the views and suggestions of all walks of life, welcome all walks of life to put forward valuable comments and suggestions, and please timely feedback to usComments: 1 July 2020 to 10 July 2020your feedback to the following email: shamq@cde.org.cn
thank you for your participation and supportthe Drug Review Center of the State Drug Administrationarticle 1 of theof July 1, 2020, "Based on" to regulate the management of supplementary information for drug registration review, to clarify the basis and requirements for supplementary information, and to improve the quality and efficiency of the applicant's supplementary informationThis Code is formulated in accordance with the provisions of Article 87 of the Measures for the Administration of Drug RegistrationArticle 2 "Scope of Application" The Drug Review Center of the State Drug Administration (hereinafter referred to as the Drug Review Center) shall, in accordance with the needs of the review, notify the applicant for drug registration (hereinafter referred to as the applicant) to add new technical information on the basis of the original declaration information, or only need the applicant to explain, the Present Code shall applyArticle 3 "Inquiry Definition" The inquiry in this Code refers to the process by which the Drug Review Center, in the course of the review process, has doubts or believes that there is a problem with the original declared or supplementary information, takes the initiative to communicate with the applicant, and requests the applicant to explain or provide relevant supporting materialsArticle 4 "Principles of Work" The principles of law, science, fairness and fairness shall be followed in the process of supplementing informationArticle 5 "Definition of Professional Review Inquiries" During the professional review or the comprehensive review period, if the professional presiding review on the basis of full review doubts or believes that there is a problem with the reporting information, after examination by the head of the review department, the applicant is sent a "professional review inquiry letter" through the drug review center website to inform the applicant of the specific content, basis and requirements of the problem, and request a written reply within 5 working days"Professional review inquiry letter" is not a formal written supplementary information notification, does not represent the final review decision-making opinion, the review timing is not suspendedArticle 6 "Professional Review Inquiry Standards" The Pharmaceutical Review Centre informs the applicant of the following information through the "Professional Review Inquiry Letter":1) supporting materials that can be provided without the need for research;2) no need to supplement new technical information, only explanation of the original declaration materials, and3) the review of defects that may be required to be refinedArticle 7 "Professional Inquiry Response" The applicant shall, within 5 working days of the "Professional Review Inquiry Letter", provide an explanation or a written replyFor those who need a written response, the download and print of the "Professional Review Inquiry Letter" through the DRUG Review Centre website as the basis for receiving supplementary information to be incorporated into the file may also be submitted to the centre for review reference by the electronic version of the supplementary informationArticle 8 "Written Request" In the course of the review process, the applicant needs to add new technical information on the basis of the original declaration information, combined with the "professional review inquiry letter" response, the Drug Review Center in principle put forward a supplementary information request, after setting out all the problems, in writing to inform the applicant within 80 working days to supplement the submission informationArticle 9 (Supplementary Information) The applicant shall submit all supplementary information at one time, as required, within 80 working days, and the time of the supplementary information shall not be included in the time limit for drug reviewArticle 10 "Start-up review" The drug review center shall initiate the review after receiving all the additional information from the applicant, and extend the time limit for the review by one third;Article 11 "Supplementary consultation" The applicant has questions about the request for supplementary information in writing, may submit a general technical consultation application through the website of the Pharmaceutical Review Center within 10 working days through the website of the Drug Review Center, and the project manager coordinates the adaptation team to complete the reply in writing or by meeting within 15 working days, and if the meeting is required, in principle, in the form of a conference callArticle 12 If the applicant still has any objection to the reply to the reply to the supplementary information consultation, he may, within 10 working days from the date of receipt of the reply, make an objection through the website of the Drug Review Center, and the objection shall state the reasons and basisArticle 13 "Objection Handling" After receiving the applicant's objection, the Drug Review Center shall organize the relevant professional and technical committee meeting to conduct a comprehensive assessment within 15 working daysArticle 14 "Adjusting the requirements for distribution" The Drug Review Center, after comprehensive assessment, believes that it is necessary to adjust the requirements for the issuance of supplements, shall re-conduct the technical review within 3 working days and inform the applicant of the results of the adjustment through the drug review center websiteArticle 15 "Maintaining the original replacement requirements" The drug review center, after comprehensive assessment, does not need to adjust the requirements for the distribution of supplements, within 3 working days through the drug review center website to inform the applicant not to agree to the issue of objections reasons and basisArticle 16 (Inquiries and recommendations for withdrawal) After receiving all the additional information, the review department has doubts about the supplementary information or believes that there is a problem with the content, and will not, in principle, make the supplementThe professional presiding judge drafts a "supplementary information inquiry letter" on the reasons and grounds for not meeting the requirements of the notification requirements or not fully responding to the contents of the supplementary notice, and if new technical information is still required, the applicant is advised to withdraw the application on its own initiative and explain the reasonsAfter examination by the head of the review department, the applicant is informed by a "supplementary information inquiry letter" issued through the website of the Drug Review Center that the time limit for the review shall not be suspendedArticle 17 "No Approval Conclusions Publicity" The applicant shall explain or voluntarily withdraw the application within 5 working days of the "Supplementary Information Inquiry Letter" for the explanation of the additional informationIf the applicant does not reply to the "additional information inquiry letter" or does not agree to withdraw the trial, the Drug Review Centre will make a non-approval review conclusion and make public on the basis of the information available, as appropriateThe applicant may raise objections in accordance with the Procedure for The Resolution of Objections to the Conclusions of the Drug Registration Review Article 18 "Re-issuance situation" For innovative drugs and new safety indicators not specified in the guiding principles, etc., may be re-compensated in accordance with the needs of the review and communication with the applicant Article 19 "Expiration Reminder" The Drug Review Center website will add the time limit expiration reminder function of supplementary information, and issue a time limit expiration reminder on the 5th working day before the expiration of the time limit for the notification of supplementary information requirements, reminding the applicant to supplement the information on time Article 20 "Termination of review" If the applicant fails to submit additional information within the prescribed time limit, the Operational Management Office of the Drug Review Center will proceed with the termination of the review procedure in accordance with the conclusion of the non-approval Article 21 of the " Data Reception: The Operational Management Department of the Drug Review Center shall, in accordance with the requirements for distribution and the standards for receiving information, review the integrity of the supplementary information and will not receive information that exceeds the requirements for the request and the request for inquiry letters Article 22 "Re-declaration" Applicants who need to re-submit a registration application after termination of the review shall communicate with the Drug Review Centre in advance and explain the improvement of the information and the conclusions of the previous review in the declaration information Article 23 This Code shall come into effect as of the date of its issuance The paper supplement standard (trial) for drug review (trial) for the standardization and necessity of unified supplementary requirements, strictcontrol of the number of times in the process of review, in accordance with the relevant provisions of the Measures for the Administration of Drug Registration and the actual work of the drug technical review, the drug review center after research and discussion, the current evaluation of the standards for the issuance of the review is as follows: 1 According to the relevant requirements of the declaration information, the declaration information is inconsistent or inconsistent, unclear, irregular, Research design, testing process and data analysis, such as defects or incomplete, 3 Research design and data analysis, such as there are differences or doubts with the current scientific knowledge and consensus, 4 Quality standards, specifications, manufacturing and verification procedures, production process information sheets and other key content of the writing involves major changes; 5 Supplementary analysis of important safety and effectiveness results; 6 7 Major issues of risk control plans ; 8 If the basis of the variety problem is insufficient and further information is required, such as the clinical positioning is not clear, 9 If the API, accessories and package materials are not required to be supplemented by the announcement on the evaluation and approval of the examination and approval of the api, pharmaceutical accessories and pharmaceutical packagematerials (No 146 of 2017) and related requirements, if the original package information is not registered as required by the announcement or not submitted at the same time in the application for pharmaceutical preparation, no authorization is provided The route of administration of the original auxiliary package does not meet the method of administration of the preparation, etc.; 10 It is necessary to carry out sample inspection, on-site inspection, equipment association review but not carried out, or production inspection, on-site inspection, equipment association review found that the problem requires additional information; 11 The major safety accident of the product during the review process or the review of the product found a major safety risk; 12 there is a report of the need for additional information; Or the problems found in the original supplement package need to be resolved through the preparation review; 14 After communication with the applicant, the review considers that there is a real need for replacement and has not been stipulated in the open supplement criteria, after study by the department technical committee, submitted to the director of the central branch for approval, and updated the center's supplementary standards after the external release of the enforceable In order to implement the relevant provisions of the Measures for the Administration of Drug Registration (hereinafter referred to as the New Edition of the Registration Measures) and further standardize the written supplement, the Drug Review Center has organized the drafting of the Code for the Management of Supplementary Information of the Drug Review Center (hereinafter referred to as the "Regulations"), which is explained as follows: according to the new edition of the Registration Article 87 of the Measures "If the applicant needs to add new technical information on the basis of the original declaration information after acceptance, the Drug Review Center shall, in principle, submit a request for additional information, specify all the problems, and notify the applicant in writing to submit the information within 80 days." ..."The Drug Review Center has carried out written research work, and after many internal studies and discussions, this Code has been formed (i) standardize the replacement process and reduce the number of replacements Around article 87 of the new Registration Measures, "The Drug Review Center puts forward a supplementary information request in principle", the standard international advanced work experience, in the form of "inquiry letter" to increase the effective communication channels before and after the replacement, the review period of doubt and problems to reach consensus, in order to reduce unnecessary replacement (ii) embodies the principle of "letting go" and encouraging innovation Taking into account the current industry's opinions and suggestions on the written supplement work, in-depth implementation of the drug regulatory "management" reform work, with information construction as a guarantee, set up the deadline reminder of the time limit for the payment; a total of 23 articles in 6 chapters of the Code First, the scope of application, definition and basic working principles of supplementary data management norms are clarified Second, the introduction of professional review inquiry letter and supplementary information inquiry letter, increased the drug review center to take the initiative to reach consensus with the applicant on additional information, is conducive to the applicant to understand the problems in the review process Third, the addition of supplementary information during the supplementary consultation and the processing of supplementary objections, improve the drug review center and the applicant's communication efficiency, is conducive to the applicant better understand the requirements of the supplement and one-time according to the requirements to submit all supplementary information Fourth, increase the expiration of the replacement time reminder and terminate the review process, the replacement process to improve and refine.