Drug registration management methods to improve the review results of the controversial treatment.

In the Measures for the Administration of Drug Registration, which was officially implemented on 1 July this year, eight cases of non-approval were identified, and provisions were also made for the review of disputes.
Article 90 of Chapter VI stipulates that during the period of drug registration, if the conclusion of the review is not passed, the Drug Review Center shall inform the applicant of the reasons for its refusal, and the applicant may raise an objection with the Drug Review Center within 15 days.
drug review center in conjunction with the applicant's objections to conduct a comprehensive assessment and feedback to the applicant.
if the applicant still has any objection to the results of the comprehensive assessment, the Drug Audit Center shall, in accordance with the provisions, organize the expert advisory committee to demonstrate within 50 days and form a final review conclusion based on the results of the experts' argumentation.
the introduction of this settlement procedure is a detailed complement to the above-mentioned provisions.
procedure for resolving objections to the conclusions of drug registration reviews (trial) Article 1 This procedure shall be formulated in accordance with Article 90 of the Measures for the Administration of Drug Registration in order to regulate the handling of objections to the conclusions of drug registration reviews. article
If the applicant for drug registration (hereinafter referred to as the applicant) disputes the conclusion of the review made by the Drug Review Center of the State Drug Administration (hereinafter referred to as the Drug Review Center), the procedure shall be applied if the pharmaceutical examination center organizes an objection.
Article 3 Objection resolution refers to the process of completing a comprehensive review and the conclusion of the review is not adopted, after the Drug Review Center has informed the applicant, the applicant raises an objection, and the Drug Review Center organizes a comprehensive assessment or expert advisory committee to demonstrate the final technical review conclusions.
the applicant shall raise and explain the reasons for the objections in the conclusions of the review, the contents of which shall be limited to the original application and the original declaration materials.
Article 4 Objection resolution is an important part of the review process, and the Drug Audit Center should strengthen communication and communication with the applicant in the review process to effectively resolve the objection problem.
Article 5 The resolution of objections shall be guided by the principles of law, science, fairness and impartiality.
article 6 The Drug Review Center shall, within 5 days after the completion of the comprehensive technical review, inform the applicant through the website of the Drug Review Center of the conclusions, reasons and the applicant's right to object, channels, methods, matters and time limits.
Article 7 The applicant may raise an objection through the website of the Drug Audit Center within 15 days from the date of receipt of the notice, and the objection shall set out the reasons and basis.
the drug examination center receives the applicant's dissenting opinion, it shall organize a comprehensive assessment within 15 days in the light of the dissenting opinion.
if the Drug Audit Center, after a comprehensive assessment, considers that it is necessary to adjust the conclusions of the review, it shall re-evaluate the technical review within 20 days and inform the applicant of the results of the adjustment through the website of the Drug Review Center.
article 10 If the Drug Audit Center, after a comprehensive assessment, considers that it does not meet the basic requirements of the existing laws and regulations, or clearly does not meet the basic requirements of registration technology, or has convened an expert advisory committee during the review process and the conclusions of the review are based on the conclusions of the expert advisory committee, and the conclusions of the original review are maintained, the applicant shall be actively communicated and exchanged within 5 days.
this situation will no longer be demonstrated by an expert advisory committee.
Article 11 After a comprehensive assessment, the Drug Audit Center shall, after a comprehensive assessment, consider that the existing research data or research data are insufficient to support the declaration, that the existing technical standard system issued does not cover the situation, and that there is a technical dispute between the applicant and the reviewer, etc., the results of the comprehensive assessment shall be fed back to the applicant within 5 days.
if the applicant still has any objection to the results of the comprehensive assessment, he may submit an application for an expert advisory committee within 15 days after receiving the feedback through the website of the Pharmaceutical Review Center, and submit the relevant information of the meeting together.
12 The Drug Review Center shall organize the convening of the examination center within 50 days from the date of receipt of the applicant's application for an expert advisory committee to demonstrate, and shall form a final review conclusion based on the results of the expert demonstration.
, as demonstrated by the Advisory Committee of Experts, is carried out in accordance with the relevant provisions.
Article 13 In the course of organizing the argumentation of the expert advisory committee, if the applicant does not submit the meeting materials on time, does not attend the meeting according to the agreed time, and withdraws the application for the expert advisory committee's argumentation, the Drug Audit Center shall form a review conclusion based on the submitted information.
14 The time limit stipulated in these procedures shall be calculated on a working day.
the applicant, the drug review center to resolve the objection and the time for expert argumentation shall not be included in the time limit for the review.
after the approval of the application for drug registration, the applicant may file an administrative reconsideration or administrative action in accordance with the law if he has any objection to the decision on administrative license.
Article 16 These procedures shall come into effect as of the date of publication.
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