What should we do if there are problems in drug evaluation? "Dispute resolution procedure of drug registration review conclusion" gives you the answer

On the evening of November 26, CDE issued a notice to solicit opinions from the dispute resolution procedure for the conclusion of drug registration review, in order to coordinate the implementation of the newly revised Measures for the administration of drug registration Article 1 [basis] of the dispute resolution procedure for the conclusion of drug registration review (Draft for comments) this procedure is formulated in accordance with the measures for the administration of drug registration (Draft for comments) in order to standardize the dispute resolution of the conclusion of drug registration technical review Article 2 [scope of application] if the applicant for drug registration (hereinafter referred to as "the applicant") has any objection to the technical review opinions made by the drug review center of the State Drug Administration (hereinafter referred to as "the drug review center") and raises a complaint, this procedure shall apply Article 3 [definition] appeal refers to the process in which the applicant appeals to the review conclusion made by the drug review center and requests to make a review conclusion again Dispute resolution refers to the process in which the drug review center organizes a comprehensive assessment and expert advisory committee argumentation for the disputed technical review conclusion after receiving the applicant's appeal opinion, so as to form the final technical review conclusion The appeal shall put forward and explain the reasons for the dissenting matters in the conclusion of technical review, the contents of which are only limited to the original application matters and the original application materials, and shall not include new test data or re analysis and sorting of the original data Article 4 [communication] dispute resolution is an important part of the review process During the review process, the drug review center shall strengthen communication and exchange with the applicant to effectively resolve the technical issues in dispute Article 5 [principles] the dispute settlement work shall follow the principles of law, science, justice, openness and fairness Article 6 [inform] after the completion of the technical review, the drug review center shall inform the applicant through the website of the drug review center of the conclusion of the technical review not passed and the right, channel, method, matter and time limit for the applicant to file a complaint, and at the same time notify the applicant by email Article 7 [appeal] if the applicant holds an objection, he shall, within 15 working days from the date of receiving the notice, file an appeal through the website of the drug review center, and the appeal shall state the reason and basis Article 8 [comprehensive evaluation] after receiving the appeal opinions of the applicant, the drug examination center shall conduct a comprehensive evaluation through the technical committee of the Department Article 9 [adjustment Conclusion] after comprehensive evaluation, if the drug review center believes that the technical review report and conclusion need to be adjusted, it shall make adjustment in time Article 10 [maintain original conclusion] after comprehensive evaluation, the drug Audit Center shall still make a review conclusion of maintaining disapproval for those who do not meet the requirements of current laws and regulations or obviously fail to meet the basic requirements of registration technology, and actively communicate with the applicant in accordance with the requirements of administrative measures for communication and exchange of drug research and development and technical review In case of such circumstances, the applicant's application for holding an expert advisory committee for demonstration is generally not accepted Article 11 [application for demonstration by the Expert Consultation Committee] in case that the review considers that the existing data are insufficient to support the application items, the current technical standard system issued is not covered, and there are technical disputes between the applicant and the review parties, the applicant has the right to apply for holding the demonstration by the expert consultation committee after the drug review center feeds back the applicant Article 12 [convening expert advisory committee argumentation] the drug examination center shall organize and convene within 50 working days from the date of receiving the application for convening expert advisory committee argumentation from the applicant, and form the final review conclusion based on the argumentation results of the expert advisory committee The procedures demonstrated by the expert advisory committee shall be implemented in accordance with the provisions of the measures for the administration of the Expert Advisory Committee for drug registration and evaluation (for Trial Implementation) Article 13 [central processing] if it is still difficult for the drug review center to make the final review conclusion in the process of the comprehensive expert advisory committee's argumentation, it may submit it to the technical committee of the center for resolution to form the final review conclusion Article 14 in the process of organizing the expert advisory committee's argumentation, if the applicant fails to submit the meeting materials on time, does not attend the meeting without any reason and withdraws the application, the final evaluation conclusion shall be formed according to the comprehensive evaluation results Article 15 [time calculation] the time of the applicant's appeal and the expert's public demonstration meeting organized by the drug examination center shall not be included in the review time limit Article 16 [interpretation] this procedure shall be interpreted by the drug audit center Article 17 [implementation time] this procedure shall be implemented from the date of promulgation Drafting instructions for dispute resolution procedure of drug registration review conclusion (Draft for comments) In order to cooperate with the implementation of the newly revised Measures for the administration of drug registration (hereinafter referred to as the measures), and in accordance with the overall arrangement of the State Administration for the preparation and revision of the measures, our center has organized the drafting of the consultation draft of the dispute resolution procedures for the conclusion of drug registration review (hereinafter referred to as the procedures), and the relevant information is described as follows 1、 The drafting background is to properly resolve the dispute between the drug examination center and the applicant The newly revised measures add the appeal link of technical content dispute before the end of examination and approval If the review conclusion is not passed, the technical dispute shall be resolved through appeal, comprehensive evaluation and expert advisory committee demonstration According to the newly revised measures, our center has conducted internal research and discussion for many times to form the procedure 2、 The main content of this procedure is 17 articles in total, which mainly stipulates the dispute resolution procedure of the applicant's objection after the conclusion of the drug review is not passed, including informing the applicant of the conclusion of the review, the applicant's appeal, the comprehensive assessment, the feedback of the results of the comprehensive assessment, the demonstration of the expert advisory committee, etc At the same time, this procedure clearly defines the scope of application, relevant definitions, processing principles, time limit and other issues 3、 Matters to be explained 1 The relationship between the current review and the dispute resolution of the review conclusion According to the newly revised measures, the settlement of technical disputes will be advanced to the stage of drug technical review, replacing the current review procedure in which the applicant has objections to the decision of disapproval made by the State Administration, and the review application will not be accepted subsequently 2 Matters not covered in this procedure shall be implemented in accordance with relevant national laws and regulations and relevant provisions of the State Administration, especially the procedures demonstrated by the expert advisory committee, and in accordance with the administrative measures for the Expert Advisory Committee for drug registration and review (Trial) (2017 No 27) issued by the State Administration 3 This procedure regulates the dispute resolution of review conclusions, which inevitably leads to omissions All sectors of the society are requested to put forward opinions and suggestions on relevant operation details Our center will further modify and improve them according to your opinions and suggestions 37