The National Medical Products Administration recently issued the "Pilot Work Plan for Optimizing the Review and Approval of Innovative Drug Clinical Trials", proposing to optimize the review and approval mechanism for innovative drug clinical trials, strengthen the main responsibility of drug clinical trial applicants (hereinafter referred to as "applicants"), enhance the risk identification and management capabilities of drug clinical trial stakeholders for innovative drug clinical trials, and achieve the completion of the review and approval of innovative drug clinical trial applications within 30 working days, shortening the start-up time of drug clinical trials. The pilot work will last for one year. During the pilot period, at least 10 varieties of clinical trial applications will be reviewed and approved within the pilot area, and clinical trials will be initiated. The work plan is clear, and pilot projects will be carried out in provinces that meet the conditions. The scope of the pilot project is to apply for clinical trials of Class 1 innovative drugs (excluding cell and gene therapy products, vaccine products, etc.). Applicants are not subject to regional restrictions and must have been approved for at least 3 innovative drug clinical trial applications both domestically and internationally, with rich experience in clinical trial implementation and drug surveillance management. The pilot institutions are generally national medical centers or national clinical research centers within the pilot area, and have established a work system to provide clinical trial project initiation, ethical review, and contract review services before the applicant submits a new drug clinical trial application. (New Society)
Edit：He Chuanning Responsible editor：Su Suiyue
Source：People's Daily
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