The General Office of the National Medical Products Administration is seeking public opinions on the "Notice on Optimizing the Evaluation and Approval of Clinical Trials for Innovative Drugs".
In order to implement the requirements of the "Opinions of the General Office of the State Council on Comprehensive Deepening of Drug and Medical Device Regulation Reform to Promote High-Quality Development of the Pharmaceutical Industry," and to support the research and development of innovative drugs, the National Medical Products Administration has drafted the "Announcement on Relevant Matters of Optimizing the Evaluation and Approval of Clinical Trials for Innovative Drugs" based on the experience of conducting pilot projects to optimize the evaluation and approval of innovative drug clinical trials. The announcement is now open for public comments.
It is mentioned in the announcement that in order to further support the research and development of innovative drugs guided by clinical value and improve the quality and effectiveness of clinical research and development, the evaluation and approval of clinical trial applications for eligible innovative drugs should be completed within 30 working days. The 30-day channel for the evaluation and approval of clinical trial applications supports national key research and development varieties, encourages global early synchronized research and international multicenter clinical trials, and serves clinical needs and the development of the national pharmaceutical industry.
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