June 19, 2025
Source: drugdu
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On June 16, the State Food and Drug Administration optimized the innovative drugsThe draft for comments on clinical trial review and approval was released. It mentioned that in order to further support the research and development of innovative drugs oriented to clinical value and improve the quality and efficiency of clinical research and development, the review and approval of innovative drug clinical trial applications that meet the requirements will be completed within 30 working days. The 30-day channel for the review and approval of drug clinical trial applications supports national key research and development varieties, encourages global early synchronous research and development and international multi-center clinical trials, and serves clinical urgent needs and the development of the national pharmaceutical industry.
The draft for comments proposes that applications for inclusion in the 30-day channel for the review and approval of innovative drug clinical trials should be for traditional Chinese medicines., Chemicals, Biological ProductsCategory 1 innovative drugs can submit application materials as required and must meet one of the following conditions: First, key innovative drugs supported by the state. Key innovative drugs with obvious clinical value that are supported by the national full-chain policy system to support the development of innovative drugs. Second, varieties selected for the Children's Drug Starlight Program and Rare Disease Care Program of the Drug Review Center of the National Drug Administration. Third, varieties developed simultaneously around the world. Phase I, Phase II clinical trials and Phase III international multi-center clinical trials developed simultaneously around the world, as well as international multi-center clinical trials led by major Chinese researchers.
The draft for comments mentioned that drug clinical trial applicants included in the 30-day channel shall submit application materials to the Drug Review Center of the National Drug Administration to prove that the ethical review, principal investigator capabilities and compliance of the lead unit of the drug clinical trial institution have been fully examined; before submitting the clinical trial application, they have cooperated with the drug clinical trial institution to simultaneously carry out project establishment and ethical review; they have the risk assessment and management capabilities of the research and development process that are commensurate with the research and development risks of the applied product, and promise to start the clinical trial within 12 weeks after approval (the first subject signs the informed consent form).
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