美國食品藥品監(jiān)督管理局（FDA）于2023年5月發(fā)布了行業(yè)用“藥物非臨床普遍接受的科學知識指導原則草案”，旨在幫助企業(yè)確定是否可以依賴普遍接受的科學知識（GASK）以滿足新藥上市申請的技術要求。該指導原則通過舉例說明了申請人在兩種情況下可以依賴GASK用于支持藥物上市，而不需開展某些非臨床研究。該指導原則可以簡化相關新藥的研究和評價，加速藥物上市，期望相關原則有助于國內對這類新藥的研發(fā)與監(jiān)管。

Food and Drug Administration (FDA) issued a draft guidance which entitled "Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information Guidance for Industry" at May 2023. It is designed to assist sponsors determining whether it is appropriate to rely on generally accepted scientific knowledge (GASK) to meet the approval requirements for New Drug Application (NDA) or Biologics Licensing Application (BLA). The guidance described two circumstances in which applicants can rely on GASK to support drug approval without conducting certain non-clinical studies. The guidance can simplify the research and evaluation of the related new products, and accelerate the approval of new drugs or biologics, and it is expected that the relevant principles will be helpful for the research and regulation of the related new products in China.

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