FDA“药物非临床普遍接受的科学知识指导原则草案”介绍及思考  

Introduction and consideration of FDA's"Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products:Nonclinical Information Guidance for Industry"

作　　者：陈美灵 周植星 CHEN Meiling;ZHOU Zhixing(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《药物评价研究》2024年第8期1702-1705,共4页Drug Evaluation Research

摘　　要：美国食品药品监督管理局(FDA)于2023年5月发布了行业用“药物非临床普遍接受的科学知识指导原则草案”,旨在帮助企业确定是否可以依赖普遍接受的科学知识(GASK)以满足新药上市申请的技术要求。该指导原则通过举例说明了申请人在两种情况下可以依赖GASK用于支持药物上市,而不需开展某些非临床研究。该指导原则可以简化相关新药的研究和评价,加速药物上市,期望相关原则有助于国内对这类新药的研发与监管。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and Drug Administration(FDA)issued a draft guidance which entitled"Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products:Nonclinical Information Guidance for Industry"at May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.

关 键 词：美国食品药品监督管理局 普遍接受的科学知识 新药申请 生物制品许可申请 指导原则 

分 类 号：R951[医药卫生—药学]