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English Version ICH E5(R1) Ethnic Factors in the Acceptability of Foreign Clinical Data 1. ...
一、概述 (一)前言 为鼓励和促进创新药物的科学研发及申报,加快新药好药上市, 满足患者迫切的临床用药需求,本指导原则基于审评工作实践,系统梳理了新药研发和申报中的常见临床问题,并基于当前法规要...