摘要
生殖毒性试验是药物非临床安全性评价的重要内容。我国于2017年加入ICH后,对申请临床试验和上市的生殖毒性的阶段性要求可参考ICH M3(R2)指导原则。根据药物开发的研究人群和开发阶段所致生殖毒性风险的不同,加上临床试验过程中严格的生殖毒性风险控制措施,可分阶段提供支持相应临床试验和上市的生殖毒性试验。本文阐述ICH M3(R2)中支持不同药物开发阶段的生殖毒性试验要求,以及在该指导原则实施过程中需要关注的问题。
The reproductive and developmental toxicity studies are important parts of non-clinical safety studies for human pharmaceuticals.After China CFDA(now NMPA)joined in ICH in 2017,the timing for conduct of reproductive and developmental toxicity studies for supporting different phase clinical trials and new drug application(NDA)can refer to ICH M3(R2)guidelines.Based on different degrees of the reproductive toxicity risk which are dependent on study populations and phases of pharmaceutical development,in addition to strict measures of reproductive toxicity risk control during the process of clinical trials,the reproductive and developmental toxicity studies can be conducted step by step for supporting to corresponding clinical trials and marketing authorization.This article describes the requirements for reproductive and developmental toxicity studies described in ICH M3(R2)guidance to support different phases of drug development,and some main points that need to be paid attention during the implementation of the guidance.
作者
黄芳华
王庆利
王海学
韩玲
HUANG Fang-hua;WANG Qing-li;WANG Hai-xue;HAN Ling(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2020年第1期22-26,共5页
Chinese Journal of New Drugs
