基于美国FDA近五年批准的新药浅谈ICH S1指导原则的实施  

On Implementation of ICH S1 Guideline Based on a Retrospective Analysis of Approved New Drugs by U.S. FDA in the Past Five Years

作　　者：张素才 姚大林 孙云霞 孙涛 Zhang Sucai;Yao Dalin;Sun Yunxia;Sun Tao(JOINN Laboratories(Beijing),Beijing Key Laboratory for Biological Products Safety Evaluation,Beijing 100176,China;Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]北京昭衍新药研究中心股份有限公司,生物制品安全性评价北京市重点实验室,北京100176 [2]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国药事》2019年第11期1295-1309,共15页Chinese Pharmaceutical Affairs

基　　金：国家“重大新药创制”科技重大专项资助项目(编号2018ZX09201-017)

摘　　要：致癌性研究是药物非临床安全性评价的重要内容之一,致癌性试验实施的复杂程度远远超出指导原则的要求。本文对美国FDA在2014-2018年5年期间批准的213个新药进行了梳理和分析,并结合ICH S1要求、文献报道和实际工作经验,从致癌性试验的必要性、致癌性试验结果提交时间、生物制品致癌性试验的决策、致癌性试验的试验类型选择、致癌性试验的剂量设计等几方面提出意见和建议,力求为国内同行、新药研发企业和审评机构提供参考。Carcinogenicity test is one of the important components of nonclinical safety evaluation of drugs.The complexity of the carcinogenicity test is far beyond the requirements of the technical guidance.213 new drugs approved by U.S.FDA from 2014 to 2018 were summarized and analyzed.Combined with the requirements of ICH S1,published literatures and our own experience in JOINN Laboratories,some suggestions were put forward in the following aspects,such as the necessity of carcinogenicity test,the timing of submission of carcinogenicity test results,the decision of carcinogenic test of biological products,the selection of study types for carcinogenicity test and the dose selection of carcinogenicity test in order to provide some references for domestic counterparts,enterprises for research and development of new drugs and drug evaluation agencies in China.

关 键 词：致癌性试验 ICH S1 致癌性试验必要性 剂量选择 Tg.rasH2小鼠 

分 类 号：R994.232[医药卫生—毒理学]