ICHQ8药物开发指导原则中英文对照.pdf
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- 2016-04-02 发布|
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INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE 人用药物注册技术要求国际协调委员会 ICH HARMONISED TRIPARTITE GUIDELINE ICH 三方协调指导原则 PHARMACEUTICAL DEVELOPMENT 药物开发 Q8(R2) Current Step 4 version dated August 2009 当前Step 4版本发表于2009年8月
This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject
to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process
the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and
USA.
本指导原则由相应的ICH 专家工作团队起草,并且已就ICH 流程的一致性咨询了法规部门。在流
程的Step 4 ,建议本最终版适用于欧盟、日本和美国的法规机构。
版本号:001 翻译时间:2015-12
翻译者:小林 邮箱:xaolin77@sina.com Page 1/40 Q8(R2) Document History 文件日志 First Codification History Date 第一版