中文版ICH相关指导原则

licf · 发表于 2021-7-21 13:21:41

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比较全面的国际人用药品注册技术协调会ICH指导原则中文版，http://www.cde.org.cn/ichWeb/index.jsp

licf · 发表于 2021-7-21 13:23:33

本帖最后由 licf 于 2021-7-21 13:28 编辑

ICH Official web site : ICH ICH Guidelines

The ICH topics are divided into the four categories below and ICH topic codes are assigned according to these categories.

Quality Guidelines

Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.

Safety Guidelines

ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years.

Efficacy Guidelines

The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/genomics techniques to produce better targeted medicines.

Multidisciplinary Guidelines

Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).

大海 · 发表于 2021-7-21 13:54:47

关注关注

洞大人 · 发表于 2021-7-22 08:53:46

谢谢分享~~

清晨的太阳 · 发表于 2021-7-27 12:57:25

有木有中文版的。

凛h0jkivyv · 发表于 2021-10-15 16:55:25

清晨的太阳发表于 2021-7-27 12:57
有木有中文版的。

蒲公英，，，，

小肥羊212 · 发表于 2023-8-25 11:23:40

太感谢了~~