2025年1月14日，人用药品技术要求国际协调理事会(ICH)官方发布了ICH E6 (R3)终稿。本次修订后，ICH GCP E6(R3)已经到达第四阶段。Step 4的最终文件由ICH大会的监管成员作为ICH harmonised guideline在Step 4阶段采纳，即将进入Step 5 Implementation 正式实施。E6(R3)强调简单高效 ...

Good Clinical Practice (GCP) is a set of guidelines agreed at the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use.1 The ...

In 1996, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) developed “Guidance for Industry Good Clinical Practice (ICH ...