The Guidelines for Individual Safety Reports E2B(R3) Area Implementation was issued on Nov.22, 2019. It aims to promote the transformation and implementation of ICH E2B (R3) guiding principles in China, and promote the timely and effective transmission of pre-market and post-market safety report data, which includes relevant policies, regulations, and measures.
- Local Title:个例安全性报告E2B(R3)区域实施指南
- Country/Region:Chinese Mainland
- Competent Authority: National Medical Products Administration (NMPA); The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
- Type:Guideline
- Status:In force
- Release Date:2019-11-22
- Implementation Date:2019-11-22