Thursday, 30. January 2025
Breaking News: Timelines for ICH GCP E6 R3
Recent Publication
The revised ICH GCP guideline (without Annex 2) has been finalized and published. The European Medicines Agency (EMA) is currently working on the EU version, which is due to be published in the coming days. The new regulations will come into force six months after publication. Annex 2 is still undergoing public consultation. The revision should be completed by July, but it is unclear whether it can be adopted before the summer break. The exact timetable depends on the volume of comments received.