ICH E6(R3) final principles & Annex 1 published
We are pleased to announce that the ICH E6(R3) principles and Annex 1 have been finalised and published on the ICH website. This is a rewrite and reorganisation of the R2 version of the guideline on Good Clinical Practice (GCP), which sets international standards for...
Launch of MSP AG consultation on clinical trials training needs for academia and SMEs | Deadline 11 February 2025 (close of business)
We are pleased to announce the launch of the ACT EU consultation on clinical trials training needs for academia and SMEs. As a reminder, the consultation stems from ACT EU initiative’s Priority Action on clinical trials training aiming to deliver a clinical trials...
Open consultation on ICH E6 (R3) Annex 2
EMA has opened the public consultation on the draft Annex 2 of ICH E6(R3), following its adoption by EMA’s Committee for Medicinal Products for Human Use (CHMP). As part of the ICH E6 suite, this document addresses Good Clinical Practice (GCP), an international...
Upcoming ACT EU Multi-stakeholder Workshop on ICH E6 R3
As part of the published Accelerating Clinical Trials in the EU (ACT EU) multi-annual workplan 2022-2026 and acknowledging the important role of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Efficiency...