ICH Guideline for Good Clinical Practice E6(R3) Annex 2
The European Medicines Agency has published for public consultation the ICH Guideline for Good Clinical Practice E6(R3) Annex 2 Good Clinical Practice (GCP), as described in ICH E6(R3) Principles and Annex 1, is applicable across clinical trial types, designs and...
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...
IMPORTANT MESSAGE FROM ACT EU
All clinical trials expected to continue beyond 30 January 2025 must be transitioned to the EU Clinical Trials Regulation (CTR) via the Clinical Trials Information System (CTIS). This date marks the end of a three-year transition period that began when the CTR became...