EMA - Draft ICH E6 (R3) guideline on good clinical practice – step 2b

14th June 2023

The European Medicines Agency has published for public consultation a “Draft ICH E6 (R3) guideline on good clinical practice – step 2b”.

The objective of this ICH GCP Guideline is to provide a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities.

This guideline builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies. This includes fostering a quality culture and proactively designing quality into clinical trials and drug development planning, identifying factors critical to trial quality, and engaging stakeholders, as appropriate, using a proportionate risk-based approach.

Clinical trials vary widely in scale, complexity and cost. Careful evaluation of the priorities involved in each trial and the risks associated with the priorities will help ensure efficiency by focusing on activities critical to achieving the trial objectives

Comments should be provided using this template and sent to iche6_r3@ema.europa.eu by 26 September 2023.

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