From 23 July 2025, a revised version of Good Clinical Practice (GCP) for clinical trials of medicinal products in humans will apply. The new version of this guideline prepared by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) with the official designation ICH E6 (R3) replaces the previous version (R2). The previously very concise basic principles have been formulated in more detail for the new version of the guideline and now represent the core document of GCP. This is supplemented by annexes that serve to interpret and apply the basic principles. Annex 1, which has already been finalised, focuses on interventional clinical trials. In terms of content, the newly formulated basic principles an Annex 1 replace the previous GCP version (R2). Annex 2 will soon complete the new GCP guideline. It will deal with additional considerations for special study designs, such as decentralised studies, pragmatic studies and studies with real-world data. The new GCP version (R3) is more closely linked to the ICH guidleine E8 (R1) on general considerations for clinical trials.

Presentations and videos of an EMA workshop from February 2025 on the new GCP version (basic principles an Annex 1) can be found here.