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 ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. It aims to provide a unified standard for the ICH regions to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
Specifically, ICH E6 (R3) Annex 2 addresses the GCP considerations that arise from the increased use of a wider range of design elements and data sources. Annex 2 provides additional GCP considerations, focusing on examples of trials that incorporate decentralised elements, pragmatic elements and/or real-world data (RWD). This Annex should be read in conjunction with the ICH E6 (R3) Principles and Annex 1.
All interested stakeholders are invited to submit their feedback on Annex 2 via email to ICHE6_R3@ema.europa.eu using the dedicated comment template no later than 28 February 2025.