International – E6(R3): ICH releases draft of overhauled GCP guideline for consultation

The International Council for Harmonisation (ICH) on Tuesday published the long-awaited draft version of its ICH E6(R3) guideline on good clinical practice (GCP) for consultation by its regulatory members. Alongside the draft guideline, ICH announced it has begun work on a second annex to the document, following the adoption of an Annex 2 concept paper by its management committee earlier this month.

The third revision of the seminal international GCP guideline kicked off in 2019, three years after the international harmonization body adopted the current version of the guideline, E6(R2), which added an integrated addendum to the document focused on efficient trial design, conduct, oversight and reporting. While the R2 version was developed to account for emerging technologies and electronic data sources, ICH felt the need to update the document to further address innovative trial designs, diverse data sources and to align the guideline with its recent E8(R1) General Considerations for Clinical Studies