The ICH GCP Addendum E6 R(2) is final now!

Global good clinical practice (GCP) guideline amendment adopted

The 1996 ICH guideline on GCP is one of the most significant achievements of the ICH process, establishing harmonised standards for clinical trials. The ICH Assembly adopted an important amendment (ICH E6(R2)) that aims to encourage sponsors to implement improved oversight and management of clinical trials, while continuing to ensure protection of human subjects participating in trials and clinical trial data integrity.This amendment will now be implemented by ICH members through national and regional guidance.

In parallel, the Assembly agreed to look at renewing the wider package of guidelines that relate to GCP and clinical trial design. This will include updating current guidance on interventional trials and expand on novel trial methodologies for drug registration such as non-interventional trials, including use of new data sources such as real world evidence, patient registries, etc.

A reflection paper is expected to be published on the ICH website in early 2017, which will include an outline of the long-term work planning, beginning with revision of the ICH E8 guideline in 2017. ICH recognises the high level of interest in GCP guidance and is committed to working with concerned stakeholders and will be seeking views as work goes forward.