CTU Bern (Clinical Trials Unit)

ICH asks for comments on GCP Renovation

ICH recently amended its Good Clinical Practice guideline (integrated addendum GCP(R2)). In January 2017, ICH started a new process to potentially modernize the guideline by publishing a Reflection on “GCP Renovation”. The goal of the potential renovation is to provide updated guidance that is both appropriate and flexible enough to address the increasing diversity of study types and data sources that are being employed to support regulatory and other health policy decisions, as appropriate. Stakeholders are invited to comment on the reflection paper. This public consultation is a new approach for ICH and is considered a first step in an enhancement of the ICH process.

Details on the process and the paper itself can be found here.