The European Medicines Agency (EMA) released the draft ICH guideline E6 on good clinical practice (GCP) in June 2021.
The International Council for Harmonisation (ICH) is committed to developing technical requirements for pharmaceuticals for human use in a manner that is responsive to the needs of the global community. This guideline is currently under development by the ICH E6(R3) Expert Working Group (EWG) that is organising a web conference to present the draft of the GCP as a work in progress.
The renovation of GCP will align its principles with ICH E8(R1) Revision of General Considerations for Clinical Studies, in particular for clinical trials quality, stakeholder engagement, trial design, proportionate trial management. ICH E6(R3) will also provide additional considerations for non-traditional interventional trials.
Stay tuned for further updates!