WHO publishes GCP Guidelines for Comment

The WHO has recently published a draft guideline, including two annexes, on Good Clinical Practice (GCP) for clinical trials involving medicinal products. Comments on these documents may be submitted until 6 September 2026. 

Background

The revised WHO GCP Guideline replaces the 1995 version and aligns its core GCP principles with ICH E6 (R3). Using a modular approach, WHO will provide its own implementation guidance to help countries apply these standards across diverse regulatory settings. The update reflects current scientific and regulatory practice, strengthens the ethical conduct, quality and integrity of clinical trials globally, and supports regulatory convergence and appropriate reliance while respecting national autonomy and public-health priorities.

For this consultation, the GCP guideline comprises three parts to be read together:

• The Main principles, establishing the foundations of GCP
• Annex 1, detailing requirements with supporting appendices
• Annex 2, addressing additional considerations focusing on trials that incorporate decentralised elements, pragmatic elements and/or real-world data.

These documents are posted on the WHO Medicines website under "Working documents in public consultation".