The Food and Drug Administration is announcing the availability of a final guidance for industry entitled “E6(R3) Good Clinical Practice.” This revision incorporates flexible, risk-based approaches and embraces innovations in trial design, conduct, and technology.
This important milestone marks a significant evolution in the global clinical trial landscape, aiming to modernize GCP principles in alignment with current scientific and technological advances while maintaining a strong focus on quality by design, participant protection, and the reliability of trial results.
Key updates in ICH E6 (R3) include:
- Increasing flexibility to support a broad range of modern trial designs, data sources, and technology.
- Advancing quality by design and risk-based quality management in trial conduct and oversight.
- Clarifying sponsor and investigator responsibilities.
- Promoting proportionality, relevance, and critical thinking throughout the clinical trial lifecycle.
This guideline also incorporates the perspectives of academic clinical trial experts to ensure the practical relevance of its provisions. ICH E6 (R3) is intended to encourage the use of technology and innovations, and it is designed to remain relevant and consistent as technology and methods evolve. The finalized guideline is the result of extensive global stakeholder engagement and public consultation. It reflects a flexible, harmonized framework that will support efficient, high-quality clinical trials across regions.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)External Link Disclaimer, founded in 1990, unites regulators and industry to harmonize drug development. Through consensus-based guidelines, it ensures medicines are safe, effective, high-quality, and efficiently registered worldwide. ICH is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. The ICH’s mission is to achieve greater harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner.