FDA Adopts Final Version of ICH E6(R3) Good Clinical Practice Guideline
Exciting news for the clinical research community: On September 9, 2025, the U.S. Food and Drug Administration (FDA) published the final ICH E6(R3) Good Clinical Practice (GCP) guideline in the Federal Register — marking a major milestone in modernizing clinical research oversight with its adoption by the Agency.
Key updates in ICH E6(R3):
• Greater flexibility to accommodate diverse trial designs, data sources, and technologies
• Enhanced focus on quality by design and risk-based quality management
• Clearer delineation of sponsor and investigator responsibilities
• Emphasis on proportionality, relevance, and critical thinking across the trial lifecycle
While ICH E6(R3) applies to pharmaceutical clinical trials, its principles—particularly around risk-based quality, data integrity, and technology integration—strongly influence how medical device clinical investigations are designed and managed. Device-focused organizations should continue to follow applicable regulations while embracing the spirit of these modernized GCP principles.
The FDA’s adoption of E6(R3) signals a clear shift toward a risk-based, technology-inclusive era in U.S. clinical research. With E6(R3) in place, now is the time for organizations to begin aligning processes and systems.
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