16 Sep FDA Publishes ICH E6(R3): What it Means for U.S. Clinical Trials

By Beth Bieze, ACRP

The global clinical research community has been watching closely for the release of ICH E6(R3) Good Clinical Practice (GCP), the long-awaited update to the foundational guideline for clinical trials from the International Council on Harmonization (ICH). On September 9, 2025, the U.S. Food and Drug Administration (FDA) posted the final version of ICH E6(R3) on its website and published it in the Federal Register. This publication signals that the guideline is officially available in the United States and provides a clear reference point for industry and regulators alike. 

While this is a significant step, it is important to note that FDA guidance documents are not legally binding. They represent the agency’s current expectations and recommendations but do not themselves establish enforceable obligations. Unlike the European Medicines Agency—which made E6(R3) effective on July 23, 2025—the FDA has not yet set a formal compliance date for U.S. organizations. Still, publication in the Federal Register makes one thing clear: the time to prepare is now. Read more…