The objective of this ICH GCP Guideline is to provide a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory …

Sep 8, 2025 · 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 …

For the most accurate and up-to-date information related to clinical research guidelines and regulations—and tools to navigate the ICH E6(R3) changes—please visit the ACRP …

Jul 1, 2002 · ICH E6 (R3) introduces innovative provisions designed to apply across various types and settings of clinical trials, ensuring continued relevance in the face of ongoing technological …

On January 6, 2025, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) issued its final version of the “Guideline for Good …

Mar 25, 2025 · This document updates the summary of the draft ICH E6 (R3) published on the CT Toolkit in August 2024, incorporating the latest changes from the final version. While this …

Aug 5, 2025 · ICH E6 (R3) is the latest version of guidance to harmonize standards for the design, conduct, recording, and reporting of clinical trials globally. E6 was first issued in 1996 by the …

Jan 14, 2025 · The ICH E6 (R3) “Good Clinical Practice” Guideline provides a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by …

Jan 29, 2025 · The ICH E6(R3) Guideline is structured to provide a comprehensive framework for Good Clinical Practice, consisting of Principles and Annexes that expand on these principles …

Sep 16, 2025 · FDA’s publication of ICH E6 (R3) in the Federal Register marks an important milestone for U.S. clinical research. While the official compliance date remains to be …