ICH E6 (R3) Guideline on good clinical practice (GCP)

International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use

GOOD CLINICAL PRACTICE (GCP) E6(R3) Step 5

23 January 2025. Date for coming into effect 23 July 2025

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 and methodological advancements. This guideline provides a new language to facilitate innovations in clinical trial design, technology, and operational approaches. It encourages a risk-based and proportionate approach to conducting clinical trials, promoting fit-for-purpose solutions. It fosters transparency through clinical trial registration and result reporting and offers additional guidance to enhance the informed consent process.​

The overarching principles and Annex 1, adopted by ICH and CHMP, came into effect on 23 July 2025.

With the public consultation now concluded, the Annex 2 is expected to be finalised later in 2025.

 

TABLE OF CONTENTS

I. INTRODUCTION 
II. PRINCIPLES OF ICH GCP
III.  ANNEX 1
1. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC) 
2.  INVESTIGATOR 
3. SPONSOR 
4. DATA GOVERNANCE – INVESTIGATOR AND SPONSOR
Appendix A. INVESTIGATOR’S BROCHURE
Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)
Appendix C. ESSENTIAL RECORDS FOR THE CONDUCT OF A CLINICAL TRIAL
GLOSSARY

 

© European Medicines Agency, 2025. Reproduction is authorised provided the source is acknowledged.

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