Good Clinical Practice (ICH E6(R3))

What this entry covers

Good Clinical Practice (GCP) is an international standard for the design, conduct, recording and reporting of clinical trials involving human participants. The current guideline is ICH E6(R3), from the International Council for Harmonisation (ICH); FDA issues it as guidance, and FDA’s own human subject protection regulations (21 CFR Parts 50, 56, 312 and 812) apply to trials under its jurisdiction.

MyRHC indexes this framework so practitioners, auditors, and automated agents can find the authoritative primary sources in one place. This page is a navigation aid; it is not legal advice and is not a substitute for the official text.

Official documentation

• Primary official source: https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/regulations-good-clinical-practice-and-clinical-trials
• FDA guidance: E6(R3) Good Clinical Practice: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r3-good-clinical-practice-gcp
• EMA: ICH E6 Good clinical practice: https://www.ema.europa.eu/en/ich-e6-good-clinical-practice-scientific-guideline

Recent changes

• 2026-06-03: ICH adopted E6(R3) Annex 2 (decentralised and pragmatic trial elements and real-world data) at Step 4. In the EU it takes effect on 15 January 2027 (scheduled date stated by EMA). EMA
• 2025-09: FDA issued ICH E6(R3) Good Clinical Practice as final guidance. FDA
• 2025-07-23: The E6(R3) Principles and Annex 1 came into effect in the EU. EMA

How to use this index entry

1. Open the official link above (or the agency home if the deep link drifts).
2. Confirm edition / revision date against your program scope.
3. Map applicability by sector and jurisdiction listed in the metadata.
4. Follow related frameworks only after checking their own official sources.

Disclaimers

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