ICH E6(R3) Good Clinical Practice
Revision 3 of the ICH Good Clinical Practice guideline, restructured around principles, modernized for risk-based and decentralized trials, finalized in 2023.
Definition
ICH E6(R3) is the third major revision of the International Council for Harmonisation's Good Clinical Practice (GCP) guideline. Finalized in January 2025 (Step 4), it restructures GCP as a principles-based framework with two annexes: Annex 1 (interventional clinical trials) and Annex 2 (additional considerations for non-traditional designs including decentralized trials, real-world data integration, and pragmatic trials). R3 modernizes GCP for digital trials, sponsor-investigator collaboration, risk-based quality management, and the use of electronic systems, making explicit many expectations that were implicit in E6(R2) addendum.What this means in practice
Although ICH GCP is primarily a drug guideline, FDA and ISO 14155 reference it for device trials and many medical device sponsors voluntarily follow it for global consistency. For sponsors running multinational device trials, alignment between ISO 14155:2020 and ICH E6(R3) governance models is essential. Regulators (FDA, EMA, MHRA, PMDA) all adopt ICH guidelines into national policy after Step 4 finalization.- •Treating R3 as a minor update, the principles-based structure represents a meaningful shift in how GCP compliance is demonstrated.
- •Maintaining E6(R2)-style SOPs after R3 adoption, many R2 prescriptive requirements no longer apply directly and must be re-evidenced against principles.
- •Ignoring Annex 2, sponsors using decentralized or RWD-integrated designs need it.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsGood clinical practice for clinical investigations of medical devices.
A trial that uses telehealth, home-based assessments, wearables, and direct-to-patient logistics to reduce or eliminate site visits.
Software systems used to collect, manage, and report clinical trial data electronically, replacing paper case report forms.
International quality standard for designing and conducting clinical trials.
More in Standards
· Same categoryStandard practice for marking medical devices and other items for safety in the magnetic resonance environment.
Performance of a clinical function whose loss or degradation would result in unacceptable risk.
General requirements for basic safety and essential performance of medical electrical equipment.
EMC requirements for medical electrical equipment.
Primary references
3 sources- 1
ICH E6(R3) GuidelineVerifiedICHich.org
- 2
FDA Implementation of ICH E6(R3)VerifiedFDAfda.gov
- 3
AAMI StandardsVerifiedAAMIaami.org
Inline markers like [1] jump to the matching reference above.