--- title: "E6(R3), ICH E6(R3) Good Clinical Practice | MedTech Terms" description: "Revision 3 of the ICH Good Clinical Practice guideline, restructured around principles, modernized for risk-based and decentralized trials, finalized in 2023." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ich-e6-r3#term", "name": "ICH E6(R3) Good Clinical Practice", "alternateName": [ "E6(R3)", "ICH GCP R3" ], "description": "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). 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Standards](/terms?cat=Standards) 6. / 7. ICH E6(R3) Good Clinical Practice [All terms](/terms) Standards [Quality System](/ecosystems/quality-system)[Clinical Evidence](/ecosystems/clinical-evidence)E6(R3) # 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. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed June 20, 2026 ## Definition ICH E6(R3) is the third major revision of the International Council for Harmonisation's [Good Clinical Practice](/terms/gcp) (GCP) guideline. Finalized in January 2025 ( [Step](/terms/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](/terms/rwd) integration, and pragmatic trials). R3 modernizes GCP for digital trials, sponsor-investigator collaboration, [risk-based quality management](/terms/risk-based-monitoring), and the use of electronic systems, making explicit many expectations that were implicit in E6(R2) addendum. What the regulation says Finalized at ICH [Step](/terms/step) 4 in January 2025. FDA, EMA, MHRA, [PMDA](/terms/pmda), Health Canada, [NMPA](/terms/nmpa), and other ICH members are in various stages of regional implementation. Many sponsors are transitioning protocols and SOPs to E6(R3) ahead of mandatory adoption dates. ## What this means in practice Although ICH [GCP](/terms/gcp) is primarily a drug guideline, FDA and [ISO 14155](/terms/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](/terms/pmda)) all adopt ICH guidelines into national policy after [Step](/terms/step) 4 finalization. Common pitfalls - • 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 theme ### Editor's picks · Hand-selected related concepts [ Standards ISO 14155 Good clinical practice for clinical investigations of medical devices. ](/terms/iso-14155)[ Clinical & Trials Decentralized Clinical Trial(DCT) A trial that uses telehealth, home-based assessments, wearables, and direct-to-patient logistics to reduce or eliminate site visits. ](/terms/decentralized-clinical-trial)[ Clinical & Trials Electronic Data Capture(EDC) Software systems used to collect, manage, and report clinical trial data electronically, replacing paper case report forms. ](/terms/edc)[ Commercialization Good Clinical Practice(GCP) International quality standard for designing and conducting clinical trials. ](/terms/gcp) ### More in Standards · Same category [ Standards ASTM F2503 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment. ](/terms/astm-f2503)[ Standards Essential Performance Performance of a clinical function whose loss or degradation would result in unacceptable risk. ](/terms/essential-performance)[ Standards IEC 60601-1 General requirements for basic safety and essential performance of medical electrical equipment. ](/terms/iec-60601-1)[ Standards IEC 60601-1-2 EMC requirements for medical electrical equipment. ](/terms/iec-60601-1-2) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Quality System](/ecosystems/quality-system) - [Clinical Evidence](/ecosystems/clinical-evidence) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ICH· 1 FDA· 1 AAMI· 1 1. [1 ICH E6(R3) Guideline Verified ICH · ich.org ](https://www.ich.org/page/efficacy-guidelines) 2. [2 FDA Implementation of ICH E6(R3) Verified FDA · fda.gov ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r3-good-clinical-practice-gcp) 3. [3 AAMI Standards Verified AAMI · aami.org ](https://www.aami.org/standards) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Implementing this standard on a device program? Blue Goat Cyber helps MedTech teams operationalize cybersecurity standards across the design and post-market lifecycle. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Standards Acronym E6(R3) Sources 3 Updated 6/20/2026 [Compare with another term](/compare?a=ich-e6-r3) Learn in 60 seconds Card Lesson Quiz Revision 3 of the ICH Good Clinical Practice guideline, restructured around principles, modernized for risk-based and decentralized trials, finalized in 2023. - · 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. Remember this Watch out: Treating R3 as a minor update, the principles-based structure represents a meaningful shift in how GCP compliance is demonstrated. Related terms - [Good Clinical Practice(GCP) ](/terms/gcp) - [ICH E6 Good Clinical Practice(GCP) ](/terms/ich-gcp) - [ISO 14155 ](/terms/iso-14155) - [Risk-Based Monitoring(RBM) ](/terms/risk-based-monitoring) - [Decentralized Clinical Trial(DCT) ](/terms/decentralized-clinical-trial) - [Electronic Data Capture(EDC) ](/terms/edc) You may also need Auto-suggested from Standards and shared keywords. - [Pragmatic Trial ](/terms/pragmatic-trial) - [ALCOA+ ](/terms/alcoa-plus) - [ISO 20916 ](/terms/iso-20916) - [Real-World Data(RWD) ](/terms/rwd) - [Threat Modeling ](/terms/threat-modeling) - [ISO 13485 ](/terms/iso-13485) [All Standards terms](/terms?cat=Standards) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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