Which markets recognize E6(R3)?

United States: adopted, national code Vol. 90, No. 172, p. 43460-43462; European Union: adopted, national code EMA/CHMP/ICH/135/1995; United Kingdom: not recognized; Japan: not recognized; China: adopted, national code NMPA, China Announcement No.125 (2025); Canada: adopted, national code File #: 25-105890 – 674; Brazil: not recognized; South Korea: not recognized; Switzerland: adopted; Saudi Arabia: adopted; Singapore: adopted; Taiwan: not recognized.

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Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

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E6(R3) (Step 4, 6 January 2025; Annex 2 adopted 3 June 2026)

Q: What is E6(R3)?

E6(R3) (edition Step 4, 6 January 2025; Annex 2 adopted 3 June 2026) is Good Clinical Practice. A Good Clinical Practice standard for the ethical, scientific and quality conduct of clinical trials with human participants. It sets a flexible, risk-based framework for interventional trials, with an annex on decentralized and pragmatic elements and real-world data.

Good Clinical Practice

ICHICH guidelineClinical investigationDevices and medicinesHigh confidenceLast verified October 4, 2026

A Good Clinical Practice standard for the ethical, scientific and quality conduct of clinical trials with human participants. It sets a flexible, risk-based framework for interventional trials, with an annex on decentralized and pragmatic elements and real-world data.

Recognition by market

Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts

Market	Status	Edition accepted	National code	Details
United States	Adopted	-	Vol. 90, No. 172, p. 43460-43462	Effective September 8, 2025
European Union	Adopted	-	EMA/CHMP/ICH/135/1995	Effective July 23, 2025

Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.