Which markets recognize E9(R1)?

United States: adopted; European Union: adopted, national code EMA/CHMP/ICH/436221/2017; United Kingdom: adopted; Japan: adopted, national code PSB/PED Notification No. 0620-1; China: adopted, national code NMPA, China Announcement No. 16 (2021); Canada: adopted, national code File #: 20-109237-45; Brazil: not recognized; South Korea: adopted; Switzerland: adopted; Mexico: not recognized; Saudi Arabia: adopted; Singapore: adopted, national code HSA, Singapore webpage: Guidance documents for clinical trials; Taiwan: adopted, national code Updated-Announcement for ICH Guidelines Recognition List.

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E9(R1) (Step 4, 20 November 2019)

Q: What is E9(R1)?

E9(R1) (edition Step 4, 20 November 2019) is Addendum: Statistical Principles for Clinical Trials. An addendum to the statistical principles guideline that focuses on estimands and sensitivity analysis, mainly for confirmatory clinical trials.

Addendum: Statistical Principles for Clinical Trials

ICHICH guidelineClinical investigationDevices and medicinesHigh confidenceLast verified October 4, 2026

An addendum to the statistical principles guideline that focuses on estimands and sensitivity analysis, mainly for confirmatory clinical trials.

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	-	-	Effective May 11, 2021
European Union	Adopted	-	EMA/CHMP/ICH/436221/2017	Effective July 30, 2020

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.