Which markets recognize Q9(R1)?

United States: adopted, national code Vol. 88 pg. 28565-28566; European Union: adopted, national code EMA/CHMP/ICH/24235/2006; United Kingdom: adopted; Japan: adopted, national code PSEHB/PED Notification No. 0831-1 & PSEHB/CND Notification No. 0831-2; China: adopted, national code NMPA, China Announcement No. 114 (2023); Canada: not recognized; Brazil: adopted, national code Guia nº 62/2023 versão 01; South Korea: not recognized; Switzerland: adopted; Mexico: adopted; Saudi Arabia: adopted; Singapore: not recognized; Taiwan: adopted, national code Public Announcement for ” List for ICH Guidelines Adopted.”.

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Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

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Q9(R1) (Step 4, 18 January 2023)

Q: What is Q9(R1)?

Q9(R1) (edition Step 4, 18 January 2023) is Quality Risk Management. Gives principles and example tools for quality risk management that can be applied to different aspects of pharmaceutical quality. The R1 revision made limited, specific changes to the earlier Q9 text.

Quality Risk Management

ICHICH guidelineRisk managementDevices and medicinesHigh confidenceLast verified October 4, 2026

Gives principles and example tools for quality risk management that can be applied to different aspects of pharmaceutical quality. The R1 revision made limited, specific changes to the earlier Q9 text.

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. 88 pg. 28565-28566	Effective May 4, 2023
European Union	Adopted	-	EMA/CHMP/ICH/24235/2006	Effective July 26, 2023

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.