Which markets recognize Q8(R2)?

United States: adopted, national code Vol. 71, No. 98; European Union: adopted, national code CHMP/ICH/167068/2004; United Kingdom: adopted; Japan: adopted, national code PFSB/ELD Notification No. 0628-1; China: adopted, national code NMPA, China Announcement No. 6 (2020); Canada: adopted, national code File #: 16-101390-659; Brazil: adopted, national code RESOLUÇÃO RDC Nº 658/2022; South Korea: adopted; Switzerland: adopted; Mexico: not recognized; Saudi Arabia: adopted; Singapore: adopted; Taiwan: adopted.

Metric	Value	Period
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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John HoneypotCEO9999999999999
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Q8(R2) (Step 4, 1 August 2009)

Q: What is Q8(R2)?

Q8(R2) (edition Step 4, 1 August 2009) is Pharmaceutical Development. Gives guidance on what goes into section 3.2.P.2 (Pharmaceutical Development) of the quality module for drug products. It does not apply to submissions at the clinical research stages. An annex describes the principles of quality by design.

Pharmaceutical Development

ICHICH guidelineOtherDevices and medicinesHigh confidenceLast verified October 4, 2026

Gives guidance on what goes into section 3.2.P.2 (Pharmaceutical Development) of the quality module for drug products. It does not apply to submissions at the clinical research stages. An annex describes the principles of quality by design.

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. 71, No. 98	Effective November 1, 2009
European Union	Adopted	-	CHMP/ICH/167068/2004	Effective August 1, 2009

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.