Which markets recognize Q5A(R2)?

United States: adopted, national code Vol. 89, p. 1925 (89 FR 1925); European Union: adopted, national code EMA/CHMP/ICH/804363/2022; United Kingdom: not recognized; Japan: adopted, national code PSB/PED Notification No. 0109-4; China: adopted, national code NMPA, China Announcement No. 63 (2024); Canada: adopted, national code 25-102237-854; Brazil: not recognized; South Korea: adopted; Switzerland: adopted; Mexico: not recognized; Saudi Arabia: adopted; Singapore: adopted; Taiwan: adopted, national code Public Announcement for ” List for ICH Guidelines Adopted.”.

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Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

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Q5A(R2) (Step 4, 1 November 2023)

Q: What is Q5A(R2)?

Q5A(R2) (edition Step 4, 1 November 2023) is Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. Describes how to evaluate the viral safety of biotechnology products made from human or animal cell lines, including viral clearance and testing, and what data go into a marketing application.

Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

ICHICH guidelineOtherBiologicsHigh confidenceLast verified October 4, 2026

Describes how to evaluate the viral safety of biotechnology products made from human or animal cell lines, including viral clearance and testing, and what data go into a marketing application.

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. 89, p. 1925 (89 FR 1925)	Effective January 11, 2024
European Union	Adopted	-	EMA/CHMP/ICH/804363/2022	Effective June 14, 2024

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.