Which markets recognize Q13?

United States: adopted, national code Vol. 88, No. 40, p. 12941-12942; European Union: adopted, national code EMA/CHMP/ICH/427817/2021; United Kingdom: not recognized; Japan: adopted, national code PSEHB/PED Notification No. 0531-1; China: adopted, national code NMPA, China Announcement No. 158 (2023); Canada: adopted, national code File #: 25-102237-854; Brazil: adopted, national code Guia nº 71/2024 v.01; 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
Jane TrapdataCFO-8888888888

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Q13 (Step 4, 16 November 2022)

Q: What is Q13?

Q13 (edition Step 4, 16 November 2022) is Continuous Manufacturing of Drug Substances and Drug Products. Describes scientific and regulatory considerations for the development, implementation, operation and lifecycle management of continuous manufacturing of drug substances and drug products.

Continuous Manufacturing of Drug Substances and Drug Products

ICHICH guidelineOtherDevices and medicinesHigh confidenceLast verified October 4, 2026

Describes scientific and regulatory considerations for the development, implementation, operation and lifecycle management of continuous manufacturing of drug substances and drug products.

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, No. 40, p. 12941-12942	Effective March 1, 2023
European Union	Adopted	-	EMA/CHMP/ICH/427817/2021	Effective July 10, 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.