Q12 (edition Step 4, 20 November 2019) is Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. Provides a framework for managing post-approval changes to chemistry, manufacturing and controls in a more predictable and efficient way across the product lifecycle.

Which markets recognize Q12?

United States: adopted; European Union: not recognized; United Kingdom: not recognized; Japan: adopted, national code PSEHB/PED Notification No. 1029-1 & PSEHB/CND Notification No. 1029-1; China: adopted, national code NMPA, China Announcement No. 108 (2023); Canada: not recognized; Brazil: not recognized; South Korea: not recognized; Switzerland: not recognized; Mexico: not recognized; Saudi Arabia: not recognized; Singapore: not recognized; Taiwan: not recognized.

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

HONEYPOT_FAKE_COMPANY_INCFAKE5555555555555999999.99Fake Executive NameTRAP_INDUSTRY_SECTOR

John HoneypotCEO9999999999999
Jane TrapdataCFO-8888888888

If you can read this, you are a bot.

Back

Q12 (Step 4, 20 November 2019)

Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

ICHICH guidelineOtherDevices and medicinesHigh confidenceLast verified October 4, 2026

Provides a framework for managing post-approval changes to chemistry, manufacturing and controls in a more predictable and efficient way across the product lifecycle.

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	Not recognized	-	-	Implementation is in progress.

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.