Q5E (edition Step 4, 18 November 2004) is Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process. Sets out principles for judging whether a biotechnology product is comparable before and after a change in its manufacturing process, with the main emphasis on quality aspects.

Which markets recognize Q5E?

United States: adopted, national code Vol. 70, No. 125, p. 37861-2; European Union: adopted, national code CPMP/ICH/5721/03; United Kingdom: adopted; Japan: adopted, national code PFSB/ELD Notification No. 0426001; China: adopted, national code NMPA, China Announcement No. 7 (2020); Canada: adopted, national code File #: 15-107053-353; Brazil: adopted, national code RDC 413/2020; 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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Q5E (Step 4, 18 November 2004)

Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process

ICHICH guidelineOtherBiologicsHigh confidenceLast verified October 4, 2026

Sets out principles for judging whether a biotechnology product is comparable before and after a change in its manufacturing process, with the main emphasis on quality aspects.

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. 70, No. 125, p. 37861-2	Effective June 1, 2005
European Union	Adopted	-	CPMP/ICH/5721/03	Effective June 1, 2005

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.