Q5B (edition Step 4, 30 November 1995) is Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products. Describes the kinds of information that help assess the structure of the expression construct used to make recombinant DNA derived proteins.

Which markets recognize Q5B?

United States: adopted, national code Vol. 61, p. 7006; European Union: adopted, national code CPMP/ICH/139/95; United Kingdom: adopted; Japan: adopted, national code PMSB/ELD Notification No. 3; China: adopted, national code NMPA, China Announcement No. 7 (2020); Canada: adopted, national code Catalogue No. H42-2/67-19-2000E; Brazil: adopted, national code RDC 413/2020; South Korea: adopted; Switzerland: adopted; Mexico: not recognized; Saudi Arabia: adopted; Singapore: adopted; Taiwan: adopted.

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Q5B (Step 4, 30 November 1995)

Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products

ICHICH guidelineOtherBiologicsHigh confidenceLast verified October 4, 2026

Describes the kinds of information that help assess the structure of the expression construct used to make recombinant DNA derived proteins.

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. 61, p. 7006	Effective February 1, 1996
European Union	Adopted	-	CPMP/ICH/139/95	Effective July 1, 1996

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.