International scientific guideline: ICH topic Q 5 B - Quality of biotechnological products: Analysis of the expression construct in cell lines used for production of r-DNA derived protein products

About this guideline

Overseas effective date: 1 May 200

Categories: Biological medicines | Drug substance | Manufacture and characterisation and control of the drug substance

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For more information see International scientific guidelines adopted in Australia.

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.