International scientific guideline: ICH Topic Q 5 D - Note for guidance on quality of biotechnological products: Derivation and characterisation of cell substrates used for production of biotechnological/biological products

About this guideline

Overseas effective date: 1 Oct 1999

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.