International scientific guideline: ICH topic Q5E - comparability of biotechnological/ biological products note for guidance on biotechnological/biological products subject to changes in their manufacturing process

About this guideline

Overseas effective date: 26 March 2010

Categories: Biological medicines | Drug substance | Comparability/biosimilarity | Multidisciplinary | Biosimilars | Other relevant guidelines

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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.