International scientific guideline: ICH topic Q 6 B - Note for guidance on specifications: Test procedures and acceptance criteria for biotechnological/biological products

About this guideline

Overseas effective date: 1 May 2000

Categories: Biological medicines | Drug substance | Specifications

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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.