International scientific guideline: ICH Topic Q 5 A (R1) - Note for Guidance on Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

About this guideline

Overseas effective date: 1 May 2000

Categories: Biological medicines | Drug product | Adventitious agents safety evaluation viral safety

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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.