International scientific guideline: Note for Guidance on the Clinical Investigation of Plasma Derived Antithrombin Products

About this guideline

Overseas effective date: 16 Oct 2003

Categories: Clinical efficacy and safety | Blood products (including biotech alternatives)

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TGA annotations

If a sponsor believes that the patient numbers specified in this guideline are not achievable in Australia, advice should be sought from the TGA.

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.