Guideline on clinical investigation of recombinant and human plasma-derived factor IX products - rev. 2

About this guideline

Adopted by the TGA: 24 May 2026

Overseas effective date: 30 June 2024

Replaces: Guideline on clinical investigation of recombinant and human plasma-derived factor IX products (EMA/CHMP/BPWP/144552/2009 Rev. 1, Corr. 1.)

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

TGA annotations: Nil

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.

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For more information see International scientific guidelines adopted in Australia.