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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.