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Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products

We have adopted this International Scientific Guideline - EMA/CHMP/BPWP/144533/2009 rev 1)

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About this guideline

Overseas effective date:  1 May 2016

Replaces: EMA/CHMP/BPWP/144533/2009 Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products (adopted by TGA 1 June 2014)

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.
  • All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.

For more information see International scientific guidelines adopted in Australia.

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