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Guideline on Quality of biological active substances produced by transgene expression in animals

We have adopted this International Scientific Guideline - EMA/CHMP/BWP/151897/2013 

Last updated

About this guideline

Overseas effective date: 1 December 2013

Replaces: 3AB7a Use of transgenic animals in the manufacture of biological medicinal products for human use (adopted by TGA 12 February 2002) and concept paper EMEA/CHMP/BWP/134153/2009 on this topic (provided for information 26 March 2010)

Categories: Biologicals | active substance | Manufacture, characterisation and control of the active substance

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.

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