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Guideline on development, production, characterisation and specification for monoclonal antibodies and related products

We have adopted this International Scientific Guideline - EMA/CHMP/BWP/532517/2008.

Last updated

About this guideline

Overseas effective date:  1 September 2016

Replaces: EMEA/CHMP/BWP/157653/2007 Guideline on Development, Production, Characterisation and Specifications for Monoclonal Antibodies and Related Products (adopted by TGA 5 August 2009); and the quality requirements for monoclonal antibodies set out in the guideline 3AQ21a Radiopharmaceuticals Based on Monoclonal Antibodies (adopted by TGA 12 February 2002)

Categories: Biologicals | Active substance | Manufacture and 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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