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Radiopharmaceuticals based on monoclonal antibodies

We have adopted this International Scientific Guideline - 3AQ21a

Last updated

About this guideline

Overseas effective date: January 1992

Replaces: Effective 6 January 2017: the quality aspects of this guideline have been replaced by the  Guideline on development, production, characterisation and specification for monoclonal antibodies and related products (EMA/CHMP/BWP/532517/2008)

Categories: Quality | Specific types of products

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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