International scientific guideline: Radiopharmaceuticals based on monoclonal antibodies

About this guideline

TGA adopted date: 12 Feb 2002

Categories: Quality | Specific types of products

Access this international scientific guideline

Further information

Effective 6 January 2017: the quality aspects of this guideline have been replaced by EMA/CHMP/BWP/532517/2008 Guideline on development, production, characterisation and specification for monoclonal antibodies and related products.

For more information see International scientific guidelines adopted in Australia.

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.