Guideline on xenogeneic cell-based medicinal products

We have adopted this International Scientific Guideline - EMEA/CHMP/CPWP/83508/2009

Last updated

29 August 2024

About this guideline

Overseas effective date: 1 January 2010

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

Multidisciplinary | Cell therapy and tissue engineering

Sponsors should refer to the prevailing TGA requirements for minimising the risk of transmitting transmissible spongiform encephalopathies: 'Transmissible Spongiform Encephalopathies (TSE): TGA approach to minimising the risk of exposure'.

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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