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Guideline_on_xenogeneic_cell-based_medicinal_products
[PDF, 122.87 KB]
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
TGA annotations:
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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For more information see International scientific guidelines adopted in Australia.