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Guideline on potency testing of cell based immunotherapy medicinal products for the treatment of cancer

We have adopted this International Scientific Guideline - EMA/CHMP/BWP/271475/2006 rev.1 

Last updated

About this guideline

Overseas effective date: 1 September 2016

Replaces: CHMP/BWP/271475/2006 Guideline on Potency Testing of Cell Based Immunotherapy Medicinal Products for the Treatment of Cancer (adopted by TGA 29 June 2009)

Categories: Biologicals | Active substance | Manufacture, characterisation and control of the active substance, and Multidisciplinary | Cell therapy and tissue engineering

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
  • All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.

For more information see International scientific guidelines adopted in Australia.

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