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Guideline on human cell-based medicinal products

We have adopted this International Scientific Guideline - EMEA/CHMP/410869/2006.

Last updated

About this guideline

Overseas effective date:  1 September 2008

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