We will have limited operations from 15:00 Tuesday 24 December 2024 (AEDT) until Thursday 2 January 2025. Find out how to contact us during the holiday period.
Guideline on human cell-based medicinal products
[PDF, 168.26 KB]
About this guideline
Overseas effective date: 1 September 2008
Note: To be read in conjunction with the Reflection paper on clinical aspects related to tissue engineered products (EMA/CAT/573420/2009
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.