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About this guideline
Overseas effective date: 1 November 2016
Categories: Biologicals | Active substance | Manufacture, characterisation and control of the active substance.
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.
- Important Note: Refer to TGA position statement regarding mRNA technology
For more information see International scientific guidelines adopted in Australia.