The Therapeutic Goods Administration is experiencing system issues linked to global Microsoft outages. Some services may be disrupted and we may take longer to respond to email and phone contact during this time.
Adopted by the TGA: 26 June 2024
Overseas effective date: 28 February 2018
Replaces: CPMP/ICH/2711/99
Categories: ICH | Efficacy | Clinical trials
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.