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About this guideline
Overseas effective date: June 1995
Categories: ICH | Efficacy
Clinical efficacy and safety | General
TGA annotations:
Attention is drawn to:
- Applicability, Section 7, which states that circumstances exist in which the Guidelines may not be applicable. It should be noted that the listing of exceptional circumstances is not exhaustive. Sponsors should give careful attention to whether, in any particular instance, the clinical safety of the product would be adequately supported by the numbers of subjects proposed, and;
- Supplementary data, Section 8 is NOT ADOPTED. To permit decisions within legislated timeframes, the sponsor should include in the initial submission all clinical safety data necessary to support registration.
- 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.