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About this guideline
Adopted by the TGA: 13 March 2025
Overseas effective date: 18 November 2023
Replaces: Guideline on the evaluation of anticancer medicinal products in man (EMA/CHMP/205/95 Rev. 5) (Adopted by the TGA 26 June 2024)
Categories: Clinical efficacy and safety | Antineoplastic and immunomodulating agents
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.
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For more information see International scientific guidelines adopted in Australia.