Guideline on the evaluation of anticancer medicinal products in man

We have adopted this International Scientific Guideline - EMA/CHMP/205/95 Rev. 5

Last updated

17 July 2024

About this guideline

Adopted by the TGA: 26 June 2024

Overseas effective date: 01 April 2018

Replaces: EMA/CHMP/205/95/Rev.4

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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