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Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man

Condition specific guidance

We have adopted this International Scientific Guideline - EMA/CHMP/703715/2012 Rev.2.

Last updated

About this guideline

Overseas effective date: 1 July 2016

Replaces: EMA/CHMP/703715/2012 Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man Condition Specific Guidance (Adopted by TGA 1 April 2014)

Categories: Clinical efficacy and safety | Antineoplastic and immunomodulating agents

TGA annotations

Part 7 on minimal residual disease as an endpoint in chronic lymphocytic leukaemia studies is not currently adopted.

  • 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.

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