Sub menu

 

 

Appendix 1 to the guideline on the evaluation of anticancer medicinal products in man - Methodological consideration for using progression-free survival (PFS) or disease-free survival (DFS) in confirmatory trials

We have adopted this International Scientific Guideline - EMA/CHMP/27994/2008/Rev. 1 

Last updated

 

About this guideline

Overseas effective date: 1 July 2013

Replaces: EMEA/CHMP/EWP/27994/2008 (adopted by TGA 16 March 2009)

Note: To be read in conjunction with Guideline on the evaluation of anticancer medicinal products in man (EMA/CHMP/205/95 Rev.5)

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.
  • 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.

Product types