Evaluation of anticancer medicinal products in man

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Current effective version

Revision 4 - Adopted guideline

Currently under revision - see below

Reference numberCHMP/205/95 Rev. 4
Effective from01/07/2013
KeywordsCancer, malignancy, biomarker, targeted drugs, pharmacogenomics
DescriptionThis document provides guidance on the clinical development for the treatment of malignancies, including drug resistance modifiers or normal tissue protective compounds. Read together with answers from the CHMP SAG for Oncology for revision of the anticancer guideline.

Document history

Revision 5

In progress

Adopted guideline



Draft guideline

Concept paper

Published: 20/11/2017

Effective from: 01/04/2018


Published: 15/03/2016

Deadline for comments: 15/09/2016

Published: 30/04/2015

Revision 4 

Current version

Adopted guideline

Draft guideline

Concept paper

In operation: 01/07/2013–present

Published: 22/12/2011

Published: 17/09/2010

Revision 3Adopted guidelineIn operation: 01/06/2006-01/07/2013

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