Evaluation of anticancer medicinal products in man

Current effective version

PDF iconRevision 4 - Adopted guideline

Currently under revision - see below

Reference numberCHMP/205/95 Rev. 4
Published11/01/2013
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 PDF icon answers from the CHMP SAG for Oncology for revision of the anticancer guideline .


Document history

Revision 5

In progress

PDF iconAdopted guideline

PDF iconDraft guideline



PDF iconConcept 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

PDF iconAdopted guideline


PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/07/2013–present


Published: 22/12/2011


Published: 17/09/2010

Revision 3 PDF iconAdopted guideline In operation: 01/06/2006-01/07/2013


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