Multidisciplinary: Pharmacogenomics

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This page lists the scientific guidance documents on pharmacogenomics.

If you have comments on a document which is open for consultation, please use the form for submission of comments on scientific guidelines.

TopicDocumentsReference numberPublication dateEffective dateRemarks
Good genomics biomarker practicesConcept paperEMA/CHMP/PGWP/415990/2014August 2014 Deadline for comments 04 November 2014
Key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products

Draft guideline

Concept paper

EMA/281371/2013Released for consultation January 2014 Deadline for comments 30 July 2014
Reflection paper on methodological issues with pharmacogenomic biomarkers in relation to clinical development and patient selectionDraft guidelineEMA/CHMP/446337/2011Released for consultation July 2010 Deadline for comments 25 November 2011
Reflection paper on co-development of pharmacogenomic biomarkers and assays in the context of drug developmentDraft guidelineEMA/CHMP/641298/2008Released for consultation July 2010 Deadline for comments November 2010
Use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products

Adopted guideline

Draft guideline

Concept paper

EMA/CHMP/37646/2009February 20121 August 2012 
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use concept paper on pharmacogenomic biomarker qualification: Format and data standardsConcept paperEMEA/CHMP/190395/08June 2008  
Reflection paper on pharmacogenomics in oncologyDraft guidelineCHMP/PGxWP/128435/06Released for consultation April 2008 Deadline for comments July 2008
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Topic E15 definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories

Adopted guideline

Draft guideline

CHMP/ICH/437986/06November 2007May 2008 
Reflection paper on pharmacogenomic samples, testing and data handling

Overview of comments

Adopted guideline

EMEA/CHMP/PGxWP/201914/06November 2007November 2007 
Guiding principles: Processing joint Food and Drug Administration and European Medicines Agency voluntary genomic data submissions within the framework of the confidentiality arrangementAdopted guideline April 2007  
Reflection paper on the use of genomics in cardiovascular clinical trialsConcept paperEMEA/CHMP/PGxWP/278789/06November 2007November 2007 
Reflection paper on the use of pharmacogenetics in the pharmacokinetic evaluation of medicinal products

Overview of comments

Adopted guideline

Draft guideline

EMEA/128517/06April 2007May 2007 
Pharmacogenetics briefing meetingAdopted guidelineCHMP/PGxWP/20227/04May 2006November 2006 
Position paper on terminology in pharmacogeneticsAdopted guidelineEMEA/CPMP/3070/01November 2002June 2003