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.
|Topic||Documents||Reference number||Publication date||Effective date||Remarks|
|Good pharmacogenomic practice||EMA/CHMP/268544/2016||May 2016||Deadline for comments 16 Sep 2016|
|Key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products||EMA/CHMP/281371/2013||November 2015||1 April 2016|
|Reflection paper on methodological issues with pharmacogenomic biomarkers in relation to clinical development and patient selection||Draft guideline||EMA/CHMP/446337/2011||Released for consultation July 2010||Deadline for comments 25 Nov 2011|
|Reflection paper on co-development of pharmacogenomic biomarkers and assays in the context of drug development||Draft guideline||EMA/CHMP/641298/2008||Released for consultation July 2010||Deadline for comments Nov 2010|
|Use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products||EMA/CHMP/37646/2009||February 2012||1 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 standards||Concept paper||EMEA/CHMP/190395/08||June 2008|
|Reflection paper on pharmacogenomics in oncology||Draft guideline||CHMP/PGxWP/128435/06||Released for consultation April 2008||Deadline for comments Jul 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||CHMP/ICH/437986/06||November 2007||May 2008|
|Reflection paper on pharmacogenomic samples, testing and data handling||EMEA/CHMP/PGxWP/201914/06||November 2007||November 2007|
|Guiding principles: Processing joint Food and Drug Administration and European Medicines Agency voluntary genomic data submissions within the framework of the confidentiality arrangement||Adopted guideline||April 2007|
|Reflection paper on the use of genomics in cardiovascular clinical trials||Concept paper||EMEA/CHMP/PGxWP/278789/06||November 2007||November 2007|
|Reflection paper on the use of pharmacogenetics in the pharmacokinetic evaluation of medicinal products||EMEA/128517/06||April 2007||May 2007|
|Pharmacogenetics briefing meeting||Adopted guideline||CHMP/PGxWP/20227/04||May 2006||November 2006|
|Position paper on terminology in pharmacogenetics||Adopted guideline||EMEA/CPMP/3070/01||November 2002||June 2003|
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