Public Consultation: ICH Guidelines on terminology used for Pharmacogenomics

Dear Colleague,

I am writing to you in your capacity of coordinator of the EuroGenetest network. As per our correspondence dated 19 July 2006 I am pleased to confirm that a new harmonised guideline on the terminology used in Pharmacogenomics is now available for public consultation until end of February 2007.

The goal of the E15 initiative is to harmonise at international level definitions for Pharmacogenomics, Pharmacogenetics, genomic biomarkers, and relevant sample and data coding. Standardised terminology will be proposed for incorporation in future regulatory documents related to pharmacogenetics and pharmacogenomics.

The consultation period will be relatively short as the finalisation of the ICH guideline is planned towards the 4Q 2007.

Please submit your comments to PGWPSecretariat@emea.eu.intPGWPSecretariat@emea.eu.int by the end of February 2007

Do not hesitate to contact me should you wish to share additional information on the matter.

Best Regards

Marisa Papaluca Amati MD
Deputy Head of Sector
European Medicines Agency
Sector Clinical Safety and Efficacy
Phone +44 207 418 8436
Fax +44 207 418 8613
e-mail: marisa.papaluca@emea.europa.eumarisa.papaluca@emea.europa.eu

Documents

Position Paper on Terminology in Pharmacogenetics