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EMA's concept paper on pharmacogenomics in evaluation of authorised medicines


The EMA has recently published a concept paper, the purpose of which is to develop a guideline on the evaluation of pharmacogenomic methodologies in the evaluation of authorised medicines for public consultation. 


There has been a lot of talk about genetics and how differences can result in one patient's response to drug therapy being very different to another patient.  What we really talking about here is the next step towards "personalised medicine".


Interestingly at the GP-TCM conference held in Braga (Portugal) last year Professor Olavi Pelkonen (Dept. of Pharmacology and Toxicology, University of Oulu, Finland) gave a presentation entitled 'Omics' in regulation of drugs and its implication on the R&D of complex herbal products (CHMs). 


In this he explained that, currently, there are no requirements to perform and include omics-based studies in dossiers being submitted to EU regulatory agencies.  Interestingly, however, the agencies have acknowledged that such studies are being conducted (and increasingly so) and it is encouraged that this study information should be included in the dossier but as supplementary material.


With the publication of this concept paper for consultation (ending 15 March 2012) it'll be interesting to see to what extent 'omics' techniques will be used for the regulation of pharmaceuticals.


Author: Greer Deal, Director of Global Regulatory Services (GRS)