February 20, 2014
More and more medicinal products authorized by the European Medicines Agency (EMA) contain pharmacogenomic information in their Summary of Product Characteristics. Pharmacogenomics is the study of variations of DNA and RNA characteristics as related to drug response. Nowadays, pharmacogenomics is part of the development and the marketing (post-authorisation) phase for several medicines.
The EMA published its first pharmacogenomic guideline in 2012, in order to promote the integration of pharmacogenomics in product development for patient treatment. This guideline provides in vitro and in vivo cut-off values to guide industry drug development.
As serious adverse drug reactions have already been identified after marketing authorization, the EMA has draft a second guideline on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products.
With the drafting of these two guidelines, the EMA intends to further enable the potential of pharmacogenomic during drug development and surveillance, and gain insight into the associated scientific challenges such as translating data from pharmacogenomic studies into clinically relevant product information, as well as discuss potential solutions.
It is too early to measure the impact of these guidelines, however, they are expected to improve genomic data-informed drug development and clinical experience so that patients and public can benefit from the advancements of genomic science and technology.
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Access the EMA guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products
Access the EMA guideline on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products