Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Pharmacogenomic data in the product information of medicinal products ***

Dr. Alexandra Eckhoff (Abschlußjahr: 2014)

Summary
Language: English
In the past years, our understanding of the influence of genes on inter-individual differences in drug action has rapidly been developed. Pharmacogenomics, the science that determines how genetic variability influences physiological responses to medicinal products, has become an internal part of drug development but is also an important instrument in the evaluation of serious adverse drug reactions experienced in clinical routine.
It has been widely acknowledged that pharmacogenomic information included in the product information may be helpful to improve safe and effective use of a medicinal product. The number of product information of medicinal products in which detailed pharmacogenomic information is available has gradually increased over the last years. However, it has been repeatedly demonstrated that the extent and content of pharmacogenomic information for the same active substance may in part be different between regions like United States and European Union.
The present master thesis provides an overview of the regulatory framework on pharmacogenomics in the EU and the USA with focus on guidance provided on including pharmacogenomic information into product information in both regions. Both agencies, the European Medicines Agency and the United States Food and Drug Adminstration, have established relevant expertise and a regulatory framework for generation of pharmacogenomic data and many of the available guidance documents in this area also provide advice on how to include pharmacogenomic data in the product information.
However, an analysis of pharmacogenomic information with regard to the drug-metabolising enzyme CYP2C19 provided in the European Summary of Product Characteristics and in the US prescribing information of a selected number of active substances also presented in this master thesis confirmed that pharmacogenomic information still varies in part significantly between both regions for the same active substance.
Regulators contribute to the process of generating pharmacogenomic data and in the next step of translation of respective results into clinical practice. With regard to labelling, the assessment of current regulatory guidance did not reveal any significant differences in the pre-requisites between the regions. However, it appears that difference in the assessment and interpretation of PGx data occurs among regions which lead to the conclusion that improvement towards a more similar approach of evaluation is still necessary. Regulatory differences should be avoided as they are hardly to understand, produce uncertainty and, at the worst, may result in treatment errors. Cooperation between regulatory agencies should be intensified in this context not only by improving existing platforms. It is further proposed to develop the idea of a “decision framework” to support regulators in their decision making to ensure finally that consistent information is provided to healthcare professionals.
Pages: 46, Annexes: 1, pages : 20