Zdrowie i gospodarka · 08/01/2007

International Conference on Harmonisation; Draft Guidance on E15 Terminology in Pharmacogenomics; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "E15 Terminology in Pharmacogenomics." The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics, and genomic data and sample coding categories. In the effort to develop harmonized approaches to drug regulation, it is important to ensure that consistent definitions of terminology are being applied across all constituents of the ICH. The draft guidance is intended facilitate the integration of the discipline of pharmacogenomics and pharmacogenetics into global drug development and approval processes.