The European Medicines Agency (EMA) has opened an an online consultation on its concept paper on the revision of the guideline on good pharmacogenomic practice.
The ‘Guideline on Good Pharmacogenomic Practice’ outlines the requirements for selecting appropriate genomic methodologies during the development and life cycle of a drug. It sets out the principles for robust clinical genomic datasets. It also emphasises the key scientific and technological considerations involved in determining and interpreting genomic biomarker data, and in translating this information into clinical practice.
The proposed revised guideline will replace the ‘Guideline on good pharmacogenomic practice’ (EMA/CHMP/718998/2016).
Comments can be submitted until 31 March 2026 via the EU Survey.