EMA publishes guidance on personalised medicines
Looks at studies into how genetic variability can have an impact on drugs’ effects
The European Medicines Agency (EMA) has released guidance that will help pharmaceutical firms to develop personalised medicines. It advises how manufacturers should integrate their development of new medicines with studies into how genetic variability can have an impact on the efficacy of these drugs.
‘This includes how genetic variation can affect the absorption, distribution, metabolism and excretion of medicines by the body, which can in turn lead to differences in the benefits and risks of a medicine between individuals,’ said EMA.
The guidance includes notes on when pharmacogenetic studies should be undertaken during medicine development; how the clinical impact of genetic differences between patients should be assessed; on potential consequences regarding treatment recommendations and labelling; and more. The agency said the guidance should be followed from 1 August.