The European Medicines Agency has published a guideline advising pharmaceutical companies how to integrate studying the role of genetic variability between patients during the development of medicines. The guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products clarifies the requirements for the analysis of the effect of genetic variability on the way the human body handles medicines. 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.
The guideline sets out requirements and recommendations on:
- when pharmacogenetic studies should be performed;
- how these studies should be designed and carried out;
- how the clinical impact of genetic differences between patients should be evaluated;
- how dosing or treatment recommendations for genetic subpopulations should be studied;
- consequences for treatment recommendations and labelling;
- the impact of interactions between medicines and of impaired or immature organ function.
The guideline is was adopted by the Committee for Medicinal Products for Human Use after incorporation of comments from the public consultation phase.
Companies applying for marketing authorisation should follow the guideline from 1 August 2012.