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.