EMA Guidance on Genetic Variability - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

EMA Guidance on Genetic Variability

The EMA has published a guideline that addresses the influence of patients’ genetic variability on drug pharmacokinetics. The guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products clarifies the requirements for drug developers to analyse the effect of genetic variability on their medicines. Adopted by the EMA’s Committee for Medicinal Products for Human Use in January following a public consultation, the guideline is expected to come into effect on 1 August 2012.

Genetic variation can affect the body’s absorption, distribution, metabolism and excretion of medicines, which can subsequently impact a medicine’s benefits and risks. Although pharmacogenetics are not equally important for every drug, the guideline recommends that prospective banking of DNA for genotype analyses be conducted in all clinical phases of development. Even if there is no obvious indication of a genetic influence on pharmacokinetics, effects may be identified at later stages of development or in postmarketing, which was the case for tamoxifen and clopidogrel where activation by polymorphic enzymes was identified during pharmacovigilance monitoring.

According to the guidance, studies of the effect of pharmacogeneitcs will usually be required when the magnitude of interindividual variation in drug exposure is high enough to potentially affect a medicine’s safety and/or efficacy. The guideline provides recommendations on where pharmacogenetics should be implemented into the drug development process and applies mainly to small-molecule drugs, as the genetic effects on the pharmacokinetics of biological drugs are not yet as well understood.

The guideline also addresses:

  • recommendations and requirements for study designs, subject selection and sampling
  • how to evaluate the clinical impact of genetic differences between patients and recommendations for further studies
  • possible consequences of differences and the impact on treatment recommendations and labelling
  • consideration of drug–drug interactions
  • effects of impaired or immature organ functions on pharmacogenetics related pharmacokinetic studies.

The full guideline can be read on the EMA website.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality

Click here