Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.

Join

Subscribe or Register

Existing user? Login

Medicines licensing

Patients to get a voice in European Medicines Agency pilot

Guido Rasi, executive director of the European Medicines Agency (EMA), which is inviting patients to evaluate some medicines

Source: European Medicines Agency (EMA)

Guido Rasi, executive director of the European Medicines Agency, says involving patients in the regulator’s discussions ultimately contributes to the safe and rational use of medicines

Patients will for the first time be invited to give their views on the benefits and risks of some medicines in meetings with the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

The pilot scheme, which will run for at least a year, is part of the EMA’s push to involve patients more in the assessment of medicines throughout their lifecycle and increase transparency. It will include new medicines for which there is an unmet medical need or concerns by the CHMP; and possibly on authorised medicines where the CHMP is considering recommending withdrawing or suspending a product.

“As patients live with their condition on a day-to-day basis, their views on the therapeutic effect of a medicine and its impact on their quality of life — particularly when these are balanced against the risks — may differ from those of other stakeholders,” says Guido Rasi, executive director of the EMA. “Involving patients in CHMP discussions brings the patients’ voice into the decision-making process and ultimately contributes to the safe and rational use of medicines.”

The first medicine to be looked at in the pilot is intended for the treatment of a rare genetic blood disorder that causes an absolute intolerance to light and for which there is no authorised treatment. It contains the active ingredient afamelanotide.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.20066658

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • BNF and BNF for Children

    BNF and BNF for Children

    Now available as a 1 year print subscription to both the BNF and BNFC, ensuring you have the latest medicines information as it publishes and at a greatly reduced price.

    £138.50Buy now
  • BNF and BNF for Children

    BNF and BNF for Children

    Now available as a 2 year print subscription to both the BNF and BNFC, ensuring you have the latest medicines information as it publishes and at a greatly reduced price.

    £262.50Buy now
  • Pharmaceutical Toxicology

    Pharmaceutical Toxicology

    Explains the methodology and requirements of pre-clinical safety assessments of new medicines. Includes registration requirements and pharmacovigilance.

    £40.00Buy now
  • Strategic Medicines Management

    Strategic Medicines Management

    A practical guide to influencing the availability of medicines, and policies of their use. Focuses on the strategic elements of medicines management.

    £33.00Buy now
  • Sport and Exercise Medicine for Pharmacists

    Sport and Exercise Medicine for Pharmacists

    All the information you need to provide patients with evidence-based advice on sports and exercise related health matters.

    £27.00Buy now

Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Jobs you might like

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.