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

Drug development

EMA launches Priority Medicines Scheme

A new initiative to support drug companies developing therapies with the potential to address unmet medical needs and bring them to market more quickly has been launched by the European Medicines Agency (EMA).

Companies will be appointed an individual expert from the EMA to guide them in producing robust clinical evidence to support the potential of their products. If a drug is backed by the necessary clinical trial evidence, it could be fast-tracked under the EMA’s accelerated assessment programme for marketing authorisation.

Products likely to be considered under the Priority Medicines Scheme (PRIME) are those that have the potential to provide a major therapeutic advantage over existing treatments or that benefit patients without treatment options. The EMA highlights rare cancers, Alzheimer’s disease and other dementias as possible therapeutic areas. It also suggests that eligible drugs could target a chronic condition like asthma but be administered in a new way to benefit patients.

Launching the scheme on 7 March 2016, the EMA’s executive director Guido Rasi said: “Our goal is to foster better planning of medicine development to help companies generate the high quality data we need to assess quality, safety and efficacy of medicines.”

The EMA says PRIME is different from the existing orphan drugs scheme because orphan drug status is only awarded to products with the potential to treat rare conditions that have an unmet clinical need. Products with orphan drug status are also given long-term marketing advantages, according to an EMA spokesperson.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20200834

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
  • Introduction to Clinical Pharmaceutics (An)

    Introduction to Clinical Pharmaceutics (An)

    This unique textbook covers the role of basic pharmaceutics in clinical outcomes and in explaining the behaviour of medicines in the body.

    £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

Supplementary images

  • European Medicines Agency headquarters

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.