European Medicines Agency [to 12 March 2016]
http://www.ema.europa.eu/

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07/03/2016
Launch of PRIME – Paving the way for promising medicines for patients
New scheme supports European Commission priorities
The European Medicines Agency (EMA) launches today its new PRIME (PRIority MEdicines) scheme to strengthen support to medicines that target an unmet medical need. The scheme focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients with no treatment options. These medicines are considered priority medicines within the European Union (EU).

Through PRIME, EMA offers early, proactive and enhanced support to medicine developers to optimise the generation of robust data on a medicine’s benefits and risks and enable accelerated assessment of medicine applications. This will help patients to benefit as early as possible from therapies that may significantly improve their quality of life.

By engaging with medicine developers early, PRIME aims to strengthen clinical trial designs to facilitate the generation of high quality data for the evaluation of an application for marketing authorisation. Early dialogue and scientific advice also ensure that patients participate in trials that are likely to provide the necessary data for an application for marketing authorisation, and help to make best use of limited resources.

“The launch of PRIME is a major step forward for patients and their families that have long been hoping for earlier access to safe treatments for their unmet medical needs, such as rare cancers, Alzheimer’s disease and other dementias,” says Vytenis Andriukaitis, EU Commissioner for Health and Food Safety. “Through enhanced scientific support this scheme could also help, for example, to accelerate the development and authorisation of new classes of antibiotics or their alternatives in an era of increasing antimicrobial resistance.” The Commissioner also highlights that PRIME optimises the use of the current regulatory framework that can contribute to the European Commission’s priorities in terms of boosting innovation, jobs, growth and competitiveness.

“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,” explains Professor Guido Rasi, EMA’s Executive Director. “Patients with no or insufficient treatments could then benefit from scientific progress and cutting edge medicines as soon as possible.”…