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EMA launches PRIME scheme

Published on 08/03/16 at 08:58am

The European Medicines Agency (EMA) has launched its new PRIME (priority medicines) scheme, which aims to strengthen support to medicines that target an unmet medical need.

It will seek to focus on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients with no treatment options.

The EMA will use PRIME to optimise the generation of robust data on a medicine’s benefits and risks and enable accelerated assessment of new drugs through early, proactive and enhanced support to manufacturers.

EMA says this will help patients benefit as early as possible from therapies that may significantly improve their quality of life.

Vytenis Andriukaitis, EU commissioner for Health and Food Safety, comments: “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.

“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.”

Professor Guido Rasi, executive director of the EMA, explains: “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. Patients with no or insufficient treatments could then benefit from scientific progress and cutting-edge medicines as soon as possible.”

Dr Thomas Salmonson, chair of the Committee for Medicinal Products for Human Use, adds: “We want to ensure that breakthroughs in medicines reach patients quicker. By strengthening collaboration between the scientific committees, and by gaining and sharing knowledge on the medicine throughout the development, we will not only accelerate patients’ access but also ensure an efficient use of available resources.”

The EMA also detailed the process whereby a medicine can achieve this accelerated assessment for marketing authorisation once the drug has shown its potential to benefit patients with unmet medical needs based on early clinical data. Once a candidate medicine has been selected for PRIME, the agency appoints a rapporteur from EMA’s Committee for Medicinal Products for Human Use (CHMP) to provide continuous support and help to build knowledge ahead of a marketing authorisation application. The Agency organises a ‘kick-off’ meeting with the rapporteur and a multidisciplinary group of experts from relevant bodies to provide guidance on the overall development plan and regulatory strategy; assigns a dedicated EMA contact point; and provides scientific advice at key development milestones, involving additional stakeholders such as health technology assessment bodies to facilitate patients’ quicker access to the new medicine.

Sean Murray

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