EMA launches priority medicines scheme

The European Medicines Agency's (EMA) new PRIME (PRIority MEdicines) scheme aims to 'strengthen support to medicines that target an unmet medical need'.

Through PRIME, EMA offers early 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'.

By engaging with medicine developers early, the scheme aims to strengthen clinical trial designs to facilitate the generation of high quality data for the evaluation of an application for marketing authorisation.

'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,' said 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.'

To be accepted for PRIME, a medicine has to show 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 will:

• appoint a rapporteur from EMA’s CHMP or from the Committee on Advanced Therapies (CAT) in the case of an advanced therapy, to provide continuous support and help to build knowledge ahead of a marketing authorisation application;
• organise a kick-off meeting with the CHMP/CAT rapporteur and a multidisciplinary group of experts from relevant EMA scientific committees and working parties, and provides guidance on the overall development plan and regulatory strategy;
• assign a dedicated EMA contact point;
• provide scientific advice at key development milestones, involving additional stakeholders such as health technology assessment bodies to facilitate patients’ quicker access to the new medicine;
• confirm potential for accelerated assessment at the time of an application for marketing authorisation.

While PRIME is open to all companies on the basis of preliminary clinical evidence, micro-, small- and medium-sized enterprises (SMEs) and applicants from the academic sector can apply earlier on the basis of compelling non-clinical data and tolerability data from initial clinical trials. They may also request fee waivers for scientific advice.

'Since SMEs and academia often lack experience with the regulatory framework, they can benefit in particular from earlier scientific and regulatory advice,' the Agency said.

EMA has released guidance documents on PRIME as well as a comprehensive overview of the EU early access regulatory tools.

Revised guidelines on the implementation of accelerated assessment and conditional marketing authorisation have also been published. All of these tools are reserved for medicines addressing major public health needs.

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