The European Medicines Agency (EMA) has launched 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, the EMA offers early, proactive and enhanced support to medicine developers to optimize 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, PRIME aims to strengthen clinical trial designs to facilitate the generation of high quality data for the evaluation of an application for marketing authorization. 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 authorization, and help to make best use of limited resources.
PRIME builds on the existing regulatory framework and available tools such as scientific advice and accelerated assessment. This means that a PRIME medicine is expected to benefit from accelerated assessment at the time of an application for marketing authorization.
EMA has released guidance documents on PRIME as well as a comprehensive overview of the EU early access regulatory tools, i.e. accelerated assessment, conditional marketing authorization and compassionate use. Revised guidelines on the implementation of accelerated assessment and conditional marketing authorization are also published. All these tools are reserved for medicines addressing major public health needs. The revised guidelines provide more detailed information based on past experience. They encourage early dialogue between the various stakeholders which is crucial to optimize use of these tools. Although PRIME is specifically designed to promote accelerated assessment, it will also help to make best use of other EU early access tools and initiatives, which can be combined whenever a medicine fulfills the respective criteria.
PRIME was developed in consultation with the agency's scientific committees, the European Commission, and its expert group on Safe and Timely Access to Medicines for Patients (STAMP) as well as the European medicines regulatory network. The main principles of PRIME were released for a two-month public consultation in 2015 and the comments received were taken into account in the final version.
Source: European Medicines Agency