The PRIME programme was launched by the EMA in 2016 to provide early and enhanced support to optimize the development of eligible medicines, speed up their evaluation, and contribute to timely patient access. To be eligible for PRIME, medicines must address an unmet medical need and preliminary data must be available showing the potential to address this need and bring a major therapeutic advantage to patients.
Objective of PRIME designation:
PRIME is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier.
PRIME builds on the existing regulatory framework and tools already available such as scientific advice and accelerated assessment. This means that developers of a medicine that benefitted from PRIME can expect to be eligible for accelerated assessment at the time of application for a marketing authorisation.
Fostering early dialogue
By engaging with medicine developers early on, PRIME is aimed at improving clinical trial designs so that the data generated is suitable for evaluating a marketing-authorisation application.
Key benefits for applicants
Once a candidate medicine has been selected for PRIME, the Agency will:
- appoint a rapporteur from the Committee for Medicinal Products for Human Use(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, so that they provide guidance on the overall development plan and regulatory strategy;
- assign a dedicated contact point;
- provide scientific advice at key development milestones, involving additional stakeholders such as health-technology-assessment bodies, to facilitate quicker access for patients to the new medicine;
- confirm potential for accelerated assessment at the time of an application for marketing authorisation.
The scheme focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options. These medicines are considered priority medicines by EMA.
To be accepted for PRIME, a medicine has to show its potential to benefit patients with unmet medical needs based on early clinical data.