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.
Through PRIME, the Agency offers early and proactive support to medicine developers to optimise the generation of robust data on a medicine’s benefits and risks and enable accelerated assessment of medicines applications.
This will help patients to benefit as early as possible from therapies that may significantly improve their quality of life.
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.
Early dialogue and scientific advice also ensure that patients only participate in trials designed to provide the data necessary for an application, making the best use of limited resources.
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.
Earlier support for small businesses and researchers
While PRIME is open to all companies on the basis of preliminary clinical evidence, applicants from the academic sector and micro-, small- and medium-sized enterprises (SMEs) can apply earlier on the basis of compelling non-clinical data and tolerability data from initial clinical trials.
SMEs and academia generally have less experience with the regulatory framework and therefore would benefit from earlier scientific and regulatory advice.
They may also request fee waivers for scientific advice.
How to apply
Eligibility requests for PRIME should be submitted via Eudralink to firstname.lastname@example.org, using:
- PRIME eligibility requests: deadlines for submission and timetable for assessment;
- Pre-submission request form - PRIME (select 'Human medicinal products', then ‘Eligibility’ and ‘PRIME’);
- Applicant's justification template to provide evidence supporting the request.
When preparing their request, applicants should refer to:
- Enhanced early dialogue to facilitate accelerated assessment of PRIority MEdicines (PRIME);
- Guidance for applicants seeking access to PRIME scheme.
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.
A draft reflection paper was published for public consultation between October and December 2015.
- Draft reflection paper on a proposal to enhance early dialogue to facilitate accelerated assessment of priority medicines (PRIME)
- Overview of comments received on the reflection paper (comments are listed by the number assigned to each stakeholder)
- Summary of comments received during the public consultation
- List of stakeholders
The final document 'Enhanced early dialogue to facilitate accelerated assessment of PRIority MEdicines (PRIME)' was adopted by the CHMP during its February 2016 meeting.
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Press briefing - presentations
- Enhanced early dialogue to facilitate accelerated assessment of PRIority MEdicines (PRIME) (07/03/2016)
- European Medicines Agency guidance for applicants seeking access to PRIME scheme (07/03/2016)
- PRIME eligibility requests: deadlines for submission and timetable for assessment (07/03/2016)
- European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance (14/10/2014)