This new program, named PRIME (PRIority
MEdicines) Scheme was designed to reinforce early dialogue between all
stakeholders, stimulate innovation, optimize development and enable accelerated
assessment of medicines.
The scope of this project is aimed at medicines
with a high public health potential and unmet medical needs and the
objective is to optimize the existing European regulatory tools, in order to
better use them at the most critical milestones.
Through PRIME, it will be possible to identify
products meeting the criteria for accelerated review at earlier stages, thus
enhancing the regulatory and scientific support to these products through
advice on key milestones during development. These will also contribute to the
reinforcement of predictability of EU regulatory system.
The support provided under this program will
include:
- Tailored
support to the stage of development of the product - Early
CHMP Rapporteur appointment – continuity throughout development and lifecycle
phases - Kick
off meeting with participation of Rapporteur and different experts from the
Agency’s Committees to discuss development options and regulatory strategy - Iterative
Scientific Advice at major development milestones - Fee
incentives for SMEs
PRIME Scheme was developed for products which
undergo accelerated assessment, therefore eligibility criteria will comprehend
not only those of the accelerated assessment but also availability of adequate
non-clinical and exploratory clinical data, justifying a major public health
interest and the potential to address an unmet medical need.
The evaluation of PRIME requests will be
carried out by the Scientific Advice Working Party, together with the CHMP.
The European Medicines Agency will prioritize
this project, allocating the necessary resources to evaluate and follow-up on
the upcoming proposals in 2016.
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