European Medicines Agency Proposes PRIME Priority Drug Scheme

The European Medicines Agency announced a new drug pathway program that promises earlier, more extensive support for drugmakers researching new priority therapies to increase chances of taking them to market.

Called PRIME, the program allows for shorter review times to provide earlier patient access to new medicines.

To qualify, drugmakers must meet standards for accelerated assessment and have a candidate that would provide significant efficacy benefits over current treatments.

Companies are encouraged to focus on the most pressing, transformative medical innovations and the most urgent patient populations.

Selected researchers will be given hands-on guidance throughout the process via an early designation by an EMA Committee for Medicinal Products for Human Use rapporteur who will coordinate the plan.

Scientific advice will be offered from the earliest phases to a preliminary meeting with key experts, outlining regulatory requirements and an advice schedule, and through drug development milestones. The efforts will include discussions of specific data, risk-benefit profiles, trial design, next steps and early access possibilities, especially accelerated assessment which most PRIME candidates will likely fall into.

The proposed scheme would go into effect in early 2016. Comments are due by Dec. 23.

Full details about PRIME can be read at fdanews.com/EMA-PRIME-2015.pdf. — Victoria Pelham

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