PRIME (PRIority MEdicines) scheme

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Quality & Compliance

EMA SCHEME FOR PRIORITY MEDICINES

Through the PRIME (PRIority MEdicines) scheme, the European Agency (EMA) offers early and proactive 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 in EU.

PRIME BENEFITS

Key PRIME benefits for applicants include:

Guidance on the overall development plan and regulatory strategy.
Scientific advice at key development milestones, involving additional stakeholders such as health-technology-assessment bodies.
Eligibility for accelerated assessment (which reduces the assessment timeframe from 210 to 150 days).

RPN supports companies in the PRIME eligibility request and subsequent scientific advice.