Irene Cabani -

Similar to FDA’s Breakthrough Therapy designation, through the PRIME (PRIorityMEdicines) scheme, the European Agency (EMA) 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 in EU.

Key PRIME benefits for applicants are 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 days to 150 days).

The European Medicines Agency (EMA) in March this year published the 5-year report on the PRIME scheme, which provides a detailed analysis and review of the Agency’s experience with the scheme?in its first 5?years of application.

From this report it comes out that 33% of the PRIME applications were switched to standard timetable due to major CMC objections, in particular for Advanced Therapy Medicinal Products (ATMP).

To prevent CMC objections an early and continuous dialogue with regulatory authorities including scientific advices with different regulatory agencies, as well as a timely dialogue on GMP matters and the staggered provisions of data as post approval commitments are suggested.

Regulatory Pharma Net (RPN) can fully support to optimize drug development strategies including assistance in dialogue procedures such as Scientific Advice and PRIME procedures

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