Unmet medical need is a widely used term in drug development with no single universal definition. The concept is meant to help differentiate more pressing patient and societal health needs and support priorities within regulatory Agencies. In practice, as there is no universal definition justification, unmet medical need is applied on a case-by-case basis.
The EMA’s approach to unmet medical need (UMN) can feel like a moving target, with each pathway presenting distinct requirements:
- Conditional Marketing Authorization
- Accelerated Assessment
- Orphan Designation
Without clarity on how UMN is evaluated, even a promising product can face delays or missteps. Each pathway demands a tailored strategy to align with EMA expectations and move your program forward efficiently.
