Spring Intro 2023

30/03/2023

PRIME PRIority MEdicines

EMA will • appoint Rapporteur early to provide continuous support • organise initial meetings with rapporteurs and scientific committees • issue guidance on proposed development plan and strategy • provide a dedicated EMA contact person • provide scientific advice at key development milestones

Special support for SMEs and academia • can apply at an earlier stage with less supporting data • fee waivers

Developers of a medicine that benefitted from PRIME can expect to be eligible for accelerated assessment at the time of application for a marketing authorisation.

https://www.ema.europa.eu/en/human-regulatory/research-development/prime-priority-medicines

The Organisation for Professionals in Regulatory Affairs

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US Fast Track & Breakthrough

Program

Criteria

When to Submit

Features/Considerations

Serious condition AND addresses unmet medical need, OR

With IND or after

Easier access to meetings with FDA review team throughout the drug’s development

•

•

Ideally, no later than the pre-BLA/pre-NDA meeting

Fast Track

Qualified as infectious disease product (QIDP)

Rolling review

•

•

(designation)

Designation may be withdrawn by the Agency if criteria are no longer met

•

A drug that is intended, either alone or in combination, to treat a serious, life-threatening disease or condition Preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints

Submit after IND (ideally, no later than end-of-Phase 2 meeting)

All of the above

•

•

Intensive guidance on an efficient drug development program, beginning as early as Phase 1 Collaborative, Cross-discipline review with senior managers and experienced review staff

•

Breakthrough Therapy

•

•

(designation)

FDA Project Lead assigned to facilitate efficient review

•

The Organisation for Professionals in Regulatory Affairs

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