pISSN 1226-6051
eISSN 2508-786X
eISSN 2508-786X
Expedite programs that provide intensive regulatory guidance for innovative drug development and approval in the United States, the European Union, and the Republic of Korea
| FDA | EMA | MFDS | ||
|---|---|---|---|---|
| Program | Fast Track | Breakthrough Therapy | PRIME | Accelerated Examination |
| Features/ Benefits | • Actions to expedite development and review | • All Fast Track designation features | • Early appointment of and initial kick-off meeting with a CHMP/CAT Rapporteur | • Intensive guidance on the program and data preparation |
| • Rolling review | • Intensive guidance on an efficient drug development, beginning as early as Phase 1 | • Assigning an dedicated contact point of EMA | • Iterative scientific advice over the entire development pathway | |
| • Organizational commitment involving senior managers | • Iterative scientific advice on the overall development plan | • Approved based on the data collected up to therapeutic exploratory study | ||
| • Dedicated toolbox for quality data package development | • Approvable based on a surrogate or an intermediate endpoint | |||
| Qualifying criteria | • Drug products intended to treat a serious condition AND nonclinical or clinical data demonstrating the potential to address unmet medical need | • Drug product intended to treat a serious condition | • Medicinal product for target conditions with an unmet medical need | • Drug intended to treat a serious condition without effective therapy or to do with improved effectiveness |
| • OR designated as a qualified infectious disease product | • AND preliminary clinical evidence demonstrating substantial improvement on a clinically significant endpoint(s) over available therapies | • Demonstrating the potential to address the unmet medical need | • Or orphan drug | |
| • Available data supporting the potential for a major therapeutic advantage to patients | • Or innovative biotherapeutic for bioterrorism or pandemic infectious disease | |||
| Time of request | • With IND or after | • With IND or after | • At gaining compelling non-clinical data in a relevant model with early evidence of promising activity (proof of principle) | • At gaining preliminary clinical data that confirm clinically meaningful efficacy from target disease. |
| • Ideally, no later than the pre-BLA or pre-NDA meeting | • Ideally, no later than the end-of-phase 2 meeting | • And completing first-in-human studies indicating adequate exposure for the desired pharmacotherapeutic effects and tolerability | ||
| Guidelines | • Expedited Programs for Serious Conditions - Drugs and Biologics (2014) | • EMA Guidance for applicants seeking access to PRIME scheme (2023) | • Guideline on the application criteria for the fast track review of pharmaceuticals (2021) | |
| • Expedited Programs for Regenerative Medicine Therapies for Serious Conditions (2019) | ||||
BLA, Biologics License Applications; EMA, European Medicines Agency; FDA, Food and Drug Administration; IND, Investigational New Drug; MFDS, Ministry of Food and Drug Safety; PRIME, PRIority MEdicines; NDA, New Drug Application