pISSN 1226-6051
eISSN 2508-786X

Table. 6.

Table. 6.

Expedite programs that shorten the review clock for innovative drug development and approval in the United States, the European Union, and the Republic of Korea

FDA EMA MFDS

Program Priority Review Accelerated Assessment Accelerated Examination
Features/ Benefits • Shorter clock for review of marketing application (6 months compared with the 10-month standard review) • MAA evaluation with reduced timeframe to 150 days from standard 210 days • NDA review with reduced timeframe to 90 days from standard 120 days
• Based on epidemiological data about the disease from published literature or registries. • NDA review prior to other medicinal products

Qualifying criteria • Treats a serious condition AND, if approved, providing a significant improvement in safety or effectiveness • Medicinal product of major public health interest from the viewpoint of therapeutic innovation. • Drug to treat a serious major disease or a rare disease
• OR proposing a labeling change pursuant to a report on a pediatric study under 505A • For prevention, diagnosis or treatment of conditions with unmet medical need • New drugs developed by an innovative pharmaceutical enterprise
• OR designated as a qualified infectious disease product • Addressing a major public health interest
• OR submitted with a priority review voucher

Time of request • At the submission of original BLA, NDA, or efficacy supplement • At least 2-3 months before submitting MAA • New drugs developed by an innovative pharmaceutical enterprise - at the submission of NDA
• Recommending to request a pre-submission meeting 6-7 months before submission • Other than the above - at gaining preliminary clinical data that confirm clinically meaningful efficacy from target disease

Guideline • Expedited Programs for Serious Conditions - Drugs and Biologics (2014) • Guideline on the scientific application and the practical arrangements necessary to implement the procedure for accelerated assessment pursuant to article 14(9) of regulation (EC) No 726/2004 (2016) • 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 Application; EMA, European Medicines Agency; FDA, Food and Drug Administration; MAA, Marketing Authorisation Application; MFDS, Ministry of Food and Drug Safety; NDA, New Drug Application

Korean J Clin Pharm 2024;34:39-61 https://doi.org/10.24304/kjcp.2024.34.1.39
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