A Comparative Review of Fast-Track Generic Drug approvals: Criteria and Timelines across FDA, Swissmedic, MHRA, and PMDA
Abstract
Accelerated approval pathways for generic medicines improve patient access and reduce healthcare costs by speeding market entry without compromising quality. The U.S., Switzerland, the U.K., and Japan have developed distinct mechanisms to prioritize generic application reviews amid evolving regulatory frameworks. This review compares fast-track approval criteria, review timelines, documentation requirements, and reliance or harmonization efforts across the FDA, Swissmedic, MHRA, and PMDA. A systematic literature search from January 2000 to June 2025 included peer-reviewed articles and official guidance. Data on review timelines, eligibility criteria, dossier requirements, and reliance agreements were extracted using a standardized template. Comparative tabulation identified similarities and differences. The FDA’s Priority Review targets an eight-month approval for eligible ANDAs, supported by GDUFA performance goals. Swissmedic’s accelerated assessment shortens review from 330 to 150 days, enabled by pre-application hearings and the Access Consortium. MHRA offers 60- and 110-day tracks through the International Recognition Procedure by accepting reference regulators’ decisions. PMDA prioritizes generics within a nine-month timeline, supplemented by pre-submission consultations and "Harmonization by Doing" initiatives. All agencies require bioequivalence via ICH CTD modules but differ in clock-stop policies, administrative demands, and reliance frameworks.
Conclusion: While agencies align on bioequivalence and dossier formats, differences in timelines, review mechanisms, and dossier requirements challenge submission planning. Standardizing performance goals, reducing administrative burdens, and harmonizing reliance agreements are emerging good practices supporting faster global access to generic drugs.
Keywords:
Fast-track approval, Generic drug regulation, Abbreviated New Drug Application, Bioequivalence, FDA regulatory pathways, Swissmedic accelerated assessment, MHRA International Recognition Procedure, PMDA Priority Review, Regulatory harmonisation, Expedited generic drug approval
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Deshmukh SN, Ali SS, Shirole SA. A Comparative Review of Fast-Track Generic Drug approvals: Criteria and Timelines across FDA, Swissmedic, MHRA, and PMDA. Int J Drug Reg Affairs [Internet]. 2025Dec.15 [cited 2026Jan.31];13(4):1-18. Available from: https://www.ijdra.com/index.php/journal/article/view/794
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