P317: Comparative Analysis of Drug Facilitated Regulatory Pathways and Review Outcomes among the USFDA, EMA, and Taiwan FDA
Poster Presenter
BI-KAI HSU
Senior Project Manager
Center For Drug Evaluation, Taiwan Taiwan
Objectives
To evaluate the implementation outcomes of the Facilitated Regulatory Pathways (FRPs) on new active substance (NAS) approvals in Taiwan from 2020-2024, providing evidence-based insights to support global regulatory strategy and pathway selection for industry stakeholders.
Method
1. Data were extracted from Taiwan Food and Drug Administration (TFDA) and Center for Drug Evaluation (CDE) databases, as well as Centre for Innovation in Regulatory Science (CIRS) annual reports.
2. Applications for the same active substance with different dosage strengths were analyzed as a single entry.
Results
TFDA has established five FRPs to expedite new drug approvals for unmet medical needs or serious life-threatening conditions. The review timelines for FRPs are 240 days including Priority Review (PR), Accelerated Approval (AA), Breakthrough Therapy Designation (BTD), and Pediatric and Rare Severe Disease Priority Review (PRSDPR); 180 days for Abbreviated Review (AR) Type I and 120 days for AR Type II.
To evaluate the outcome of FRPs on NAS approvals in Taiwan, data from 2020 to 2024 were analyzed. The results are summarized as follows:
1) Prior designation application is required for FRPs. The three major FRPs for designation were PR, PRSDPR, and AA. The designation approval rates of PR, PRSDPR, AA, AR and BTD were 62.5, 74.6, 78.6, 90.9 and 80.0%, respectively.
2) The annual proportion of FRPs for approved NAS was further analyzed. Most NAS approvals were reviewed under standard application (SA), while the three major FRPs were PR, PRSDPR and AA. The annual proportion of PRSDPR remained stable, while AA showed a slight increasing trend.
3) Review efficiency was assessed using median review times for approved NASs: 337 days for SA, 163 days for AR Type I, 91 days for AR Type II, 224 days for PR, 228 days for AA, 228 days for PRSDPR, and 224 days for BTD. Box plot analysis showed that the 75th percentile values adhered to the TFDA’s review timelines, with narrow interquartile ranges across FRPs. Follow-up analysis of approval outcomes showed approval rate of 95.4% for SA, 97.3% for PR, and higher rate of 100% for AR, AA, PRSDPR and BTD.
4) Comparative analysis of review timelines for approved NASs across different FRPs in the TFDA, United States Food and Drug Administration (US FDA), and European Medicines Agency (EMA) showed that US FDA generally achieved the shortest median calendar review times, whereas AA and BTD, the TFDA demonstrated shorter median calendar review times than the EMA.
Conclusion
Analysis of data from 2020 to 2024 demonstrates that TFDA’s review efficiency, consistency and predictability are broadly comparable to the EMA, while continuously aligning with the US FDA. These findings provide practical insights for global regulatory decision-making, informing the consideration of Taiwan in global submission strategies for industry stakeholders.
Recently, the TFDA has further proposed two new pilot programs shortening the review timeline to 100 days:
1. NDA Reliance Review Pilot Program: Targets non-orphan NAS approved by the US FDA, EMA, or Japan’s Ministry of Health, Labour and Welfare (MHLW), provided that bridging study is waived. Applications must be submitted within two years of reference authority's approval.
2. Accelerated Review for Domestic New Drugs Pilot Program: Applies to non-orphan NAS, biosimilars, and other designated essential drugs developed and manufactured in Taiwan. Applicants are required to adopt module-based rolling review prior to NDA submission.
Taken together, TFDA’s review outcomes and new pilot programs highlight the consistent policy refinement to enhance review efficiency, facilitate earlier market access to innovative medicines, and strengthen pharmaceutical supply chain resilience in Taiwan. As an International Council for Harmonisation (ICH) member, Taiwan FDA continues to establish a comprehensive, robust, and independent regulatory review framework harmonized with global regulatory standards, thereby supporting timely patient access and sustainable healthcare development.
