Chun-Yi Huang, Ling-Kuei Chen, Bi-Kai Hsu, Hwei-Fang Cheng, Chung-Hsuen Wu
The TFDA review timelines became substantially more predictable, and the pathway distribution shifted toward FRPs. These changes followed the 2017 and 2019 reforms and reflect their combined contribution rather than any single mechanism. The cross-agency figures reported here serve as a general point of reference rather than a direct efficiency comparison, given differences in product mix, therapeutic areas, pathway eligibility criteria, submission timing and clock-stop mechanisms. Building on these developments, the forthcoming reliance pilot program is expected to further support patient access and regulatory resilience.
BACKGROUND: Since 2011, the Taiwan Food and Drug Administration (TFDA) has established various facilitated regulatory pathways (FRPs, including expedited and accelerated review frameworks) for new drug applications. In 2017 and 2019, TFDA implemented the Refuse to File (RTF) mechanism and conducted a comprehensive revision of FRPs, respectively. This study aims to evaluate the outcomes of these reforms from 2015 to 2024, focusing on New Active Substance (NAS) approvals, pathway utilization, and international comparison.
METHODS: NAS approvals between 2015 and 2024 were analyzed using TFDA's internal regulatory database, with U.S. Food and Drug Administration (US FDA), European Medicines Agency (EMA), and Japan's Pharmaceuticals and Medical Devices Agency (Japan's PMDA) data obtained from public sources. Analyses and visualizations were conducted with R.
RESULTS: Following the 2017 and 2019 reforms, the on-time rate for the 360-day standard pathway surged from 19.0% of 21 cases in 2015 to 100% in 16 cases in 2024. A distinct structural shift toward FRPs was observed, as the proportion of standard applications declined from 80.4% to 56.4%. A contextual comparison of median approval times indicated that TFDA's timelines were broadly comparable to those of the EMA and moved closer to those of the US FDA and Japan's PMDA over the study period.
CONCLUSIONS: The TFDA review timelines became substantially more predictable, and the pathway distribution shifted toward FRPs. These changes followed the 2017 and 2019 reforms and reflect their combined contribution rather than any single mechanism. The cross-agency figures reported here serve as a general point of reference rather than a direct efficiency comparison, given differences in product mix, therapeutic areas, pathway eligibility criteria, submission timing and clock-stop mechanisms. Building on these developments, the forthcoming reliance pilot program is expected to further support patient access and regulatory resilience.