Amid the restructuring of global supply chains and escalating geopolitical tensions, pharmaceuticals have come to be regarded as strategic national-security assets. Chih-Kang Chiang (姜至剛), Director General of the Taiwan Food and Drug Administration (TFDA), argues that “health sovereignty” involves more than ensuring supplies of medicines and medical supplies during a crisis. More fundamentally, it requires a science-based, resilient, and trustworthy system of pharmaceutical regulation and governance.
In recent years, the TFDA has adopted a regulatory-reliance approach, drawing on review reports issued by authorities including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Japan’s Ministry of Health, Labour and Welfare (MHLW). This approach has shortened the review period for certain new drugs from 360 days to between 120 and 180 days. The TFDA has also introduced expedited pathways such as priority review, accelerated review, and conditional approval for regenerative medicinal products. Chiang stresses, however, that it is the process that has been accelerated; the standards have not been relaxed. Post-market risk management and active surveillance therefore remain necessary to continuously monitor the safety and efficacy of medicines in Asian populations.
The TFDA is responsible for the quality, efficacy, and safety of medicines, while drug pricing, National Health Insurance (NHI) reimbursement, and the associated financial burden are the responsibility of the National Health Insurance Administration (NHIA). Under the existing parallel review mechanism, the marketing authorization review and health technology assessment (HTA) can proceed simultaneously, shortening the time between obtaining marketing authorization and securing NHI reimbursement.
The TFDA has also streamlined the review of multinational, multicenter clinical trials, established a fast-track review mechanism for regenerative medicine, released standardized Institutional Review Board (IRB) document templates, and made English-language review reports publicly available. These measures are intended to improve the transparency and predictability of the regulatory environment and encourage international pharmaceutical companies to conduct early-stage clinical trials in Taiwan. Nevertheless, market size, drug-pricing considerations, and political and diplomatic factors may still influence pharmaceutical companies’ strategic decisions.
To strengthen national pharmaceutical resilience, the government is promoting the domestic research, development, and production of critical medicines and medical devices. The TFDA and the Ministry of Economic Affairs are responsible for advancing the goal of having medicines “made in Taiwan,” while the NHIA promotes their clinical use and reimbursement so that domestically produced medicines are also “used in Taiwan.” According to Chiang, Taiwan’s research and development capabilities are becoming increasingly innovation-driven, although its present strengths still lie in turning plans into practice and carrying them through. The ultimate goal of health sovereignty is to make Taiwan an indispensable and trusted hub in the global pharmaceutical supply chain.
【2026-09-18/The News Lens】
