Taiwan possesses a high-quality healthcare system, professional medical talent, and comprehensive health data infrastructure, providing a strong foundation for clinical trial development. It is estimated that Taiwan has over a 60% chance of becoming one of the top 25% preferred global trial sites. However, clinical trial initiation remains constrained by complex administrative procedures and fragmented cross-ministerial reviews, limiting efficiency and affecting international collaboration as well as the timeline for new drug introduction.
The International Research-Based Pharmaceutical Manufacturers Association (IRPMA) released a white paper on the clinical trial ecosystem, highlighting that Taiwan’s challenge is not a lack of capability, but rather systemic and procedural bottlenecks. The report recommends establishing a cross-ministerial “one-stop clinical trial platform” to integrate review processes, patient recruitment, regulatory consultation, and resource matching, thereby accelerating trial initiation and strengthening global competitiveness.
Chairman Hu Yao-chung stated that, compared with countries such as Australia, South Korea, and Singapore, Taiwan still has room for improvement in regulatory and administrative integration. Shih Chung-Liang pointed out that Including Taiwanese participants in early-stage drug development could help address ethnic differences, reduce the need for additional regulatory submissions, and shorten the time from drug approval to clinical use.
Currently, the government has established the Taiwan Alliance of Clinical Trial Centers (TACTC) consisting of 31 hospitals. By integrating reviews and standardizing procedures, the government is streamlining trial implementation. In the future, incentives will be provided by linking drug licensing reviews with National Health Insurance (NHI) reimbursement mechanisms to further encourage clinical trials within Taiwan.
The white paper proposes a development framework of “One Platform, Four Capabilities, and Five Key Drivers,” aiming to increase clinical trial capacity by 2.5 times by 2035. It also identifies slow patient recruitment as a major bottleneck and suggests establishing a unified portal to improve matching efficiency.
In terms of economic impact, Taiwan's biotechnology services output was approximately NT$14.72 billion in 2024. If clinical trial capacity is increased, it could generate over NT$33 billion in new direct annual output, driving overall economic benefits to an estimated NT$50 billion.
The IRPMA emphasized that clinical trials are not only the foundation of medical innovation but also a vital key for Taiwan to integrate into the global biomedical value chain and develop precision medicine and digital health.
[2025-03-26/ Liberty Times]
