Taiwan’s population is over 23.42 million (2024),2 concentrated in six major metropolitan areas. The high level of urbanisation and convenient transportation facilitates recruitment and follow up of study participants. With its aging population, Taiwan provides access to a wide range of participants in different therapeutic areas.
The top five causes of death in Taiwan include6:
The wide range of common diseases supports diverse research areas, including oncology, neurology, respiratory disease, endocrinology and cardiovascular diseases (Chart 2).3
Number of IND Applications by Year (2014-2024)3 |
Percentage of IND Applications By Therapeutic Area, 20243 |
Taiwan is a growing market for Investigational Manufactured Products development and an attractive location for pharmaceutical, biotech and medical device companies. Additionally, the National Health Insurance (NHI) program provides universal healthcare access that benefits both patients and researchers.2
Approximately 47% of Investigational New Drug (IND) Applications submitted in 2024 were oncology trials.3 Taiwan has a strong cancer control infrastructure, including a population-based cancer registry4 and National Cancer Control Programs,5 and is engaged in research that helps quickly identify eligible participants for oncology trials.
The ten most common cancers by number of new cases in 2021 are2,4:
The well-established oncology treatment system offers advanced technology, comprehensive care, and good outcomes. In 2024, 99.9% of cancer diagnosis and treatment were covered by the NHI.2 Additionally, Taiwan offers a wide range of treatment modalities, including surgery, chemotherapy, targeted therapy, immunotherapy, and various radiotherapies like proton therapy1 and gamma knife radiosurgery.6
Taiwan is an active participant in CAR-T cell therapy clinical trials. From 2020-24, the National Taiwan University Hospital has conducted a total of 141 CAR-T trials in collaboration with 5 biotech and pharmaceutical companies worldwide, comprising 131 preclinical studies, 8 Phase I/II trials, and 2 Phase III trials.6
The experienced sites with CAR-T clinical trials in Taiwan include:
The standard review process for an initial clinical trial (IND) application by Taiwan’s Food and Drug Administration (TFDA) takes approximately 45 calendar days.7 The fast-track review available under the Multinational Clinical Trial Notification Scheme (CTN) reduces review time to 14 days if the protocol is simultaneously submitted to a notable regulatory authority (e.g., FDA or EMEA). CTNs now account for 30% IND trials.8
TFDA has also improved transparency and efficiency in clinical trial approvals by measures including:
The IRB submission can be done in parallel with the IND. The central-IRB has 10 main-review IRBs (20 working days for approval) and 40 approved sub-review IRBs (20 working days for review post-central IRB review).10 This system is applicable for multicentre trial(s) that includes at least one site to be one of the main c-IRB review members.
There are 412 qualified medical institutions and 142 qualified clinical trials sites by TFDA in Taiwan (May 2025).3,11
The government actively collaborates with industry and academia to promote the development process (Table 2).
Taiwan Clinical Trial Consortium (TCTC) | TaiwanClinicalTrials.tw6 | Taiwan Principal Investigator Database (TPIDB)12 |
The TCTC was funded by the Taiwan MOHW, bringing together 14 disease-specific consortiums involving 300+ experienced principal investigators and medical professionals. | The Taiwan Clinical Trials website provides up-to-date comprehensive clinical trial information, including regulatory information, health statistics, and clinical trial centres. | The TPIDB is a public resource that contains information on clinical trials approved by the TFDA, combining 2,000+ PIs, 5,000 MDs and operation site data. |
The government has adopted regulatory measures on medical education and training. There were 23 medical specialties, and 59,863 physicians who received their medical specialty licenses by December 2023.3
All experts conducting clinical trials must receive relevant training of more than 30 hours within the past 6 years and if conducting Human Trials of somatic cells or gene therapy, then 5+ additional hours are required.13
The Cross-strait Medicine and Health Cooperation Framework Agreement between Taiwan and China (2010) facilitates the exchange of information in healthcare and clinical research. This has accelerated drug approval process allowing more drugs developed in Taiwan to enter China early.
Four Taiwanese clinical trial are recognised by China:
With its advanced infrastructure, efficient regulations, and diverse patient population, Taiwan offers an ideal setting for high-quality clinical trials. In this thriving environment, Precision for Medicine is well-positioned to deliver exceptional value.
Through its registered legal entity in Taiwan, Precision for Medicine is staffed by experienced clinical research and regulatory professionals who provide end-to-end support for clients’ clinical trials.