Taiwan’s population of just 23 million people and contested political status should, in theory, harm its chances of becoming a globally relevant clinical trials hub. In fact, these two factors – which have forced the island to adopt the most rigorous international standards and build a dense web of global partnerships – might ultimately be its saving graces.
Speed, Standards, Global Reach
While Taiwan is best known internationally for its semiconductor industry, its less-heralded healthcare sector has also become globally competitive, as has its offering to clinical trial sponsors.
“Our clinical research infrastructure is genuinely world-class, underpinned by an outstanding talent pool,” lays out Yenchen Huang, head of investment and vice president at local venture capital firm Diamond Biofund. “Taiwan’s brightest students overwhelmingly attend medical school, creating exceptional depth of clinical talent, and our healthcare system achieves global standards,” he adds.
And things are only getting better. “Several recent developments have strengthened Taiwan’s position in the global clinical trial landscape,” notes Samuel Su, CEO and founder at Taiwanese-headquartered contract research organisation (CRO) Bestat Pharmaservices.
“These include accelerated regulatory review mechanisms introduced by the Taiwan FDA, the establishment of the Taiwan Alliance of Clinical Trial Centers to better coordinate research activities, and sustained policy support from the government for the biotechnology and pharmaceutical sectors.”
Approvals times are down too – Taiwan FDA’s standard IND review takes around 45 calendar days – making Taiwan an increasingly attractive trial location. “The most significant recent regulatory update has been to the MRCT review mechanism,” says Tina Sun, president of the Taiwan Clinical Research Association (TCRA), which brings together the island’s network of CROs.
“If your clinical trial is conducted in Taiwan and simultaneously in one of ten reference countries, you qualify for the MRCT pathway,” she continues. “This expedited process eliminates the comprehensive scientific review typically conducted within the Taiwan FDA and can compress approval timelines to approximately two weeks, with optimal cases achieving approval within ten days.”
Additionally, the Taiwanese authorities have not been shy about positioning themselves at the forefront of emerging trends in the space. “Over the past two decades, we have developed regulations paralleling international best practices,” says Sun.
“A particularly instructive example of the authorities’ foresightedness occurred during the COVID-19 pandemic,” she continues. “When Denmark published the first decentralised clinical trial guidance, the Taiwan FDA immediately prepared a Traditional Chinese-language version. By 2023, Taiwan became the first Asian nation to publish comprehensive DCT guidance.”
The quality of Taiwan’s investigator community “more than compensates” for the island’s small population, adds Susan Hsu, CEO of another local CRO, StatPlus. “In oncology specifically [which accounted for almost half of Taiwan’s IND applications in 2024 – ed.], and particularly in lung cancer, Taiwan’s investigators are world-class and the recruitment rates are among the highest globally,” she adds. Many of these trials are in newer, advanced treatment modalities: Taiwan has logged 46 gene therapy and 103 cell therapy IND submissions to date.
All of this is leading to Taiwan’s inclusion in a wider swathe of international studies in these fields, says Hsu, who also points out that Taiwan’s databases and patient registries make it a “natural starting point” for sponsors attempting to get to grips with the regional patient landscape in rare diseases.
Those resources are substantial: the Taiwan Biobank now holds data on more than 200,000 participants, underpinned by a National Health Insurance system with 99.9 percent population coverage.
Taiwan’s diminutive size has also forced its local biotech ecosystem to be global from the get-go, combining Taiwanese and international trials early. “Taiwan offers a strong base, given the quality of investigators and our close relationships with key opinion leaders, and it is often the most efficient place to begin a study,” says Hong-Ren Wang, president and CEO of local clinical-stage oncology biotech PharmaEngine.
“However, no programme with global ambitions can rely solely on Taiwanese data,” admits Wang. “We involve Australian sites early to incorporate Caucasian populations, and as the evidence matures, we extend our trials into the United States and Europe. This progression is essential, as no oncology drug can recover its development investment through a single domestic market.”
Taiwan has held full International Council for Harmonisation (ICH) membership since 2018 – one of the first in Asia to achieve full membership – meaning data generated on the island can be used to support regulatory applications to the FDA, EMA, and NMPA and therefore access to the US, European, and Chinese markets respectively.
Hsu continues, “The overall hospital infrastructure is genuinely friendly to clinical trial activity, and international companies consistently find Taiwan a straightforward and reliable environment in which to work.”
Kris Hager, general manager for Taiwan at one such international company – US giant Bristol Myers Squibb – backs her up. “The clinical trial environment in Taiwan is highly mature,” says Hager, whose company is running multiple clinical trials in Taiwan, including for some of its CAR-T cell therapy pipeline. “Hospitals, investigators, and study leads consistently deliver high-quality execution and strong protocol adherence,” he adds.
Danish obesity and diabetes powerhouse Novo Nordisk is another firm taking advantage of what Taiwan General Manager Hans Duijf calls “high clinical standards and competitive costs.” Duijf does, however, caution that Taiwan could benefit from “continuing to streamline the administrative and approval process for clinical trials. The current experience can involve navigating multiple review and approval steps sequentially, which adds time and complexity.”
Bestat’s Su agrees, adding that “there is still room for improvement within Taiwan’s ecosystem, particularly in better integrating clinical trial resources across hospitals, developing more professionals with global clinical development experience, and strengthening collaboration among the many smaller organisations that make up the country’s biotech sector.”
Momentum Building
Nevertheless, the vibe among the stakeholders of the Taiwanese clinical trial ecosystem is overwhelmingly positive, especially since a challenging couple of years for global biotech funding between 2023 and 2024 seem to be in the rear-view mirror.
“Global studies are returning to Taiwan, new projects are being initiated, and we have also taken on some studies that were transferred to us from other providers,” says Hsu of StatPlus. “The recovery feels real and it feels sustained.”
TCRA’s Sun has also observed “renewed momentum,” noting a willingness across the board to speed up and improve the clinical trial process. “Clinical trial centres have demonstrated heightened eagerness to improve performance metrics,” she says. “Through our collaboration with the Taiwan Institutional Review Board (IRB) Association, we have identified specific pain points requiring resolution and are collectively committed to accelerating start-up processes.”
Local firms could be set to play a larger role in this resurgence, many of them reaping the rewards of the semiconductor boom, suggests Diamond Biofund’s Huang. “Taiwan’s dominant semiconductors and electronics industries are now seeking their next billion-dollar growth opportunities in healthcare,” he posits. “The top ten electronics companies have established healthcare business units, attempting to leverage their core competencies.”
All in all, this is a unique and differentiated clinical trials hub, where potential weaknesses are being repurposed as strengths. “Taiwan’s unique geopolitical circumstances – persistent political tensions and our historical struggle for international recognition – have fostered a collaborative mindset where collective action generates substantial impact,” concludes Sun.
