A New Horizon:

Strategic Clinical

Development in Taiwan

Taiwan is a major hub for clinical trials in the Asia-Pacific region, known for its high-quality medical infrastructure, supportive government policies and experienced personnel. As a top destination for multinational clinical trials, Taiwan offers a favourable environment for global sponsors seeking to accelerate drug development.

Key Strengths of the Taiwan Clinical Trial Sector

Efficient regulatory environment: Taiwan's regulatory framework is harmonised with international standards from the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The Taiwan Food and Drug Administration (TFDA) and Center for Drug Evaluation (CDE) have created streamlined processes to expedite trial approvals.

The standard review process for an initial clinical trial (IND) application by Taiwan’s Food and Drug Administration (TFDA) takes approximately 45 calendar days. 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., U.S. FDA or the European Medicines Agency (EMA). CTNs now account for 30% IND trials.
A centralized Institutional Review Board (c-IRB) system also helps speed up multicenter trial reviews, with many submissions receiving a decision within 20 working days.

Diverse Patient Population and Genetics: Taiwan’s diverse population, in terms of ethnicity and genetics, can be beneficial for studies that require a broad representation of the global population.

Strategic therapeutic focus: Due to its demographic profile, Taiwan has a large patient pool for prevalent diseases like cancer, hepatitis B and diabetes. This has led to a major focus on oncology, with nearly half of all Investigational New Drug (IND) applications in 2024 related to cancer.

Government support: The Taiwanese government actively supports the biomedical sector as a strategic industry through various initiatives and incentives.

This includes the Act for the Development of Biotech and New Pharmaceuticals Industry and the "5+2 Innovative Industries Plan," which aim to significantly grow the biotech economy.
Government funding and tax incentives for biotech research and development have helped attract increased investment.

Key Institutions and Organisations

Taiwan Clinical Trial Consortium (TCTC): This network brings together disease-specific consortiums and experienced medical staff to coordinate clinical trials and promote excellence in the field.

Academic and medical centers: Numerous world-class medical institutions participate in clinical research. Notable examples include:

National Taiwan University Hospital (NTUH)
Chang Gung Memorial Hospital
China Medical University Hospital (CMUH)
Taipei Veterans General Hospital

Contract Research Organizations (CROs): Both global and regional CROs operate in Taiwan, providing essential services for trial sponsors. Examples include global players like IQVIA and Parexel, as well as Asia-Pacific specialists like Novotech.

Center for Drug Evaluation (CDE): The CDE assists the TFDA with the technical review of clinical trial applications for new drugs and medical devices.

Opportunities and Outlook

Taiwan's position as a clinical trial hub is set to grow stronger due to several factors:

Regional expansion: Taiwan's strategic location provides a gateway to other major markets in the Asia-Pacific region, such as China, Japan and South Korea, which is an advantage for multi-regional trials.

Technological innovation: The country's expertise in technology and data analytics is being integrated into the clinical trial process to enhance efficiency and data quality.

Biotech investment: Continued government and private investment in the biotech sector is accelerating R&D and attracting international collaboration.

Cell therapy research: Taiwan is pioneering research in cellular therapies, with several academic centers certified for advanced treatments and a growing number of CAR-T cell trials underway. From 2020-2024, 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.

Join us at Biologics World Taiwan (BWT) 2026, taking place on 25–26 March 2026 in Taiwan, to discover the latest trends and partnerships driving the future of biologics and clinical research.

Whether you represent a biopharma company, clinical research organisation or technology enabler, BWT 2026 is the platform to connect with industry leaders and decision-makers shaping Asia’s biopharma landscape.

We look forward to welcoming you to BWT 2026.

VISIT OUR WEBSITE