Clinical Trials in Taiwan – Opportunities and Regulatory Requirements – Part 1
Taiwan presents excellent opportunities for clinical trials, featuring advanced healthcare facilities, a diverse patient population, and strong recruitment rates, particularly for diseases like hepatitis B and diabetes.
The regulatory environment, governed by the Taiwan Food and Drug Administration (TFDA), is efficient and supportive, offering expedited reviews for innovative therapies. This combination of opportunities and a favorable regulatory framework makes Taiwan an attractive destination for both local and international clinical research.
This article was last updated in Oct 2024.
Taiwan has one of the most progressive healthcare systems in the world and is a major hub for clinical research in the Asia-Pacific region. Currently, it is well-positioned to meet the growing demands of the global clinical trial market. World-class, high-quality infrastructure, low cost, easy patient recruitment process due to dense populations are a few of the advantages for conducting clinical trials in Taiwan.
Top 5 reasons to choose Taiwan for your clinical trials?
There are many good reasons to go to Taiwan for clinical trials. Here are the top five of them
- The large talent pool of well-trained clinical practitioners
- State-of-the-art infrastructure
- Vast clinical trial experience
- Strategic location
- International ethical standards
Let’s discuss this in detail one by one
The large talent pool of well-trained clinical practitioners
Many investigators, internationally experienced, well-informed and trained, fluent in English – hard to ignore!
State-of-the-art infrastructure
Tens of well-established hospitals in such a small country speak volumes about their attention to improving infrastructure. These hospitals, some of which are associated with universities too, are well-equipped and carry out some of the best research in the world. There is strong government policy support for the development of a conducive environment for carrying out clinical trials.
Vast clinical trial experience
Plenty of trials have been performed in Taiwan and many more are ongoing. Have you been too late to go there?
Strategic location
Taiwan is well-placed in Asia with close proximity to China, Korea, and Japan. Conducting trials there may help you connect with China faster. We’ll talk about it more.
International ethical standards
Taiwanese clinical investigators are familiar with ICH-GCP (International Committee on Harmonization of Good Clinical Practice) guidelines and many are internationally trained to carry out multi-institutional clinical trial procedures. Taiwan has well-established clinical research centers with high-quality standards that strictly follow the accepted international guidelines of ICH-GCP.
Are you planning to conduct clinical trials in Taiwan?
Credevo provides a wide range of innovative development strategies, country-level, and site-level feasibility studies, global regulatory support, and clinical trial monitoring services worldwide for all your products, ranging from simple to complex ones.
Clinical trial sites in Taiwan
Here is some interesting info about sites in Taiwan.
- Currently, there are 134 hospitals in Taiwan that are qualified by the TFDA to conduct clinical trials.
- Furthermore, the National Research Program for Biopharmaceuticals has set up 13 disease-specific Taiwan Clinical Trial Consortiums to assist international pharmaceutical companies in performing clinical trials in Taiwan.
- In 2005, the National Taiwan University Hospital established the National Center of Excellence for Clinical Trial and Research (NCECTR) to meet the challenges of the growing demand for clinical trial centers with international standards.
- This reputed center, NCECTR, conducts over 600 new drug clinical trials each year, including more than 40 Phase I trials, and over 40 international clinical trials.
- Some of the famous hospitals which carry out clinical trials include:
- Koo Foundation Sun Yat-Sen Cancer Center
- Taipei Veterans General Hospital
- Linkou Chang Gung Memorial Hospital
- Tri-Service General Hospital
- National Taiwan University Hospital (NTUH)
- Chang Gung Memorial Hospital
- Taipei Medical University Hospital
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Taichung Veterans General Hospital
- Tzu Chi Medical Center
- According to the Regulations on Human Trials, all experts conducting clinical trials in Taiwan should receive human trial-related training of more than 30 hours within six years of starting a trial.
It’s possible to connect with many of these sites and investigators at Credevo. You can simply signup as a trial manager and post a project for free. This will invite feasibility feedback from Taiwanese investigators, who can be contacted for more details.
Clinical trial regulations
Currently, Taiwan ranks second in terms of the number of multinational clinical trials conducted in East Asia. In order to manage approval and oversight of such big numbers of clinical trials, a firm regulation framework has been put in place.
Emphasis has been given not only to the approval but to the actual conduct of clinical trials too. For instance, according to the regulations on human trials, all the experts who conduct clinical trials in Taiwan receive human trial-related training for more than 30 hours within six years of starting a clinical trial.
Lists of laws to conduct clinical trials and BA/BE studies in Taiwan are available at
Interesting facts about clinical trials in Taiwan
Here are five interesting facts about clinical trials in Taiwan:
- High Participation Rates: Taiwan has a strong culture of patient engagement in clinical research, often leading to high enrollment and retention rates in trials.
- Advanced Data Management: Taiwanese clinical trial sites frequently utilize sophisticated data management systems, enhancing the accuracy and efficiency of data collection and analysis.
- Rapid Regulatory Approval: The Taiwan Food and Drug Administration (TFDA) has streamlined processes for approving clinical trials, allowing studies to start more quickly compared to many other regions.
- International Collaboration: Taiwan actively collaborates with international pharmaceutical companies and research organizations, making it a hub for multi-regional clinical trials.
- Focus on Specific Diseases: Taiwan has a unique epidemiological profile, leading to a focus on clinical trials for diseases prevalent in the region, such as hepatitis B, diabetes, and cardiovascular diseases.
These factors contribute to Taiwan’s reputation as an attractive location for conducting clinical research.
Clinical trial approvals in Taiwan
We’ve discussed this important topic in Part 2 of this article. Check it out! 🙂
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