Category: Regulatory

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Understanding Taiwan’s Clinical Trial Regulatory Process: A Comprehensive Guide – Part 2

Taiwan offers a supportive and efficient regulatory landscape for clinical trials, primarily managed by the Taiwan Food and Drug Administration (TFDA). The TFDA simplifies the approval process and provides expedited reviews for innovative therapies, allowing studies to start more quickly. With its advanced healthcare facilities and diverse patient population, Taiwan has become an attractive destination […]

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Thailand Clinical Trial Regulatory Scenario: Update 1

Recently, the Thailand FDA has brought a revised list of Institutional Review Boards (IRBs)/Ethics Committees (ECs) that it recognizes for acceptance of clinical trial applications. In our previous articles (see Part I and Part II), we’ve discussed the regulatory scenario in Thailand, including We’ve also presented a list of ethics committees that are recognized for application to the […]

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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 […]

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Clinical Trial Regulatory & Approval Process In Thailand (Part-2)

Thailand furnishes a good infrastructure, and a robust and flexible regulatory process to conduct clinical trials. There is a rise in the interest of many pharma companies and research organizations in conducting clinical trials in Thailand. Continuation from Clinical Trial Regulatory & Approval Process In Thailand (Part-1). We often receive queries from pharmaceutical companies and clinical […]

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Clinical Trial Regulatory & Approval Process In Thailand (Part-1)

Among 10 ASEAN countries, Thailand registers the highest number of clinical trials in the region, and the number of BA/BE studies is increasing. The regulatory process and requirements to conduct clinical trials in Thailand are of interest to many pharmaceutical companies. We often receive queries from pharmaceutical companies and clinical research organizations asking about the […]

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