Thailand FDA periodically releases a list of institutional review boards (IRBs) / ethics committees (ECs) that it recognizes for acceptance of clinical trials. Under Thailand’s regulatory system, approved ethics committees serve as the main point of approval for initiating clinical trials in the country. It has been explained in our previous articles (see Part I […]

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Generic drug registration in Thailand can be a streamlined process, particularly if you understand the relevant regulations and requirements. Familiarity with the regulatory landscape and compliance criteria can significantly simplify the application and approval process for generic drug registration in Thailand, making it a more manageable and efficient undertaking. Thailand is the second-largest healthcare market […]

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Taiwan is emerging as a big player in the Asian clinical trial market. Taiwan has many advantages for conducting clinical trials. Refer to Part 1 of this blog for more details. In this part, let’s talk a bit about the clinical trial regulatory scenario in Taiwan, including the approvals required and how to be prepared for it. Top […]

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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 regulatory approvals for the clinical trial in Thailand, ethics committee approval for the clinical trial […]

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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 […]

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Thailand furnishes a good infrastructure, 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 receive queries, often from pharmaceutical companies and clinical research […]

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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 receive queries, often from pharmaceutical companies and clinical research organizations, asking about the […]

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