For entry into the Taiwan market, all medical devices require pre-market approval. The medical device market is growing in Taiwan, but getting into the nation requires strict adherence to regulations set forth by the Taiwan Food and Drug Administration (TFDA). Manufacturers must register their products with the Taiwan Food and Drug Administration (TFDA) to sell […]
Read More →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 […]
Read More →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 […]
Read More →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 […]
Read More →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 […]
Read More →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 […]
Read More →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 […]
Read More →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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