Tag: Thailand

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Nutraceuticals & Food Supplements Registration Process In Thailand

The nutraceuticals and food supplements registration process in Thailand involves a comprehensive series of steps to ensure the safety, efficacy, and compliance of products entering the market. This process entails careful documentation, scientific substantiation of health claims, adherence to regulatory guidelines, and collaboration with regulatory experts. While timelines can vary, companies should anticipate a thorough […]

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Clinical Study Coordinators & Monitors in Thailand: Qualifications, Responsibilities, and Regulatory Compliance

In the realm of clinical research in Thailand, clinical study coordinators and monitors play a vital role in ensuring the smooth execution of trials while adhering to regulatory compliance. In the dynamic landscape of clinical research in Thailand, the pivotal roles of clinical study coordinators and monitors cannot be overstated. These dedicated professionals are at […]

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Finding Clinical Research Associates For Clinical Trials In Thailand

Clinical research is a field that can be difficult in and of itself. So it is essential to understand the knowledge and skill requirements for the various roles. A healthcare professional who oversees various duties for clinical trials and other kinds of medical research is a clinical research associate (CRA). A clinical research associate does […]

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Thailand Latest Approved IRB List: Update 2

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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Marketing Authorization & Regulatory Requirements For Drug Registration In Thailand

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

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Ovarian Cancer: Clinical Trial Feasibility

With patients with ovarian cancer as the target trial population, clinical trial feasibility was performed. The clinical trial sites/investigators, who participated in this feasibility came mainly from India, Russia, the Philippines, Vietnam, Thailand, and South Korea. What are the causes of ovarian cancer? The causes of ovarian cancer are unclear but doctors have identified factors that […]

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Clinical Trial Feasibility: Breast Cancer Studies

Worldwide, breast cancer is the most common invasive cancer in women. Along with lung cancer, breast cancer is the most commonly diagnosed cancer, with 2.09 million cases each in 2018, and Breast cancer affects 1 in 7 (14%) of women worldwide. What is breast cancer? Breast cancer is a cancer that develops from breast tissue. […]

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

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

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