{"id":181,"date":"2017-03-02T22:55:16","date_gmt":"2017-03-02T14:55:16","guid":{"rendered":"https:\/\/credevo.com\/articles\/\/?p=181"},"modified":"2024-10-31T12:25:11","modified_gmt":"2024-10-31T04:25:11","slug":"clinical-trials-in-taiwan-part-2-regulatory","status":"publish","type":"post","link":"https:\/\/credevo.com\/articles\/2017\/03\/02\/clinical-trials-in-taiwan-part-2-regulatory\/","title":{"rendered":"Understanding Taiwan’s Clinical Trial Regulatory Process: A Comprehensive Guide – Part 2"},"content":{"rendered":"\n

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 for clinical research.<\/p>\n\n\n\n

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Regulatory and approval process for conducting clinical trials in Taiwan<\/figcaption><\/figure>\n\n\n\n

Taiwan<\/strong> 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<\/a> for more details.<\/p>\n\n\n\n

In this part, let\u2019s talk a bit about the clinical trial regulatory scenario in Taiwan, including the approvals required and how to be prepared for it.<\/p>\n\n\n\n

Clinical trial approval<\/h2>\n\n\n\n

The Taiwan Food and Drug Administration (TFDA)<\/strong> with assistance from the Center for Drug Evaluation (CDE), handles applications of new drugs, medical devices, and clinical trials to fulfill regulatory requirements in line with international norms.<\/p>\n\n\n\n

Most of the essential documents, including the Chemistry, Manufacturing, and Controls (CMC) section of investigational new drugs (INDs) and new drug applications (NDAs), for clinical trial approval, can be in English.<\/p>\n\n\n\n

Steps involved in obtaining clinical trial approval in Taiwan<\/h2>\n\n\n\n

The clinical trial approval process in Taiwan involves several key steps, primarily governed by the Taiwan Food and Drug Administration (TFDA). Here\u2019s a brief overview:<\/p>\n\n\n\n

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  1. Pre-Submission Consultation<\/strong>: Sponsors can request a pre-submission meeting with the TFDA to discuss study design, regulatory requirements, and any potential issues before formally submitting their application.<\/li>\n\n\n\n
  2. Submission of Application<\/strong>: The sponsor submits a Clinical Trial Application (CTA) that includes the study protocol, informed consent forms, and necessary documents such as investigator brochures and ethics committee approvals.<\/li>\n\n\n\n
  3. Review by TFDA<\/strong>: The TFDA reviews the application for scientific validity, ethical considerations, and compliance with regulations. This process typically takes around 30 days.<\/li>\n\n\n\n
  4. Approval from Ethics Committees:<\/strong> In parallel, a registered Institutional Review Board (IRB) must approve the application to ensure the protection of participants’ rights and welfare.<\/li>\n\n\n\n
  5. Commencement of Trials:<\/strong> Once the TFDA and IRB grant their approvals, the trial can begin. The sponsor must adhere to Good Clinical Practice (GCP) guidelines throughout the study.<\/li>\n\n\n\n
  6. Monitoring and Reporting: <\/strong>The trial requires ongoing monitoring, and sponsors must report any adverse events or significant findings to the TFDA and IRB.<\/li>\n\n\n\n
  7. Final Reporting: After the trial concludes,<\/strong> sponsors must submit a final report to the TFDA that summarizes the results and any adverse events.<\/li>\n<\/ol>\n\n\n\n

    This streamlined process, along with the TFDA\u2019s commitment to facilitating research, makes Taiwan an attractive location for conducting clinical trials.<\/p>\n\n\n\n

    The current process to apply and secure approval process is as follows<\/p>\n\n\n\n

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    \"\"<\/figure><\/div>\n\n\n
    The approval process of a clinical trial in Taiwan<\/h6>\n\n\n\n

    Figure 1. The clinical trial approval process in Taiwan (Adapted from http:\/\/www.taiwanclinicaltrials.tw\/why1.php<\/a>)<\/em><\/p>\n\n\n\n

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    Need support for your clinical trials in Taiwan? <\/em><\/h3>\n\n\n\n

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    Many applicants report that, for a general (not US-FDA submitted) clinical trial, it takes about 3 months for the Taiwan FDA to give their approval. For clinical trials, approved by USFDA, approvals are quite faster (about 15 days), as discussed later in this article.<\/p>\n\n\n\n

    The TFDA issues an import permit for the import of drugs used in clinical trials. Customs will allow investigational product import into Taiwan as per the quantity on the import permit.<\/p>\n\n\n\n

    Innovative IRB Collaboration System (cIRB) for Multi-center Clinical Trial<\/h2>\n\n\n\n