How Do You Submit A New Drug Application (NDA) In Taiwan?

To submit a New Drug Application (NDA) in Taiwan, you must provide clinical trial data, quality assessments, and manufacturing information through the Taiwan FDA’s (TFDA) e-submission platform. The application must comply with Good Manufacturing Practices (GMP) and may require translation into Chinese. After submission, the TFDA reviews the data for safety, efficacy, and quality.

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