In Taiwan, Active Pharmaceutical Ingredients (APIs) are regulated by the TFDA to ensure quality and safety. Manufacturers must comply with Good Manufacturing Practice (GMP) standards, and imported APIs require documentation proving compliance from the country of origin. Regular inspections and quality assessments... Read More
To register a generic drug in Taiwan, applicants submit an abbreviated application to the TFDA, proving bioequivalence with the original product. The process also requires compliance with Good Manufacturing Practice (GMP), along with manufacturing, quality, and labeling data. If complete, approvals typically... Read More
The TFDA ensures drug safety through pharmacovigilance programs and post-market surveillance, requiring companies to submit Periodic Safety Update Reports (PSURs). It monitors adverse events, conducts inspections, and mandates further studies or label updates when necessary. The TFDA collaborates with healthcare professionals to... Read More
For drug registration in Taiwan, non-clinical study requirements include toxicology studies to assess potential risks, pharmacology studies to demonstrate biological activity, and pharmacokinetics to evaluate absorption, distribution, metabolism, and excretion. These studies ensure the drug’s safety before human trials. Compliance with international... Read More
Common reasons for drug registration rejection in Taiwan include incomplete documentation, non-compliance with Good Manufacturing Practice (GMP), insufficient clinical evidence of safety and efficacy, or discrepancies in foreign clinical data. Applications may also fail due to missing bridging studies or incorrect labeling... Read More
In Taiwan, drug labeling requirements are enforced by the TFDA to ensure accurate and clear information for safe use. Labels must comply with TFDA guidelines, including details on dosage, ingredients, side effects, and usage instructions in Chinese. The TFDA conducts inspections and... Read More
The Ministry of Health and Welfare (MOHW) oversees Taiwan’s drug registration through policy development and regulation enforcement. It supervises the TFDA, ensuring drugs meet safety, efficacy, and quality standards. The MOHW also coordinates public health initiatives, influences drug pricing policies, and ensures... Read More
Yes, you can appeal a drug rejection decision in Taiwan by submitting a formal reconsideration request to the TFDA. The appeal must include additional data or clarifications addressing the reasons for rejection. Engaging in consultations with TFDA officials can help resolve issues... Read More
If a drug application is rejected in Taiwan, the TFDA provides feedback detailing the reasons, such as incomplete data or non-compliance with regulations. Applicants can address the issues and resubmit the application. In some cases, additional studies may be required. Engaging with... Read More
Post-marketing surveillance in Taiwan ensures ongoing drug safety by monitoring adverse events and effectiveness after market entry. The TFDA requires pharmaceutical companies to submit Periodic Safety Update Reports (PSURs) and conduct pharmacovigilance activities. If necessary, additional studies or labeling changes may be... Read More