In Taiwan, the clinical data submission guidelines for biologics require applicants to provide comprehensive clinical trial data proving safety, efficacy, and immunogenicity. Submissions must follow ICH standards and include pharmacokinetics and pharmacodynamics data. The TFDA may require bridging studies to confirm the... Read More
In Taiwan, extending a drug’s expiry date requires conducting long-term stability studies on three production batches, ensuring the product maintains safety, efficacy, and quality. The results must align with TFDA guidelines and international standards. Manufacturers must submit these findings for review, with... Read More
In Taiwan, drug shelf life is determined through stability testing conducted under TFDA guidelines. The tests assess physical, chemical, and microbiological stability under controlled conditions such as temperature and humidity. Results from long-term, accelerated, and intermediate studies must meet ICH standards, ensuring... Read More
In Taiwan, drug stability testing must follow TFDA guidelines to ensure product quality, safety, and efficacy throughout its shelf life. Testing evaluates physical, chemical, and microbiological stability under varying environmental conditions, such as temperature and humidity. The results must comply with ICH... Read More
In Taiwan, the TFDA regulates drug packaging inserts to ensure they provide accurate information on dosage, indications, side effects, and precautions. Inserts must be in Chinese and comply with formatting guidelines. Companies upload inserts to an electronic platform for TFDA review, enhancing... Read More
To register controlled substances in Taiwan, applicants must obtain a controlled drugs registration license from the TFDA, adhering to the Controlled Drugs Act. The process involves submitting documentation on manufacturing, storage, and safety protocols while ensuring GMP compliance. Controlled substances are categorized... Read More
Taiwan’s Free Trade Agreements (FTAs) promote faster market access by harmonizing regulatory processes and facilitating drug imports. These agreements align intellectual property protections with international standards, benefiting innovative medicines. However, stricter patent rules under FTAs may delay the availability of generics, impacting... Read More
New drug delivery systems in Taiwan are registered by submitting a New Drug Application (NDA) to the TFDA, including detailed data on the delivery mechanism’s safety, efficacy, and stability. Applicants must demonstrate Good Manufacturing Practice (GMP) compliance and provide supporting clinical studies.... Read More
International harmonization supports Taiwan’s drug registration by aligning TFDA regulations with global standards, such as those from the International Council for Harmonisation (ICH). This alignment streamlines the use of foreign clinical data and encourages data sharing. Participation in international forums ensures Taiwan’s... Read More
The TFDA monitors drug side effects in Taiwan through a pharmacovigilance system that requires manufacturers to report adverse events and submit Periodic Safety Update Reports (PSURs). The TFDA collaborates with healthcare providers to track incidents and may conduct inspections or request further... Read More