In Taiwan, prescription drugs must comply with TFDA regulations, including submission of clinical data proving safety, efficacy, and quality. They require Good Manufacturing Practice (GMP) certification and proper labeling in Chinese. Prescription-only medicines can only be dispensed by licensed healthcare professionals, and... Read More
To register herbal medicines in Taiwan, applicants must submit documentation proving safety, efficacy, and quality. The TFDA requires data on ingredients, manufacturing processes, and stability. Compliance with Good Manufacturing Practice (GMP) is essential, along with clear labeling in Chinese. Some products may... Read More
To register biosimilars in Taiwan, applicants must submit data proving similarity to the reference product in terms of safety, efficacy, and quality. The process requires comparative clinical trials, pharmacokinetic studies, and compliance with Good Manufacturing Practice (GMP). The TFDA may expedite reviews... Read More
Taiwan’s fast-track approval process accelerates access to drugs addressing urgent medical needs, such as orphan drugs or treatments for serious conditions. The TFDA offers expedited pathways, including priority review, accelerated approval, and abbreviated review, reducing evaluation timelines. These programs ensure timely patient... Read More
Drug pricing in Taiwan is regulated by the National Health Insurance Administration (NHIA). New drugs are priced based on the average or lowest prices among ten reference countries, depending on classification. The NHIA also uses specific pricing formulas for generics and biosimilars,... Read More
The TFDA’s technical review plays a crucial role in drug registration by thoroughly evaluating the drug’s safety, efficacy, and quality. It involves analyzing clinical and non-clinical data, manufacturing processes, and compliance with Good Manufacturing Practice (GMP) standards. This review ensures the drug... Read More
In Taiwan, registering over-the-counter (OTC) drugs requires submitting product information, including ingredients, labeling, dosage, and intended use, to the TFDA. Compliance with Good Manufacturing Practice (GMP) is mandatory, along with safety and stability data. Labels must be in Chinese, providing clear usage... Read More
In Taiwan, non-compliance with drug registration regulations can result in fines, license suspensions, product recalls, or bans on manufacturing and import activities. Severe violations, such as endangering public health or falsifying data, may lead to criminal charges. The TFDA enforces these penalties... Read More
In Taiwan, non-compliance with drug registration regulations can result in fines, product recalls, or license suspensions. Violations, such as marketing unauthorized drugs or failing to meet GMP standards, are strictly penalized. Severe cases may lead to criminal charges, with further actions if... Read More
In Taiwan’s drug registration process, intellectual property (IP) issues are handled through a patent linkage system under the Pharmaceutical Affairs Act. NDA holders must list relevant patents, and generic manufacturers cannot rely on protected data during the exclusivity period. Patent disputes are... Read More