Library / regulatory-reference
Taiwan: Food and Drug Administration (TFDA)
Audience: administrators-policy, researchers-scientists ยท Review state: published
The national authority
The Taiwan Food and Drug Administration is Taiwan's national regulator for medicines, medical devices, food and cosmetics, operating under the Ministry of Health and Welfare.
Taiwan's market is large and technologically advanced, and the administration covers a wide product range from drugs and devices to food safety.
How products enter the market
Medicines and devices require approval after evaluation of quality, safety and efficacy, and manufacturers are inspected against good-manufacturing-practice standards.
Post-market work includes adverse-event reporting, product recalls and public alerts.
Regional and international role
The administration engages with international regulatory forums and harmonization initiatives in the region.
Its combined oversight of drugs, devices and food makes it a useful example of a broad integrated regulator.
Using this profile
The authority publishes regulations, registers and alerts in Chinese and English through its official portal, which is the primary source for current rules and listed in this profile's internal reference record.
For cross-country comparison: Taiwan illustrates the broad integrated regulator: drugs, devices, food and cosmetics under one administration.
Limitations
Educational profile of a national regulatory system, current as of drafting. It simplifies routes and classes and is not legal, regulatory, or clinical advice. Filing and compliance decisions must be confirmed against the authority's current published rules and, where needed, professional regulatory counsel.