Taiwan's pharmacovigilance framework is administered by the Taiwan Food and Drug Administration (TFDA) under the Pharmaceutical Affairs Act and related reporting regulations.
Core official resources
- Regulations for Reporting Serious Adverse Reactions of Medicaments — official English-language regulation governing serious ADR reporting.
- TFDA adverse-drug-reaction reporting portal — national reporting-system information, forms and operational guidance.
- Serious ADR reporting regulation — Chinese — current Chinese regulatory text.
Practical use
The current TFDA rules require pharmaceutical firms to report serious adverse drug reactions through the designated online system within the applicable statutory timelines. The 2025/2026 official pages also describe the required data elements and permit ICH-standard electronic transmission formats.