TFDA Strengthens Orphan Drug Access with Policy Reforms

      Taiwan has been proactive in supporting rare disease patients through comprehensive policies. Since the 2000 passage of the Rare Disease Prevention and Drug Act, Taiwan has legally protected rare disease patients by integrating early diagnosis, treatment support, and orphan drug development. Orphan drugs are covered under Taiwan’s National Health Insurance (NHI), reducing financial burdens and ensuring better access to critical treatments. To further improve accessibility, the Taiwan Food and Drug Administration (TFDA) has introduced faster approval mechanisms, special importation programs, and regulatory updates to help patients receive life-saving medications more efficiently.       To accelerate access to internationally approved orphan drugs, TFDA launched the Orphan Drug Recognition and Expedited Registration Pilot Program in July 2023​. This initiative reduces the approval time from 300 to 240 days for drugs already authorized by the U.S. FDA, EMA, or Japan’s MHLW, allowing quicker market entry. The program streamlines applications by allowing simultaneous orphan drug recognition and market registration, ensuring that pati...