Announcement of The Key Points of Pediatric and Rare Severe Disease Priority Review Voucher Program

Ministry of Health and Welfare issued an announcement, The Key Points of Pediatric and Rare Severe Disease Priority Review Voucher Program, intended to encourage manufacturers to develop drugs to treat pediatric or rare severe diseases. The Taiwan Food and Drug Administration (TFDA) granted this application Pediatric and Rare Severe Disease Priority Review designation to simplify and speed up review process for helping those patients in life-threatening conditions access to drugs.

All of the qualifying criteria below shall be met:

1. The term “new drugs” defined in Article 7 of the Pharmaceutical Affairs Act.
2. A drug is intended to treat a serious condition.
3. The disease is mainly prevalent in pediatric population; or the prevalence of the disease is less than five per ten thousand.
4. A drug is intended to address an unmet medical need.

【Issue date: 2019-11-18】
【Announcement: MOHW No. 1081410630】

Reference: https://www.fda.gov.tw/TC/siteListContent.aspx?sid=2984&id=32228