Amendment of The Review Mechanism of Abbreviated Review

Regarding a new chemical entity (NCE) drug that has been approved for marketing by the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), or the Japanese Ministry of Health, Labour, and Welfare (MHLW), considering the technical documents have been reviewed and the three regulatory agencies have established a communication channel and cooperation mechanism with Taiwan, the Taiwan Food and Drug Administration (TFDA) developed abbreviated review designation in addition to the general review process to facilitate the review of the certain types of new drugs, let patients receive treatments as early as possible, and protect their rights.
 
Qualifying criteria:

1. Category I of Abbreviated Review: A new chemical entity (NCE) drug is approved by two of the three regulatory agencies (USFDA, EMA, or MHLW) with no ethnic difference in Bridging Study Evaluation (BSE). The review time is shortened to 180 days.
2. Category II of Abbreviated Review: A new chemical entity (NCE) drug is approved by the three regulatory agencies (USFDA, EMA, and MHLW) with no ethnic difference in Bridging Study Evaluation (BSE), and the Chemistry, Manufacturing and Controls (CMC) documents need to be the same. The review time is shortened to 120 days. 

【Amended date: 2019-11-18】 
【Announcement: MOHW No. 1081410630】 
 
Reference: https://www.fda.gov.tw/TC/siteListContent.aspx?sid=2984&id=32228