Announcement of Points of Attention in Using Real-world Data/Real-world Evidence as Technical Documents in Drug Registration Review

Applying real-world evidence (RWE) to clinical trials is the latest global trends. RWE can also optimize the design of clinical studies and be used as supplemental evidence for both pre- and post-approval efficacy or safety evaluation of pharmaceuticals. Every country all gives priority to the development of real-world evidence application and makes related regulations. Therefore, according to the global trends in management and the situation in Taiwan, Food and Drug Administration, Ministry of Health and Welfare, issued an announcement, Points of Attention in Using Real-world Data/Real-world Evidence as Technical Documents in Drug Registration Review, for helping the industry to adopt and apply it during drug development.
 
【Issue date: 2021-07-02】 
【Announcement: FDA No. 1101406217A】 
 
Reference: https://www.fda.gov.tw/TC/siteListContent.aspx?sid=9354&id=37181