Announcement of Real-world Evidence－Considerations in Evaluating the Relevance and Reliability

Applying real-world evidence to clinical trials is the latest global trends. 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, Guidance for Real-world Evidence－Considerations in Evaluating the Relevance and Reliability, for helping the industry to adopt and apply the guidance during drug development.
 
【Issue date: 2021-03-17】 
【Announcement: FDA No. 1101401345A】 
 
Reference: https://www.fda.gov.tw/TC/siteListContent.aspx?sid=9354&id=36082