Announcement of Clinical Safety Data Management: Definitions and Standards for Expedited Reporting

To construct a harmonised regulatory environment for a guidance of reporting clinical safety data for pharmaceuticals and to help the industry to adopt and apply the Clinical Safety Data Management, the Food and Drug Administration, Ministry of Health and Welfare, issued an announcement, Guidance for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting.
 
【Issue date: 2021-01-13】 
【Announcement: FDA No. 1091412537A】 
 
Reference: https://www.fda.gov.tw/TC/siteListContent.aspx?sid=9354&id=35722