ICH E2D Harmonized Guideline- Post Approval Safety Data: Definitions And Standards For Management And Reporting Of Individual Case Safety Reports
NAFDAC has been accepted as Observer Expert in the ICH technical working group, and the E2D TWG are in the process of finalizing the Post-Approval Safety Data Definitions and Standards for Management and Reporting of Individual Case Safety Reports (ICSRs). As NAFDAC stakeholders we would like to kindly request that you make your input before 30th of […]
