MFDS Identifies GCP Gaps in Dayvigofilm Coating Tablet (Rembolexant) Approval Process

The Ministry of Food and Drug Safety (MFDS) conducted a Good Clinical Practice (GCP) compliance survey related to the product approval of Korean Jae’s insomnia medication, Dayvigofilm coating tablet (Rembolexant). The survey revealed the need for improvements in compliance with the clinical trial protocol, monitoring activities, and documentation management. At Keimyung University Dongsan Hospital, some observations were classified as “important,” but no “serious” findings that would trigger administrative sanctions were identified. The corrective action plan submitted by the sponsor was accepted as appropriate. The findings were recently published on the Drug Safety Korea portal, referencing the Pharmaceutical Act Article 34.