إجراء مقترح من الفلبين: المنتجات الصيدلانية

Pursuant to Administrative Order (A.O.) No. 2024-0015, 'Prescribing the Rules, Requirements, and Procedures in the Application for License to Operate of Covered Health Product Establishments with the Food and Drug Administration, Repealing A.O. No. 2020-0017,' and as part of its commitment to continuous quality improvement, the Food and Drug Administration (FDA) continues to strengthen institutional efficiency through the implementation of a robust Quality Management System (QMS). This initiative supports the FDA’s ongoing efforts to accede to the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and be a World Health Organization (WHO) Listed Authority (WLA). These international standards strongly recommend having a standardized format and content for authorizations on pharmaceutical manufacturing. By aligning as well the authorization issued for other regulated pharmaceutical establishments, the FDA ensures consistency, transparency, and proper monitoring across all issued licenses. This also facilitates compliance with internationally accepted practices and promotes ease of verification by both local and foreign regulatory bodies. In line with these initiatives, the FDA issues this Circular to establish the contents of License to Operate (LTO) issued by the FDA for pharmaceutical establishments.