Safety of Medicinal Products in the Philippines: Assessment of the Pharmacovigilance System and its Performance

The Food and Drug Administration (FDA) Philippines, with support from the US Agency for International Development (USAID)-funded Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program conducted an assessment of the Philippines’ pharmacovigilance (PV) system and its components. They are (1) governance, policy, law, and regulation; (2) systems, structures, and stakeholder coordination; (3) signal generation and data management; (4) risk assessment and evaluation; and (5) risk management and communication, using the Indicator-based Pharmacovigilance Assessment Tool.

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