Panama

Pharmacovigilance in Panama is regulated by the Ministry of Health through the National Directorate of Pharmacy and Drugs (DNFD) and its Department of Pharmacovigilance of Medicines and Other Health Products. The National Pharmacovigilance Centre receives and evaluates suspected adverse reactions and other medicine-safety information, supports signal detection, and communicates regulatory safety measures. Marketing authorisation holders and other regulated companies are expected to operate pharmacovigilance processes consistent with Panama’s good-pharmacovigilance-practice framework and to cooperate with official oversight. The Ministry’s Resolution No. 669 of 16 October 2023 approved guidance for good-pharmacovigilance-practice inspections, reinforcing the expectation that systems, records, responsibilities, and compliance can be inspected. Companies should confirm current product-specific reporting routes and deadlines through the official DNFD pharmacovigilance portal, maintain documented case-handling, signal-management and risk-minimisation procedures, and keep evidence ready for inspection. Where the cited public sources do not expressly define local QPPV or responsible-person arrangement, pharmacovigilance system file, periodic safety reporting and risk-management plan, the MAH should confirm the current product-specific requirements with the competent authority and against the marketing-authorisation conditions. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection; Effective Signal Management in Pharmacovigilance.