Sao Tome and Principe

Pharmacovigilance in Sao Tome and Principe is overseen by the Ministry of Health through the Pharmaceutical Department (Departamento Farmacêutico—DF), which regulates and supervises pharmaceutical activities and monitors the production, distribution, commercialization, and use of medicines and health products. The National Pharmaceutical Policy 2019–2029 identified the need to strengthen the legal, organisational, and physical foundations of pharmacovigilance, while the Pharmaceutical Master Plan 2021–2025 proposed establishing ARFAMED as an autonomous medicines authority with a dedicated pharmacovigilance service. The World Health Organization now lists Sao Tome and Principe as a full member of the WHO Programme for International Drug Monitoring since 2025, enabling national safety reports to contribute to VigiBase. Publicly available national sources do not currently establish blanket requirements for every marketing authorisation Holder (MAH) to appoint a resident QPPV, maintain a local PSMF, or follow defined national ICSR and PSUR/PBRER submission timelines. Companies and importers should therefore confirm product-specific obligations directly with the Pharmaceutical Department and maintain documented processes for collecting, evaluating, and promptly communicating adverse reactions, safety signals, recalls, and other significant safety information. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.