Central African Republic

Medicines regulation in the Central African Republic is overseen by the Ministry of Health and Population. The official National Health Policy 2019-2030 addresses pharmaceutical regulation and the strengthening of medicines safety and health-system functions. A publicly available standalone national MAH Good Pharmacovigilance Practice guideline was not identified in current official sources, and the available official material does not establish a local QPPV, EU-style PSMF, fixed MAH ICSR timelines, or universal PSUR/RMP submission requirements. These obligations are not established as mandatory without direct confirmation from the competent Ministry for the relevant product and authorisation. Where the cited public sources do not expressly define signal management and audit and inspection arrangements, 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): Effective Signal Management in Pharmacovigilance.