Malawi

Pharmacovigilance in Malawi is regulated by the Pharmacy and Medicines Regulatory Authority (PMRA) under the Pharmacy and Medicines Regulatory Authority Act 2019. Section 72 of the Pharmacy and Medicines Regulatory Authority Act 2019 establishes the national pharmacovigilance system, giving the Authority responsibility for collecting, assessing and acting on medicine-safety information. Malawi has an established national pharmacovigilance centre and adverse-reaction monitoring functions, and manufacturers and authorisation holders are expected to cooperate with post-market safety surveillance and comply with PMRA safety instructions. The working public sources reviewed, however, do not clearly provide a single comprehensive MAH GVP document defining a Malawi-resident QPPV, a PSMF requirement, universal numerical ICSR submission deadlines, fixed PSUR/PBRER frequencies, a standardized RMP requirement, or a routine pharmacovigilance-inspection interval applicable to every marketed medicine. These details should therefore be confirmed from the current PMRA product-registration conditions or directly with the Authority before being treated as binding national requirements. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.