Uganda

Pharmacovigilance in Uganda is regulated by the National Drug Authority (NDA) through its National Pharmacovigilance Centre. Under the official Pharmacovigilance Regulations 2014, licensed persons, manufacturers and importers must establish appropriate systems for monitoring and managing the safety of medicines under their responsibility. The NDA may investigate a product following an adverse reaction, international safety alert, recall or other emerging concern, and withholding safety information is an offence. The Pharmacovigilance Amendment Regulations 2021 require registration holders to submit a PSUR or PBRER at least every six months during the first two years after initial registration, once every two years after that period and every three years after the subsequent period, or whenever requested by NDA. Annual reports are required for unregistered medicines supplied under an import permit. RMPs must be submitted for products specified by NDA and updated when new safety information or risk is identified. The reviewed regulations do not expressly create an EU-style QPPV or PSMF requirement. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.