The East African Community Medicines Regulatory Harmonization programme maintains a regional pharmacovigilance framework intended to harmonise safety and vigilance requirements across Partner States.
Core official resources
- EAC Medicines Regulatory Guidelines — the current regional library covering pharmacovigilance, post-marketing surveillance and related regulatory areas.
- EAC Pharmacovigilance documents — dedicated pharmacovigilance document collection.
What the regional framework contains
The EAC library includes guidance on safety and vigilance of medical products and health technologies, ADR/AEFI forms, patient reporting, product-quality reporting, PASS protocols and final reports, signal-detection methodology, PSMF format, pharmacovigilance methods, and DHPC planning/templates.
Practical interpretation
EAC guidance is a regional harmonisation layer, not a substitute for the legally applicable requirements and submission mechanisms of each Partner State. QPPV.com country pages for Kenya, Tanzania and Uganda should therefore be used alongside this regional resource when determining operational obligations.