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Harmonised Guidelines 2014

East Africa Harmonisation of medicine regulation guidelines: KAPI was involved in several stakeholder engagement meetings with the EAC-MRH team and PPB to offer critical advice and comments on the harmonised guidelines that culminated in the successful launch of the model law and guidelines for three pillars: The EAC adopted the final EAC harmonized technical guidelines, standards and requirements for Medicines Evaluation and Registration (MER), Good Manufacturing Practices (GMP) inspections, Quality Management System (QMS) requirements for National Medicines Regulatory Authorities and recommended the same to the EAC Council of Ministers for consideration and approval, (EAC/SCM/Health/Decision 049) in 2014.