A new approach to an old problem: Overview of the East African Community’s Medicines Regulatory Harmonization initiative

Abstract

Substandard and/or falsified medical products may result in treatment failure and/or death. The capacity to regulate medical products is key for ensuring the quality, safety, and efficacy of medical products circulating in a market. The experience of the East African Community, during its piloting of the Medicines Regulatory Harmonization initiative, serves as a lesson for scaling up the African Medicines Regulatory Harmonization Program across the continent. Currently, the East African Community’s Medicines Regulatory Harmonization initiative is poised to transition from a donor-funded pilot project into a self-sustaining, permanent feature of the African regulatory landscape. Government, partner, and public support is needed for strong systems to regulate medicines in the East African Community and elsewhere in the world.