Optimizing the East African Community’s Medicines Regulatory Harmonization initiative in 2020–2022: A Roadmap for the Future

Points• The East African Community (EAC)'s Medicines Regulatory Harmonization (MRH) initiative was created to improve access to quality, safe medicines in the region by simplifying the regulatory process while maintaining a high level of rigor.Building on lessons learned since its launch in 2012, the EAC MRH initiative has created a Roadmap for the Future.• The capacity to monitor and reports adverse drug reactions is key for patients' safety.Therefore, going forward, drug safety and quality surveillance will be a priority for the EAC MRH initiative.• In the future, other key success factors for the initiative will include establishing a cadre of regional technical officers (RTOs), a Cooperation Framework Agreement between the national medicines regulatory authorities (NMRAs) of EAC Partner States, and a sustainable funding mechanism for regional assessment.• Widening the scope of medical products considered (and focusing on those not eligible for the World Health Organization [WHO]'s Prequalification Programme) will also add value to the EAC MRH initiative.• Implementing the EAC MRH initiative's agreed upon roadmap will lead to a stronger, more efficient, and more accountable region-wide regulatory system, thus improving access to quality, safe medicines for EAC residents.