Coming together to improve access to medicines: The genesis of the east african community's medicines regulatory harmonization initiative

Abstract

Independent, science-based regulation of medical products is a critical part of ensuring quality healthcare. When conducted in a transparent, science-based, efficient, accountable, and predictable manner, it can help ensure access to quality products that patients need. • Several factors determine access to medicines, including treatment policy, pricing, and procurement, along with regulatory activities. Delays in regulatory filing and registration contribute to delays or lack of access to essential medicines in many African countries. • We describe the solution to this problem developed by the East African Community (EAC) and launched in 2012: The EAC Medicines Regulatory Harmonization (MRH) initiative. • Through the MRH initiative, the EAC hoped to increase the number of quality medicines that it registered by simplifying the application process for manufacturers. It also aimed to increase the speed at which it reviewed applications without decreasing rigor, by modernizing assessment processes and procedures. • The EAC MRH initiative is innovative in many ways, particularly in its decentralized structure, emphasis on work-sharing, and regulation through reliance driven by trust and goodwill.