Improving access to quality medicines in east Africa: An independent perspective on the east African community medicines regulatory harmonization initiative

Abstract

The goal of improving access to quality medicines in East Africa has been addressed by the East African Community (EAC) Medicines Regulatory Harmonization (MRH) initiative, which is working to simplify the process of registering medicines and increase the speed at which registration applications are reviewed while ensuring that only highquality medicines are approved. • This article was written by a group of authors with varied expertise in global regulatory affairs but no involvement to date in the EAC MRH initiative. The authors were asked to provide an independent perspective on the initiative’s work since its launch in 2012, as well as its plans for the future. • The authors believe that the strengths of the EAC MRH’s initiative include its rapid implementation of a joint product assessment process, by which a manufacturer can submit a single marketing authorization application and receive a decision respected by all EAC member states, as well as the creation and use of a common technical document (CTD) for registration applications that is accepted by all member states. In addition, the initiative’s twinning program, in which more mature national regulatory authorities carry out joint activities alongside less mature authorities, is an excellent way to build the capacity of all partner states. • The authors believe the EAC MRH initiative may be able to further improve access to essential medicines by increasing transparency, inviting and responding to feedback from industry partners, consistently meeting its advertised assessment and registration timelines, streamlining the joint product assessment process, taking advantage of work done by peer institutions, focusing on the activities most likely to have the greatest public health return, and using metrics and benchmarks to identify opportunities for greater efficiency. The initiative may be able to maintain and even expand its activities by charging industry user fees. This will become increasingly important as the scope of the initiative grows to include a greater emphasis on pharmacovigilance activities and, as more medicines undergo the joint approval process, handling the postapproval regulatory burden. • Strengthening the EAC MRH’s legal framework, such that member states are legally required to respect joint regulatory decisions instead of being bound only by goodwill, will also be important for securing the initiative’s future.