Harmonization of medical products regulation: a key factor for improving regulatory capacity in the East African Community

Abstract

Background Limited capacity to regulate medical products is associated with circulation of products which do not meet standards of quality, safety and efficacy with negative public health and economic outcomes. This study focused on assessing the effect of the East African Community (EAC) medicines regulatory harmonization initiative on the capacity of national medicines regulatory agencies, with a focus on registration and inspection systems. Methods An exploratory mixed-method design using both qualitative and quantitative data to access data from six national medicines regulatory authorities (NMRAs) and the EAC Secretariat. Data was collected using a combination of semi-structured interviews, questionnaires, and checklists for the period 2010/11–2015/16 with 2010/11 data serving as baseline. Heads of NMRAs, regulatory and monitoring and evaluation experts, and the EAC Secretariat Project Officer were enrolled in the study. A set of 14 indicators grouped into 6 categories were used to assess NMRAs performance. Results Policy and legal frameworks provide a foundation for effective regulation. Collaboration, harmonization, joint dossier reviews and inspections of manufacturing sites, reliance and cooperation are key factors for building trust and capacity among NMRAs. Five out of six of the EAC Partner States have comprehensive medicines laws with autonomous NMRAs. All the NMRAs have functional registration and good manufacturing practice inspection systems supported by regional harmonised guidelines for registration, inspection, quality management and information management systems with four NMRAs attaining ISO 9001:2015 certification. Conclusions The EAC regulatory harmonization initiative has contributed to improved capacity to regulate medical products. The indicators generated from this research can be replicated for evaluation of similar initiatives across and beyond the African continent and contribute to public health policy.

Using cross-species vaccination approaches to counter emerging infectious diseases

“…However, this strategy would be successful only if the bulk material was stable in the long term and a regulatory approval strategy incorporating veterinary and human considerations was in place. Harmonized regulatory processes allowing mutual recognition of vaccine registration procedures between countries are already in place, aiming to address operational bottlenecks that limit rapid access to licensed human and veterinary vaccines 84 , 85 .…”

Advancing African Medicines Agency through Global Health Diplomacy for an Equitable Pan-African Universal Health Coverage: A Scoping Review

“…Restricted regulatory ability is related to the circulation of medical goods that do not meet quality, safety, and efficacy resulting in negative public health and economic consequences. A recent exploratory study by Sigonda et al assessed the effect of the East African Community medicines regulatory harmonization initiative on the capacity of six NRMAs found that the initiative has contributed to improved capacity to regulate medical products [18].…”

“…The goal of the AU Model Law is to encourage cross-national collaboration and ensure that promising medical innovations are developed, evaluated, and scaled up for greater health impact [63][64][65][66][67]. The AU Model Law also supports the AU's purpose of promoting local pharmaceutical manufacture for public health and economic progress [4] and continental initiatives to advocate for and catalyze access to new medical products for people in need [12,18,65]. Moreover, Chattu et al emphasized that the AU should leverage the momentum of the rise of GHD to navigate the politics of global health governance in an interconnected world and develop robust preparedness and disease response strategies.…”

Importation and distribution of unregistered medicines in the public sector: similarities, differences, and shared challenges among Southern African Development Community (SADC) countries

“…Medical products are allowed for use after the respective NRAs approve them. The requirements to obtain such approval differ among NRAs based on their regulatory capacity [ 9 , 10 ]. The regulatory review process requires a considerable amount of time and adequate skilled personnel, impacting the availability of registered medicines [ 9 , 11 ].…”

“…A WHO report estimates that only 30% of NRAs among its Member States can effectively and efficiently regulate medical products in their countries [ 12 ]. WHO and its Member States require that medical products be registered; this involves the regulatory review of the quality, safety and efficacy data, good manufacturing practice inspection and licensing of the concerned manufacturing site before approval for marketing [ 10 , 11 , 13 ]. Such medical products may or may not have obtained the relevant authorization from the NRA in the source market [ 14 , 15 ].…”