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

• DOI: 10.1186/s12889-021-10169-1
• Publication Date: 2021-01-21T12:04:18Z
• Authors: Margareth Ndomond...; Jacqueline Miot; Shan Naidoo; Nelson E. Masota; Brian Ng’andu; Nancy Ngum; Eliangiringa Kaale
• Keywords: Harmonization; Capacity Building

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