Abstract
Introduction: National medicines regulatory agencies are faced with challenges including limited resources and technical capacity, resulting in countries collaborating and sharing resources to improve efficiency of the review process to facilitate access to quality-assured medicines by their populations. One such collaboration is the Southern African Development Community (SADC) medicines registration collaborative initiative, ZaZiBoNa. Countries participate in the initiative by contributing to regulatory reviews and good manufacturing practices inspections. The aim of this study was to review and compare the registration processes of regulatory authorities of Mozambique, Namibia, South Africa, Tanzania, Zambia, and Zimbabwe to identify strategies for better alignment.Methods: A senior member of the division responsible for issuing marketing authorisations completed an established and validated questionnaire, which standardises the review process, allowing key milestones, activities and practices of the six regulatory authorities to be identified and compared. The completed questionnaires were validated by the heads of the respective agencies.Results: The six countries vary in population and in the size of their respective regulatory agency and the resources allocated to regulatory reviews. The review processes of the six agencies were similar; however, differences were noted in the milestones recorded; for example, two of the countries did not record the start of the scientific assessment. Additionally, decisions for marketing authorisation were made by an expert committee in four of the countries and by the head of the agency and the Minister of Health in two countries. All six agencies implemented the majority of good review practices; however, the need for improvement in the areas of transparency and communication and quality decision making practices was a common finding for all six countries.Conclusions: Participation in the ZaZiBoNa initiative has improved the way in which the six agencies perform regulatory reviews in their countries, highlighting the realisation of one of the key objectives of the initiative, which was building the expert capacity of member countries. Other agencies in the SADC region and beyond can use the results of this study to identify best practices, which in turn, could improve their regulatory performance.
Highlights
National medicines regulatory agencies are faced with challenges including limited resources and technical capacity, resulting in countries collaborating and sharing resources to improve efficiency of the review process to facilitate access to quality-assured medicines by their populations
The six regulatory agencies included in this study were the National Directorate of Pharmacy in the Mozambique Ministry of Health; Namibia Medicines Regulatory Council (NMRC) in the Namibia Ministry of Health and Social Services; the South African Health Products Regulatory Authority (SAHPRA); the Tanzania Medicines and Medical Devices Authority (TMDA); the Zambian Medicines Regulatory Authority (ZAMRA); and the Medicines Control Authority of Zimbabwe (MCAZ)
A common finding among the six regulatory authorities was that participation in the ZaZiBoNa initiative has improved the way in which they perform regulatory reviews in their countries, and this highlights how one of the key objectives of the initiative, which is to build expert capacity of member countries is being realised
Summary
National medicines regulatory agencies are faced with challenges including limited resources and technical capacity, resulting in countries collaborating and sharing resources to improve efficiency of the review process to facilitate access to quality-assured medicines by their populations One such collaboration is the Southern African Development Community (SADC) medicines registration collaborative initiative, ZaZiBoNa. Countries participate in the initiative by contributing to regulatory reviews and good manufacturing practices inspections. The countries have differing capacities to regulate medicines [2], they share the common challenge of inadequate capacity to review applications for medicines, resulting in backlogs and delayed access to medicines by patients This led to the formation of a collaborative medicines registration initiative called ZaZiBoNa by four countries, Zambia, Zimbabwe, Botswana, and Namibia with technical support from the World Health Organization (WHO) Prequalification team in 2013 [3]. The remaining countries, Mauritius and Lesotho, participate as observers [3].
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