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

BackgroundThe purpose of the study was to assess the requirements for approval of the importation of unregistered medicines for use in the public sector in the Southern African Development Community (SADC) countries.MethodsThe study reviewed the legal provisions and requirements to be fulfilled when importing unregistered medicines for the public sector in SADC countries relative to two comparators drawn from countries with stringent regulatory systems through extant document analysis. The relative implementation index score was calculated and used to measure the level of implementing legal provisions and requirements to be fulfilled. Analysis was performed using the STATA software package. ResultsApproximately 13 out of 16 SADC countries had a relative implementation index below 50%. The aggregated implementation index across all SADC countries was 44%, ranging from 4% to 54%, while the two comparators had a relative implementation index of 81% and 85%, respectively.ConclusionImplementing the minimum requirements for importing unregistered medicines for the public sector was deficient compared to the jurisdictions with stringent regulatory systems, and wide implementation gaps also existed within the SADC region.

Nexus of firm characteristics and financial performance of non-life insurance companies in the Southern African Development Community

In almost all emerging and developed nations, the insurance industry is one of the most important participants of the financial services sector. As a result, the goal of this study is to investigate the firm characteristics and drivers of financial performance using 121 publicly traded non-life insurance companies from 16 Southern African Development Community (SADC) countries during the period from 2008 to 2019. The consolidated least squares and two-step generalized method of moments estimators were used to analyze a panel data set of 1,452 observations. The findings show that a lagged return on assets, equity capital, operational efficiency, leverage and investment capability are statistically significant determinants of financial performance in non-life insurance companies of SADC countries, even though equity capital, operational efficiency, and leverage are inversely significant. The insurance industry, policymakers, the state, and shareholders should consider these important variables when making decisions, and enhance their performance according to the findings. It is also suggested that the industry’s capital structures should be reformed to preserve a favorable balance of equity and debt amongst the businesses. Additionally, measures such as automated systems that may decrease operating costs should be used to improve financial performance.

Ending Mozambique’s insurgency may prove complex

Significance Operations spearheaded by Rwandan military and police have recaptured the strategic towns of Palma and Mocimboa da Praia, and are now targeting the insurgents’ rural bases, while troops from the Southern African Development Community (SADC) are now also on the ground. Impacts The insurgency’s collective leadership will face strains as different elements come under attack and its supply chains are disrupted. The intervention will confirm Tanzania and Rwanda’s regional foreign policy sway, with possible implications for engagement in Congo. The rapid successes of Rwandan forces highlight the gulf in expertise, and possibly will, between them and their Mozambican counterparts.

Evaluation of the Good Review Practices of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward

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.

Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward

Introduction: Regulatory reliance, harmonization and work sharing have grown over the last few years, resulting in greater sharing of work and information among regulators, enabling efficient use of limited resources and preventing duplication of work. Various initiatives on the African continent include ZaZiBoNa, the Southern African Development Community (SADC) collaborative medicines registration initiative. ZaZiBoNa has resulted in great savings in time and resources; however, identified challenges include lack of clear information regarding the participating countries registration processes and requirements as well as lengthy registration times. The aim of this study, therefore, was to compare the data requirements and review models employed in the assessment of applications for registration, the target timelines for key milestones and the metrics of applications received and approved in 2019 and 2020 by Mozambique, Namibia, South Africa, Tanzania, Zambia, and Zimbabwe.Methods: A senior member of the division responsible for issuing marketing authorisations completed an established and validated questionnaire, which standardizes 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 majority of applications received and approved by all six agencies in 2019 and 2020 were for generics. The mean approval times for generics varied across the countries, with ranges of 218–890 calendar days in 2019 and 158–696 calendar days in 2020. All three types of scientific assessment review models were used by the six agencies and data requirements and extent of scientific assessment were similar for five countries, while one conducted full reviews for new active substances. A large variation was observed in the targets set by the six agencies for the different milestones as well as overall approval times.Conclusions: The study identified the strengths of the countries as well as opportunities for improvement and alignment. Implementation of the recommendations made as in this study will enhance the countries' individual systems, enabling them to efficiently support the ZaZiBoNa initiative.