World Bank / SADC - Scoping system requirements for harmonised Southern African Development Community (SADC) medicine regulatory to increase access to safe, effective, and affordable essential medicines of acceptable quality.
To increase access to safe, effective, and affordable essential medicines of acceptable quality, and protect public health, the Southern African Development Community (SADC) through its African Medicines Regulatory Harmonization (AMRH) initiative sought to implement effective medicines regulatory systems within the SADC region.
The SADC consists of 16 member states (Angola, Botswana, Union of Comoros, Democratic Republic of Congo (DRC), Lesotho, Madagascar, Malawi, Mauritius, Mozambique, Namibia, Seychelles, South Africa, eSwatini, Tanzania, Zambia, and Zimbabwe).
In 1999, the SADC Council of Ministers approved the harmonization of medicines regulation in the region in line with Article 29 of the Protocol on Health. This gave birth to the AMRH initiative (SADC MRH project) which focused on building effective medicines regulatory systems within the SADC region. The SADC Member States were at varying levels of development in terms of organizing and sharing regulatory information.
To achieve this goal, there was a need for the SADC MRH to put in place a system for sharing information to enhance the gains of medicines regulatory harmonization.
Bewsys was contracted by the World Bank Group to develop system requirements for a web-based, Regulatory Information Management System (R-IMS) and to scope the activities needed to put the R-IMS in place. The team conducted a comparative study of existing R-IMS and Infrastructure to identify specific technical and user requirements needed to establish the most efficient R-IMS for the region.
During the study, the team worked in close collaboration with the National Medicines Regulatory Authorities (NMRAs) in all the member states to enable the team to produce a detailed roadmap implementation plan for the suggested solution.
The Bewsys consulting team considered the online and real-time availability of medicine regulation information in the process of generating recommendations for the best-fit R-IMS. The feasibility report that was prepared highlighted a proposed solution that will be built on the existing platforms and made room for compatibility and workflow processing.
The proposed solution suggested to the SADC MRH by the Bewsys consulting team provided a structured roadmap for the SADC region to develop and implement an integrated IMS to enhance decision making and information sharing within the AMRH initiative.
This proposed solution sets the tone for policy dialogue and frameworks to create the much-needed harmonised medicine regulatory systems. This is a step in achieving sustainable access to safe and quality medicines across the SADC region.