Regional medicine regulatory management system for the 16 Southern African Countries

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Impact Strategy Consulting
Angola, Botswana, Comoros, Democratic Republic of Congo, Eswatini, Lesotho, Madagascar, Malawi, Mauritius, Mozambique, Namibia, Seychelles, South Africa, United Republic Tanzania, Zambia and Zimbabwe
World Bank / SADC

Background‍: The Southern African Development Community (SADC) through its African Medicines Regulatory Harmonization (AMRH) initiative sought to implement effective medicines regulatory systems to increase access to safe and affordable medicines and protect public health. In 1999, the SADC Council of Ministers approved the harmonization of medicines regulation in the region. Since then, there has been the need for a system for sharing information to enhance the gains of medicines regulatory harmonization.

Solution‍: In 2018, Bewsys was contracted by the World Bank Group to develop requirements and to scope the activities required for hamrinosied medicine regulatory processes and information sharing. Bewsys collaborated with the National Medicines Regulatory Authorities to produce a digitalisation strategy, implementation plan and systems requirements to set-up an integrated regional medicine regulatory system. 

Impact‍: The proposed solution, which sets the tone for policy dialogue and frameworks, 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 is a tep in achieving sustainable access to safe and quality medicines across the SADC region.

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