A critical AU Model Law aimed at harmonizing medical products regulatory systems in Africa was endorsed by African Heads of State and Government at the January 2016 AU Summit in Addis Ababa, Ethiopia. The AU Model Law will contribute towards accelerate the regulation of safe, quality and affordable medical products and technologies in Namibia.

Following a successful ZAZIBONA Assessors meetings in 2015, a total of 103 products were reviewed. As a result, the ZAZIBONA Heads of Agencies (HoA) recommended a total of 28 products for registration within SADC member states. As a participating member, Namibia successfully registered a total of 13 products and remains committed to the harmonization of medical products registration. The ZAZIBONA HoA also recommended 14 products for non-registration while 61 are pending. The ZAZIBONA scheme is part of the SADC Framework for Regulatory Harmonization and was endorsed by the SADC Regulators Forum. A further four (4) ZAZIBONA Assessors meetings will be held in 2016.

 

Programme Reference
African Medicines Regulatory Harmonisation (AMRH)
Country selection
Namibia
oldmapid
5533
Key Results
A scheme for collaboration between Zambia, Zimbabwe, Botswana and Namibia (ZAZIBONA) which started in 2013, resulted in joint assessments and inspections of manufacturing sites. Subsequently, SADC Regulators Forum endorsed the implementation of AMRH Programme using the ZAZIBONA approach. To date, 105 products have been reviewed under ZAZIBONA Scheme, with subsequent registration of 13 products in Namibia. This has been achieved through a collaborative framework between SADC Secretariat, NEPAD, World Bank, and WHO
The continent’s first Model Law on Medical Products Regulation was endorsed by African Leaders in January 2016 to improve access to quality and safe drugs and as well fight the circulation of fake medical products on the continent
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