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 Botswana.


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, Botswana successfully registered a total of 25 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.
 

 

 

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Key Results
Botswana has successfully registered 25 medical products through a collaborative medicines registration process between Southern African countries including Namibia, Zambia and Zimbabwe, named ZAZIBONA; a total number of 105 medical were registered in all participating countries
Botswana is expected to benefit from an African Union endorsed Model Law on Medical Products Regulation to improve access to quality and safe drugs and to fight the circulation of fake medical products on the continent