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. Zimbabwe has embraced and domesticated the AU Model Law and is already utilizing an adapted version.


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, Zimbabwe successfully registered a total of 20 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.


Zimbabwe also hosts a RECORE specialized in medicine registration and evaluation, quality assurance and/or quality control and clinical trials oversight called Medicines Control Authority of Zimbabwe (MCAZ). RCOREs are institutions with specific academic and technical regulatory science expertise and training capabilities capable of producing regulatory workforce in Africa.

 

Country selection
oldmapid
5548
Key Results
Zimbabwe has successfully registered two medical products through a collaborative medicines registration process between Southern African countries including Zambia, Botswana and Namibia, named ZAZIBONA; a total number of 105 medical were registered in all participating countries
Zimbabwe is among 12 other countries that have domesticated an adapted version of the continent’s first Model Law on Medical Products Regulation. The Model Law was endorsed by African Leaders in January 2016 with the aim to improve access to quality and safe drugs as well as fight the circulation of fake medical products on the continent
Zimbabwe hosts a Regional Centre of Regulatory Excellence (RECORE) specialising in medicine registration and evaluation, quality assurance, quality control and clinical trials oversight called Medicines Control Authority of Zimbabwe (MCAZ). RCOREs are institutions with specific academic and technical regulatory science expertise and training capabilities capable of producing regulatory workforce in Africa