Following formal assessment by WHO, Zimbabwe has achieved maturity level 3 (ML 3) in WHO’s classification of regulatory authorities for regulation of medicines.
The WHO assessment of regulatory authorities is based on the Global Benchmarking Tool, which checks regulatory functions against a set of more than 260 indicators beginning with ML1 describing the existence of some elements of a regulatory system. Maturity level 3 confirms a stable, well-functioning and integrated regulatory system is in place. The highest level, maturity level 4, is achieved by a regulatory system operating at an advanced level of performance and with continuous improvement.
The benchmarking of the National Regulatory System of Zimbabwe, represented by the Medicines Control Authority of Zimbabwe (MCAZ) and other relevant regulatory institutions of Zimbabwe, was first conducted in 2021 and finalized in May 2024 in close collaboration with the WHO Regional Office for Africa.
“This is an important step forward by Zimbabwe, which reflects commitment to strengthening health systems and regulatory frameworks to increase access to quality medicines and medical supplies, and to help accelerate progress towards universal health coverage,” said Dr Matshidiso Moeti, WHO Regional Director for Africa.
WHO’S global benchmarking is part of the WHO programme for regulatory system strengthening and covers core regulatory functions such as product authorization, testing of products, market surveillance and the ability to detect adverse events to establish their level of maturity and functionality. Regulatory authorities that reach maturity levels 3 and 4 are considered eligible for inclusion among WHO-listed Authorities, after additional evaluation of their performance.
“This represents a significant milestone for Zimbabwe, as MCAZ has reached the level of a regulatory system operating as a stable, well-functioning and integrated regulatory system for medicine regulation,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “This achievement is the result of investment by the Government of Zimbabwe in the strengthening of its regulatory system and will also contribute to future operationalization of the African Medicine Agency (AMA).”
Regulation of medical products is extremely important for all health systems and for access to quality vaccines, medicines and other health products. Apart from ensuring the quality, safety and efficacy of medical products, regulatory authorities that function well also perform critical functions such as efficient authorization of products and drug safety monitoring.
