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Zimbabwe becomes 6th African nation to attain WHO maturity level 3 status

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By Tapiwa Svondo


The Medicines Control Authority of Zimbabwe has been recognized for achieving a maturity level 3 (ML 3) status in the World Health Organization’s classification of authorities for the regulation of medicines.

This achievement sees Zimbabwe being the 6th African state joining Tanzania which attained the status in 2018, Ghana in 2020, Nigeria, South Africa and Egypt in 2022.

This recognition comes after the WHO assessed Zimbabwe’s regulatory authority.

“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”, said WHO.

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 a 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).”

The MCAZ Director-General, Richard Rukwata, indicated that this achievement signifies that the Zimbabwe Medicine Authority is in safe hands.

“The attainment of GBT ML 3 has been a strategic objective for us as a regulator, reflecting our dedication to safeguarding public health.

This milestone demonstrates our capability to effectively regulate and monitor the safety, quality, and efficacy of medicines, vaccines, and medical devices in Zimbabwe.

“It assures the public and our partners that Zimbabwe’s regulatory framework meets international standards. I commend the MCAZ Board and all our staff for their relentless efforts and commitment to achieving this goal,” said Rukwata.

Rukwata emphasised that MCAZ has rich accolades in the medical products regulatory space.

“Starting with ISO 17025 Accreditation for the laboratory in the year 2010, following that the MCAZ laboratory became one of the first labs on the African continent to be prequalified by the WHO in 2014, leading to MCAZ undertaking analysis of medicines for many other countries on the African continent including the DRC, Angola, Djibouti, Mali, Zambia, Namibia, Lesotho, Burkina Faso, Congo Brazzaville, Botswana, Sudan and South Sudan amongst others. The prequalification status was renewed this year in 2024.

“Further, in 2015, MCAZ was designated as a Centre of Regulatory Excellence by AUDA-NEPAD in the field of clinical trials and marketing authorisation. MCAZ further acquired ISO 9001:2015 in 2018 and ISO 17020 for its inspection in 2020”, he added.