Zimbabwe Achieves Milestone in WHO's Classification of Regulatory Authorities for Medicines

By: Modupe Adeniyi. Freelance Health Reporter.

Map of Souther Africa showing the location of Zimbabwe. Click on image to enlarge.

MONDAY, JUNE 17, 2024. Zimbabwe has achieved a significant milestone in the regulation of medicines by attaining maturity level 3 (ML 3) in the World Health Organization's (WHO) classification of regulatory authorities. This achievement follows a formal assessment by the WHO which evaluates regulatory functions against a set of more than 260 indicators using the Global Benchmarking Tool.

Dr. Matshidiso Moeti, WHO Regional Director for Africa, noted, "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."

The benchmarking of Zimbabwe's National Regulatory System represented by the Medicines Control Authority of Zimbabwe (MCAZ) and other relevant regulatory institutions was conducted in collaboration with the WHO Regional Office for Africa. The process began in 2021 and was finalized in May 2024.

Reaching maturity level 3 confirms that Zimbabwe has established a stable, well-functioning and integrated regulatory system. This achievement is a testament to the government's investment in strengthening its regulatory framework and is expected to contribute to the future operationalization of the African Medicine Agency (AMA).

Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, emphasized the importance of this milestone, stating, "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."

The WHO's global benchmarking program is part of its efforts to strengthen regulatory systems worldwide. It covers core regulatory functions such as product authorization, product testing, market surveillance and the ability to detect adverse events. Regulatory authorities that achieve maturity levels 3 and 4 are considered eligible for inclusion among WHO-listed Authorities, subject to additional performance evaluations.

Effective regulation of medical products is crucial for all health systems and plays a vital role in ensuring access to quality vaccines, medicines and other health products. In addition to guaranteeing the quality, safety, and efficacy of medical products, well-functioning regulatory authorities perform critical functions such as efficient product authorization and drug safety monitoring.

Zimbabwe's achievement of maturity level 3 in the WHO's classification of regulatory authorities for medicines is a significant step forward in its commitment to strengthening its health system and ensuring access to quality medical products for its citizens.

Source: World Health Organization Newsroom.

Published: June 17, 2024

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