New African Nation Reaches WHO Maturity Level 3 In Medicines Regulation

Zimbabwe's National Regulatory Authority has achieved Maturity Level 3 in line with WHO's global benchmarking tool.
Maturity Level 3
Image credit: Medicines Control Authority of Zimbabwe

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Zimbabwe has become the sixth country to achieve Maturity Level 3 (ML3) in the World Health Organization’s (WHO) classification of regulatory authorities for the regulation of medicines. This places Zimbabwe alongside pharmaceutical leaders such as Egypt, Ghana, Nigeria, South Africa, and Tanzania.

This achievement reflects the diligent efforts of the Medicines Control Authority of Zimbabwe (MCAZ) to ensure access to safe, effective, and high-quality medical products for the protection of public health.

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The Significance of WHO Listing

Attaining ML3 status is significant as it positions Zimbabwe’s National Regulatory Authority (NRA) among the world’s reference regulators.

According to the WHO Global Benchmarking Tool, an ML3 classification signifies a stable, well-functioning, and integrated regulatory system, while ML4 denotes an advanced level of performance with continuous improvement.

Levels 3 and 4 are the benchmarks that many NRAs aspire to but often struggle to achieve.

Statements from Key WHO Officials

WHO Regional Director for Africa, Dr. Matshidiso Moeti, recognized Zimbabwe’s progress, stating, “This is an important step forward by Zimbabwe, reflecting 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.”

Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, also highlighted this milestone: “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 system for medicine regulation. This achievement is the result of investment by the Government of Zimbabwe in strengthening its regulatory system and will also contribute to the future operationalization of the African Medicine Agency (AMA).”

The Broader Impact on Africa

This accomplishment is a significant victory for Africa, a continent striving to transform its pharmaceutical sector by eliminating substandard and falsified medical products.

Zimbabwe, along with other ML3 countries, is setting a precedent for transformative change that promises to enhance public health in the long term.

Many other African nations are likely to pursue similar achievements in the near future, alongside initiatives such as establishing WHO-prequalified quality control laboratories to bolster the fight against counterfeit medicines through world-class quality control testing.

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