Zimbabwe elevates medicines regulation to global top tier

By Abigirl Tembo, Health Editor

ZIMBABWE has become the fourth country in the world to have its medicines regulator, the Medicines Control Authority of Zimbabwe (MCAZ), attain the World Health Organisation (WHO) Global Benchmarking Maturity Level 4 status, the highest international standard for medicines regulation.

The milestone was announced by WHO Regional Director for Africa, Dr Mohammed Yakub Janabi during a meeting with Health and Child Care Minister Dr Douglas Mombeshora on Wednesday, on the sidelines of the SADC Inter-Ministerial Meeting of Ministers of Finance and Health in Harare.

The WHO Global Benchmarking Tool assesses national medicines regulatory authorities against internationally recognised standards. Maturity Level 4 represents the highest level, indicating advanced systems that consistently ensure the quality, safety and efficacy of medical products while continuously strengthening regulatory performance.

The achievement builds on Zimbabwe’s earlier attainment of Maturity Level 3, which recognised a stable and well-functioning regulatory system capable of effectively overseeing medicines and related products.

Since then, MCAZ has strengthened its institutional capacity and regulatory systems, culminating in the attainment of the top-tier global status.

Announcing the development, Dr Janabi described it as a landmark achievement placing Zimbabwe among an exclusive group of countries with advanced regulatory systems.

“Zimbabwe’s achievement is extraordinary. It is only the fourth country in the world to attain the WHO Global Benchmarking Maturity Level 4 status, joining South Korea, Saudi Arabia and Singapore,” he said.

He said the recognition reflects strong confidence in Zimbabwe’s regulatory capacity and enhances its role in Africa’s pharmaceutical manufacturing and regulatory agenda.

“This accomplishment demonstrates regional leadership and inspires confidence in the quality, safety and effectiveness of medical products,” he said.

Dr Janabi, however, stressed the importance of sustaining the milestone through continuous improvement.

“Reaching Maturity Level 4 is one thing. Sustaining it is completely different, but we are going to work with you to ensure Zimbabwe maintains it,” he said.

The achievement is expected to boost investor confidence in Zimbabwe’s pharmaceutical sector, strengthen regional cooperation in medicines regulation, and support ambitions to position the country as a hub for quality-assured medical products in Africa.

Dr Janabi also commended Zimbabwe’s broader health sector reforms, including the recruitment of more than 14 000 health workers and continued investment in health infrastructure, saying these efforts demonstrate commitment to a resilient health system.

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