WHO recognises Zim medicine safety standards

Philemon Jambaya

Assistant Editor

Zimbabwe has taken a significant step forward in ensuring the safety and quality of medicines available in the country. The Medicines Control Authority of Zimbabwe (MCAZ) has been recognized by the World Health Organization (WHO) for achieving a maturity level 3 (ML 3) status in its classification of authorities for the regulation of medicines.

This achievement places Zimbabwe among the top performers in Africa, joining Tanzania (2018), Ghana (2020), Nigeria, South Africa, and Egypt (all in 2022) in this prestigious category.

The WHO assessment is based on a comprehensive evaluation using the Global Benchmarking Tool (GBT). This tool assesses regulatory functions against over 260 indicators, with ML3 signifying a "stable, well-functioning and integrated regulatory system."

The journey to this achievement began in 2021 when the WHO Regional Office for Africa collaborated with Zimbabwe's National Regulatory System, represented by the MCAZ. The rigorous assessment process culminated in May 2024.

This achievement is a testament to Zimbabwe's commitment to strengthening its health systems and regulatory frameworks. Dr. Matshidiso Moeti, WHO Regional Director for Africa, highlighted the importance of this step, stating it "accelerates progress towards universal health coverage" by ensuring access to quality medicines and medical supplies.

Reaching ML3 opens doors for Zimbabwe. Regulatory authorities at this level are considered eligible for inclusion among WHO-listed Authorities, further solidifying their credibility. Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, emphasized this, stating it "represents a significant milestone" for Zimbabwe's robust regulatory system.

This achievement also paves the way for the future operationalization of the African Medicines Agency (AMA).

The MCAZ Director-General, Richard Rukwata, expressed his pride in this accomplishment. He emphasized that achieving GBT ML3 reflects the

Rukwata further highlighted MCAZ's rich history of excellence in the medical products regulatory space. He pointed to their achievements such as ISO certifications and prequalification by the WHO, showcasing their commitment to international standards.