The Medicines Control Authority of Zimbabwe has commenced a high level assessment under the World Health Organization Global Benchmarking Tool, as the country pushes toward achieving Maturity Level Four, the highest standard for national medicines regulatory systems.
The mission, running from 27 April to 1 May 2026 in Harare, marks a critical step in Zimbabwe’s effort to strengthen oversight of medicines and allied substances in line with international best practice.
The opening session brought together officials from the Ministry of Health and Child Care, the Attorney General’s Office, MCAZ board and management, the WHO Country Representative and technical benchmarking experts, alongside key stakeholders in the national health regulatory system.
Proceedings outlined the scope of the assessment, with the WHO framework focusing on evaluating the effectiveness, efficiency and transparency of Zimbabwe’s regulatory functions.
MCAZ presented its operational systems across core regulatory areas, including marketing authorisation, pharmacovigilance, market control, licensing of establishments, regulatory inspections, laboratory testing and clinical trials oversight.
Following the official launch, WHO experts initiated technical assessments through document reviews and structured interviews with MCAZ personnel, aimed at measuring compliance with global standards and identifying areas requiring further strengthening.
The mission follows Zimbabwe’s attainment of WHO Maturity Level Three status in 2024, a benchmark that signified a stable and well functioning regulatory system. Progressing to Level Four would position Zimbabwe among a select group of countries with advanced and internationally recognised regulatory frameworks.
Officials say the outcome of the ongoing benchmarking process will inform an updated Institutional Development Plan, providing a roadmap for closing gaps and consolidating gains within the regulatory system.
The development carries significant implications for public health, pharmaceutical trade and investment, as stronger regulatory credibility enhances confidence in the safety, quality and efficacy of medicines circulating in the country.
MCAZ reaffirmed its commitment to maintaining high regulatory standards, emphasizing its mandate to safeguard public and animal health while aligning Zimbabwe’s systems with evolving global requirements.
The move signals Zimbabwe’s continued investment in institutional capacity and regulatory excellence, with potential to strengthen its position within regional and international pharmaceutical value chains.
