By Dickson Bandera
After a landmark 2024, during which the Medicines Control Authority of Zimbabwe (MCAZ) achieved World Health Organization (WHO) Global Benchmarking Tool (GBT) Maturity Level 3 (ML3), the Authority has now set its sights on attaining Maturity Level 4.
Reaching ML3 in 2024 placed Zimbabwe among only eight African countries—alongside Egypt, Ghana, Nigeria, Rwanda, Senegal, South Africa, and Tanzania—that have achieved this level.
This next step highlights Zimbabwe’s commitment to further strengthening regulatory systems and reinforcing its position as a leading health regulator on the African continent.
The WHO GBT evaluates national regulatory authorities against over 250 indicators, assessing functionality, stability, and compliance with international standards. Maturity Level 3 reflects a stable, well-functioning, and integrated regulatory system, capable of managing risks, enforcing regulations, and ensuring quality-assured medicines reach the public.
Speaking at the Authority’s Annual General Meeting and Stakeholders Forum in Harare, MCAZ Chairperson Dr. Misheck Chiware described 2024 as a transformative year for regulatory and institutional strengthening that enhanced oversight of medicines, medical devices, and allied substances.
“Achieving Maturity Level 3 demonstrates that MCAZ operates as a stable, effective, and well-functioning regulatory authority,” Dr. Chiware said. “It reflects our ability to consistently ensure the safety, quality, and efficacy of health products, in line with international standards, and strengthens public confidence.”
In 2024, MCAZ made substantial progress in streamlining medicine registration, intensifying inspections, enforcing regulations, and enhancing post-market surveillance. These measures have improved public trust, increased access to safe medicines, and aligned with Zimbabwe’s National Development Strategy 1 (NDS1) priorities.
Governance improvements were also significant, with 96% adherence to corporate governance standards, operationalisation of Risk Management and Integrity Committees, and the onboarding of new board members, including public health expert Dr. R. Simbi.
MCAZ’s strategic initiatives in 2024 focused on digital transformation, stakeholder engagement, and regional regulatory harmonisation. The Authority led the ZAZIBONA collaborative initiative, reinforcing Zimbabwe’s role as a regulatory hub within the SADC region.
Looking ahead, Dr. Chiware emphasised MCAZ’s ambition to advance to WHO Maturity Level 4. This next milestone will further automate regulatory systems, enhance transparency, and strengthen public trust through efficient and ethical regulation.
“The dedication of MCAZ staff, together with continued collaboration from government, healthcare professionals, law enforcement, and development partners, was critical in achieving ML3 and will be instrumental as we pursue Level 4,” Dr. Chiware added.
With ML3 recognition, Zimbabwe now ranks among a growing list of African countries with globally benchmarked regulatory authorities, ensuring quality medicines, stronger health security, and regional leadership in health product regulation.
During the AGM, the Authority adopted the Chairperson’s Report, Director-General’s Report, Financial Report, Compliance Report, and Audit Report. The meeting also approved the continued engagement of the Auditor-General as external auditor and confirmed directors’ fees and allowances for non-executive directors.
MCAZ continues to play a crucial role in combating drug and substance abuse while actively engaging healthcare professionals, pharmaceutical companies, development partners, academics, civil society, and other stakeholders.
