MCAZ targets WHO Maturity Level 4 certification

Zimbabwe's medicines regulator, the Medicines Control Authority of Zimbabwe (MCAZ), has embarked on an ambitious journey to achieve Maturity Level 4 under the World Health Organization (WHO)'s Global Benchmarking Tool (GBT), a designation that would place the country among a distinguished group of nations with highly advanced regulatory systems.

Having reached Maturity Level 3 in June 2024, MCAZ is now internationally recognised as a stable and well-functioning authority. Maturity Level 4, the highest under WHO's benchmarking system, represents excellence in regulatory oversight, transparency, international collaboration, and technological sophistication.

Speaking at the 3rd Annual Joint Conference for Pharmaceutical Wholesalers and the Community Pharmacists Association in Harare, MCAZ's Head of Licensing and Enforcement, Ms. Caroline Samatanga, said the move to Level 4 reflects the Authority's commitment to building a trusted, transparent, and globally harmonised regulatory framework.

"We are pursuing Maturity Level 4 of the Global Benchmarking Tool as part of our institutional development plan," said Samatanga. "Once you are at Level 3, which we achieved last year, the next step is continuous improvement-meaning our regulatory system must operate at an advanced level. We must demonstrate transparency, data-driven decision-making, and global collaboration."

WHO's GBT assesses regulatory agencies across four levels, with most nations falling between Level 1 (basic) and Level 3 (well-functioning). Level 4 is rarely achieved and signals regulatory excellence with high levels of public accountability, risk-based decision-making, and digital integration.

Samatanga noted that reaching this top tier would not only boost Zimbabwe's standing in global health governance but also create new opportunities for local pharmaceutical producers.

"When you have an advanced regulator, it means you are in check with a good system," she explained. "This gives Zimbabwe the potential to export medicines across the region and build international confidence in our locally manufactured products."

MCAZ has already started reforms required to meet WHO's expectations, including digitalising dossier submissions and inspection systems, enhancing pharmacovigilance practices, and increasing public access to regulatory information.

"Transparency becomes key," said Samatanga. "We want patients and communities to know the standards that manufacturers and pharmacies are meeting. Reports will be publicly available, and stakeholders will understand exactly how we regulate."

The Authority is also entering into Memoranda of Understanding (MOUs) with peer regulators-a move in line with WHO's push for reliance-based frameworks. These agreements allow agencies to share technical data, inspections, and scientific assessments, reducing duplication and accelerating regulatory processes.

To prepare for final WHO evaluation, tentatively scheduled for July 2025, MCAZ will conduct internal assessments and invite peer reviews from countries that have already achieved Level 4. WHO technical advisors will guide Zimbabwe through the final stages of compliance.

The implications of this achievement are far-reaching. Reaching Maturity Level 4 would not only modernise Zimbabwe's regulatory processes but also improve access to affordable, quality-assured medicines, a critical component of Sustainable Development Goal 3, which promotes universal health coverage.

Zimbabwe is one of 11 African countries that have reached WHO Maturity Level 3, joining others like Ghana, Nigeria, South Africa, Rwanda, Senegal, and Tanzania. However, only a few countries globally have attained Maturity Level 4: Singapore (2022), South Korea (2022), and Saudi Arabia (2023).

For Zimbabwe, this push could unlock access to international donor-funded pharmaceutical programs, open export markets, and attract investment into the country's pharmaceutical sector.

"As we move towards Maturity Level 4, we are committing to a culture of continuous improvement and transparency," said Samatanga. "It's a journey that requires legal, technical, and institutional reforms, but it's a goal we are ready to achieve."

If successful, MCAZ's progress will signal Zimbabwe's emergence as a credible global player in the regulation of medicines and health products-a move that could improve public health outcomes and position the country as a regional hub for pharmaceutical manufacturing and oversight.