By Michael Gwarisa
Zimbabwe’s medicines regulator, the Medicines Control Authority of Zimbabwe (MCAZ), is working towards achieving Maturity Level 4 under the World Health Organization’s Global Benchmarking Tool (GBT), a prestigious certification that would place the country among a select group of nations with advanced regulatory systems.
Having attained Maturity Level 3 in June 2024, MCAZ is now recognised by the WHO as a stable, well-functioning regulatory authority. The move to Maturity Level 4 signals the Authority’s ambition to continuously improve regulatory oversight, enhance transparency, and adopt globally accepted best practices in medicines regulation.
Speaking at the 3rd Annual Joint Conference for Pharmaceutical Wholesalers and the Community Pharmacists Association in Harare, MCAZ Head of Licensing and Enforcement Division, Ms. Caroline Samatanga, said the journey to Level 4 reflects the Authority’s strategic commitment to universal health coverage and quality medical products.
We are pursuing Maturity Level 4 of the Global Benchmarking Tool as part of our institutional development plan,” said Ms 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.”
According to the WHO’s Global Benchmarking Tool, regulatory systems are assessed across four maturity levels. Most countries fall between Level 1, which refers to basic or fragmented systems, and Level 3, which refers to stable and well-functioning systems. Maturity Level 4, however, represents the gold standard. It is defined by sustained performance, technological modernization, public accountability, and global integration.
MCAZ is now working to strengthen its internal systems through digitisation, increased transparency, and harmonisation with global regulatory authorities. Samatanga noted that the push to Level 4 would ultimately benefit local manufacturers and the health sector more broadly.
“When you have an advanced regulator, it means you are in check with a good system,” she said. “This gives Zimbabwe the potential to export medicines across the region and build international confidence in our locally manufactured products.”
The certification will also require MCAZ to modernise processes such as dossier submissions, inspections, and post-market surveillance. This includes moving from paper-based systems to electronic tools like eCTDs, adopting risk-based pharmacovigilance approaches, and ensuring public access to regulatory decisions and inspection reports.
“Transparency becomes key,” added 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.”
To achieve this, MCAZ has already begun signing Memoranda of Understanding (MOUs) with other regulatory authorities, a practice encouraged by the WHO as part of reliance frameworks. These agreements allow regulators to work collaboratively and share inspection reports and scientific assessments, minimising duplication and improving efficiency.
The Authority will also conduct internal assessments and seek peer review from regulators already operating at Level 4. WHO technical advisors are expected to support Zimbabwe in its final preparations before submission for official evaluation, tentatively scheduled for July 2025.
The move is expected to boost confidence in Zimbabwe’s pharmaceutical market and improve access to safe, effective, and quality-assured medicines in line with Sustainable Development Goal 3, which calls for universal health coverage and access to essential health services.
Zimbabwe joins a growing list of African nations striving to improve regulatory maturity. As of 2024, eleven African countries, including Ghana, South Africa, Nigeria, Rwanda, Senegal, and Tanzania, have reached WHO Maturity Level 3. However, only a handful of countries worldwide have achieved Level 4.
These include Singapore, which became the first to achieve Level 4 in February 2022, the Republic of Korea, which reached Level 4 in November 2022, and Saudi Arabia, which became the third global regulator to achieve Level 4 in October 2023.
Reaching this level will not only enhance Zimbabwe’s regulatory reputation globally but also improve patient safety, enable faster access to new medicines, and open opportunities for pharmaceutical trade within the region and beyond.
“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.”
