By Kuda Pembere
The Medicines Control Authority of Zimbabwe (MCAZ) is on the cusp of attaining Maturity Level 4 under the World Health Organization’s Global Benchmarking Tool (GBT), with only a few final steps remaining.
This was revealed by MCAZ Director General Mr. Richard Rukwata during the Authority’s 7th Annual General Meeting held in Harare on Friday.
Among the accolades MCAZ has earned, Rukwata highlighted the GBT as a significant milestone. He described it as the first intercontinental benchmark that allows every agency to be measured by the same standard.
It doesn’t matter whether you are the United States FDA, the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, the South African Health Products Regulatory Authority, the Botswana Medicines Regulatory Authority, ourselves, our neighbors, Zambia Medicines Regulatory Authority (ZAMRA) — it doesn’t matter,” he said.
“Anyone and everyone can step up to the same platform and be measured by the same standard. What this means is we have here an opportunity to create a world-class institution in a country that is often vilified by people who have never actually been here.”
Rukwata expressed pride in Zimbabwe’s leadership in pursuing the GBT journey.
“I’m always intrigued when some people come from Europe and, from what they’ve heard about Zimbabwe, they think they’ll be walking in the streets and see people starving, dying — but it’s never really the case. We have our challenges, right, as every other country. But the truth of the matter is, wherever we are, in our little corner, we can always make the best of ourselves.
“So at MCAZ, we jumped at this opportunity. From 2021, it was not easy, and we’re very, very proud of this achievement. And I will say this again and again — we’re very proud because we did it ourselves. And when I say ourselves, I’m not talking about MCAZ, I’m talking about Zimbabwe.”
He also noted that the MCAZ laboratory has retained its WHO prequalification status.
“In 2024, our lab analyzed 959 samples. And they retained their WHO prequalification status, which makes them, I think, one of three on the African continent that are prequalified, in addition to being Maturity Level 3. In fact, our lab is a Maturity Level 4 laboratory because the WHO says if you are prequalified, then you are a Maturity Level 4 facility.
“We are just waiting for some of these issues to be confirmed. Our micro lab retained ISO 17025, and the same with our medical devices lab. A lot of energy and resources have gone towards ICT and digital transformation,” Rukwata said.
He clarified that achieving Maturity Level 4 is not about distancing the Authority from the public or industry.
“And I will say that we set out a goal to attain Maturity Level 4 by the end of this year. What does it mean? Again, every time we talk about maturity levels, there are some amongst us who are afraid of what it means.
“It doesn’t mean that MCAZ will be standing aloof, far-divorced from its industry, far-divorced from the people that it aims to serve, simply so that we can wear an accolade that says, ah, we are Maturity Level 4.
“It basically just means more of the same: transparency, accountability, effectiveness, and efficiency, so that we become the agency that was envisioned by our legislature, an agency that serves its purpose very well for the betterment of life for all Zimbabweans.”
According to Rukwata, MCAZ’s internal self-assessment placed them at 99.8 percent compliance with the GBT, just shy of the 100 percent required for Maturity Level 4.
“And I’m very happy to say, from our own self-assessment, our score at GBT compliance — because the compliance tool, it’s very simple in essence — it is a scorecard from 1 percent to 100 percent. When you get to 100 percent, you are Maturity Level 4. By our own assessment, we are now at 99.8 percent. We only have two automation projects that we are working on for us to get to Maturity Level 4.
“And we have already invited WHO in July 2025 to come for that assessment. So we look forward to attaining that accolade in 2026. But we are not waiting to have a crown placed on our heads,” he said.
