MCAZ Director-General Richard Rukwata at a press briefing in Harare
By George Swarei
Harare, 17 June 2024 – The Medicines Control Authority of Zimbabwe (MCAZ) announced today that it has attained Maturity Level 3 (ML 3) on the World Health Organization’s (WHO) Global Benchmarking Tool (GBT) for the regulation of medicines and vaccines. This achievement places Zimbabwe among only six African countries to reach this level, signifying a stable, well-functioning, and integrated regulatory system.
MCAZ Director-General Richard Rukwata stated that this milestone reflects the Authority’s dedication to public health protection. “Achieving GBT ML 3 demonstrates our capability to regulate and monitor the safety, quality, and efficacy of medicines, vaccines, and medical devices in Zimbabwe. It assures the public and our partners that Zimbabwe’s regulatory framework meets international standards,” Rukwata said.
The WHO’s comprehensive assessment and subsequent recognition of MCAZ’s efforts underscore Zimbabwe’s commitment to maintaining high public health standards through rigorous regulatory oversight. The journey to ML 3 involved significant enhancements in regulatory policies, procedures, and practices, particularly in pharmacovigilance, market surveillance, and regulatory inspections.
MCAZ has a history of regulatory excellence, beginning with its ISO 17025 Accreditation in 2010 and WHO prequalification of its laboratory in 2014, which was renewed in 2024. In 2015, the Authority was designated as a Centre of Regulatory Excellence by AUDA-NEPAD, and it acquired ISO 9001:2015 certification in 2018 and ISO 17020 in 2020.
Rukwata emphasized that MCAZ achieved this milestone independently, showcasing its commitment to its mandate despite resource constraints. He also thanked stakeholders, including the Ministry of Health and Child Care and local industry players, for their support and collaboration.
