The Medicines Control Authority of Zimbabwe (MCAZ) has announced that Zimbabwe’s regulatory framework has achieved Maturity Level 3 (ML 3) for the regulation of medicines and vaccines. Addressing the media today, MCAZ Director-General Mr. Richard Rukwata expressed his satisfaction with this achievement, stating, “The attainment of GBT ML 3 has been a strategic objective for us as a regulator, reflecting our dedication to safeguarding public health.”
Mr. Rukwata emphasized that this milestone demonstrates the authority’s capability to effectively 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. I commend the MCAZ Board and all our staff for their relentless efforts and commitment in achieving this goal,” Mr. Rukwata noted.
Highlighting MCAZ’s history of excellence in medical product regulation, Mr. Rukwata mentioned key milestones, including the ISO 17025 Accreditation of its laboratory in 2010 and the WHO prequalification of the MCAZ laboratory in 2014. This prequalification made it one of the first labs in Africa to achieve this status, enabling MCAZ to conduct medicine analyses for numerous African countries, including the DRC, Angola, and Zambia. The status was recently renewed in 2024.
Mr. Rukwata also underscored MCAZ’s commitment to its mandate of protecting public and animal health. “The Authority’s culture of excellence, demonstrated by these accolades, reinforces our commitment to delivering on our mandate despite challenges. Achieving this milestone solely through our own resources underscores our dedication to public health,” he said.
In a side interview, medical practitioner Ralph Mark applauded this milestone, stating, “This achievement follows a rigorous assessment and the successful implementation of crucial recommendations by the World Health Organization (WHO), positioning Zimbabwe among only six African nations to attain this esteemed status.” Mark also noted that the GBT ML 3 accreditation signifies that MCAZ has established a robust, efficient, and integrated regulatory system, ensuring the quality, safety, and efficacy of medicines and vaccines authorized by the Authority. “This accomplishment underscores Zimbabwe’s unwavering commitment to upholding the highest standards in public health protection through rigorous regulatory oversight,” he said.
Meanwhile, in 2015, MCAZ was designated as a Centre of Regulatory Excellence by AUDA-NEPAD in the field of clinical trials and marketing authorization. Subsequent achievements include ISO 9001:2015 in 2018 and ISO 17020 for its inspectorate in 2020, further solidifying MCAZ’s reputation as a centre of regulatory excellence.
