Zimbabwe’s medicines regulator achieves maturity level 3 milestone
THE Medicines Control Authority of Zimbabwe (MCAZ) has achieved a significant milestone by announcing that the country’s regulatory system for medicines and vaccines has reached Maturity Level 3 (ML 3).
The accomplishment highlights Zimbabwe’s dedication to ensuring the safety, effectiveness, and quality of healthcare products.
The achievement recognises the country’s progress in strengthening its regulatory framework, enhancing oversight, and improving quality control, ultimately benefiting healthcare professionals, patients, and the industry as a whole.
The development follows a comprehensive assessment and the successful implementation of critical recommendations by the World Health Organization (WHO).
Zimbabwe joins a select group of six African nations that have reached this milestone, including the United Republic of Tanzania in 2018, Ghana in 2020, the Federal Republic of Nigeria, Republic of South Africa and the Arab Republic of Egypt in 2022.
Maturity Level 1 means that there is no formal approach or some elements of the regulatory system exists, Maturity Level 2 indicates the existence of a reactive approach or an evolving regulatory system that partially performs essential regulatory functions.
Maturity Level 3 signifies a stable, well-functioning and integrated regulatory system.
Maturity Level 4, which is the highest level under this framework, signifies a regulatory system operating at an advanced level of performance and continuous improvement.
Achieving Global Benchmarking Tool (GBT) ML 3 signifies that MCAZ has developed a stable, well-functioning, and integrated regulatory system, ensuring the quality, safety, and efficacy of medicines and vaccines registered by the Authority.
In a statement, MCAZ Director -General Mr Richard Rukwata said that MCAZ’s achievement of ML3 underscores Zimbabwe’s commitment to maintaining the highest standards in public health protection through rigorous regulatory oversight.
“The attainment of GBT ML 3 has been a strategic objective for us as a regulator, reflecting our dedication to safeguarding public health. This milestone demonstrates our 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,” said Mr Rukwata.
Mr Rukwata said MCAZ has a culture of excellence which has been in existence over a long period of time and the current achievement solidifies this culture by being another feather in the Authority’s cap and demonstration that MCAZ takes its mandate to protect public and animal health very seriously.
“ MCAZ is particularly very proud of the fact that it achieved this milestone without external help and purely of its own limited resources. This further goes to show the Authority’s commitment to delivering on its mandate regardless of the obstacles it might face,” he said.
Mr Rukwata further expressed gratitude for the support and collaboration from stakeholders, including the Ministry of Health and Child Care, local industry players, and the Zimbabwean public noting their invaluable contributions to this achievement.
“The journey to ML 3 involved extensive reviews and enhancements of regulatory policies, procedures, and practices. Key focus areas included strengthening pharmacovigilance, ensuring robust market surveillance, and enhancing regulatory inspections and enforcement mechanisms,” added Mr Rukwata.-chornicle
