By Staff Reporter
The Medicines Control Authority of Zimbabwe (MCAZ) has been certified as a Maturity Level 3 (ML3) medicines and vaccines (non producing) regulator by the World Health Organization (WHO) making it the sixth African country to attain this level on the continent.
Zimbabwe joins 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 as the only countries that have attained the Level 3 benchmark.
After a comprehensive assessment and the successful implementation of critical recommendations by the World Health Organization (WHO), the Level 3 reflects a stable, well-functioning and integrated regulatory system is in place.
“The highest level, maturity level 4, is achieved by a regulatory system operating at an advanced level of performance and with continuous improvement,” WHO said.
The benchmarking of the National Regulatory System of Zimbabwe, represented by the Medicines Control Authority of Zimbabwe (MCAZ) and other relevant regulatory institutions of Zimbabwe, was first conducted in 2021 and finalized in May 2024 in close collaboration with the WHO Regional Office for Africa.
“This is an important step forward by Zimbabwe, which reflects commitment to strengthening health systems and regulatory frameworks to increase access to quality medicines and medical supplies, and to help accelerate progress towards universal health coverage,” said Dr Matshidiso Moeti, WHO Regional Director for Africa.
WHO’S global benchmarking is part of the WHO programme for regulatory system strengthening and covers core regulatory functions such as product authorization, testing of products, market surveillance and the ability to detect adverse events to establish their level of maturity and functionality. Regulatory authorities that reach maturity levels 3 and 4 are considered eligible for inclusion among WHO-listed Authorities, after additional evaluation of their performance.
“This represents a significant milestone for Zimbabwe, as MCAZ has reached the level of a regulatory system operating as a stable, well-functioning and integrated regulatory system for medicine regulation,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “This achievement is the result of investment by the Government of Zimbabwe in the strengthening of its regulatory system and will also contribute to future operationalization of the African Medicine Agency (AMA).”
These are 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 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,” said MCAZ director general Mr Richard Rukwata.
Mr. Rukwata 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 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,” Mr Rukwata said.
MCAZ boasts a heritage of accolades in the medical products regulatory space, starting with ISO 17025 Accreditation for the laboratory in the year 2010, following that the MCAZ laboratory became one of the first labs on the African continent to be prequalified by the WHO in 2014, leading to MCAZ undertaking analysis of medicines for many other countries on the African continent including the DRC, Angola, Djibouti, Mali, Zambia, Nigeria, Lesotho, Burkina Faso, Congo Brazzaville, Botswana, Sudan and South Sudan amongst others. The prequalification status was renewed this year in 2024.
“Further, in 2015, MCAZ was designated as a Centre of Regulatory Excellence by AUDA-NEPAD in the field of clinical trials and marketing authorisation. MCAZ further acquired ISO 9001:2015 in 2018 and ISO 17020 for its inspectorate in 2020.
“The above accolades demonstrate that MCAZ has a culture of excellence which has been in existence over a long period of time and this 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 the obstacles it might face,” Mr Rukwata said.
