MCAZ attains WHO Benchmarking Tool Maturity Level 3

Harare, (New Ziana) –The Medicines Control Authority of Zimbabwe (MCAZ) regulatory system has added a feather with the attainment of the World Health Organisation (WHO) Benchmarking Tool Maturity Level 3 (GBT ML3).

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 that it registers.

It underscores the country’s commitment to maintaining the highest standards in public health protection through rigorous regulatory oversight.

MCAZ director general Richard Rukwata said on Monday achievement of (ML 3) for the regulation of medicines and vaccines (non-producing) follows a comprehensive assessment and the successful implementation of critical recommendations by the WHO, allowing the country to join six African countries to have reached the same milestone.

These include Tanzania in 2018, Ghana (2020), Nigeria, South Africa and Egypt in 2022.

ML 1 means that no formal or some elements of regulatory system exist, ML 2 indicates the existence of a reactive approach or an evolving regulatory system that partially performs essential regulatory functions, while ML 3 signifies a stable, well-functioning and integrated regulatory system.

The highest level under this framework is M 4, signifying a regulatory system operating at an advanced level of performance and continuous improvement.

“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,” said Rukwata.

He said the MCAZ has a rich heritage of accolades in the medical products regulatory space, starting with ISO 17025 accreditation for its laboratory in 2010, which became the first on the African continent to be prequalified by WHO in 2014.

This enabled Zimbabwe to undertake analysis of medicines for other countries including the DRC, Angola, Djibouti, Mali, Zambia, Nigeria, Lesotho, Burkina Faso, Congo Brazzaville, Botswana, Sudan and South Sudan amongst others, with the prequalification status renewed this year.

In 2015 MCAZ was designated as a Centre of Regulatory Excellence by the African Union technical and development agency AUDA-NEPAD in the field of clinical trials and marketing authorisation, 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,” said Rukwata.

He said the MCAZ is proud of attaining the achievement using its own limited resources without external assistance.

“The journey to ML 3 involved extensive reviews and enhancements of regulatory policies, procedures, and practices,” said Rukwata.

“Key focus areas included strengthening pharmacovigilance, ensuring robust market surveillance, and enhancing regulatory inspections and enforcement mechanisms.”

MCAZ is a statutory body established by an Act of Parliament and oversees the Medicines and Allied Substances Control Act (MASCA) and is the successor of the Drugs Control Council (DCC) and the Zimbabwe Regional Drug Control Laboratory (ZRDCL).

New Ziana