Medicines Control Authority of Zimbabwe Reaches WHO Benchmark Tool Maturity Level 3
By Desire Tshuma
Zimbabwe’s regulatory system has attained Maturity Level 3 for the regulation of medicines and vaccines, the Medicines Control Authority of Zimbabwe (MCAZ) has announced. This was after a thorough assessment and the successful implementation of critical recommendations by the World Health Organization (WHO).
Zimbabwe now joins of only six African countries to have reached this significant milestone. By achieving GBT ML 3 signifies that MCAZ has developed a stable, well functional and integrated regulatory system, ensuring the quality, safety and efficacy of medicines and vaccines registered by the authourity. The status 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 has been a strategic objective for us as a regulator, reflecting our dedication on 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,” Richard Rukwata MCAZ director-general said on Monday.
He said that MCAZ has a rich heritage of accolades in the medical products regulatory space, starting with ISO 1705 accreditation for the laboratory in the year 2010. Following that the MCAZ laboratory became one of the first laboratories on the African continent to be pre-qualified by the WHO in 2014 leading to MCAZ undertaking analysis of medicines for many other countries on the continent including DRC, Angola, Djibouti, Mali, Zambia, Namibia, Lesotho and Burkina Faso, among others.
In 2015, MCAZ was designated as a Center of Regulatory Excellence by AUDA-NEPAD in the field of clinical trials and marketing authorisation. It further acquired ISO 9001:2015 in 2018 and ISO 17020 for its inspectorate in 2020.
“I express gratitude for the support and collaboration from stakeholders including the Ministry of Health and Child Care, local industry players and the public of Zimbabwe for their invaluable contributions to this achievement ” said Mr Rukwata.