By Hamu Madzedze
Online Journalist -Zimbabwe.
The Medicines Control Authority of Zimbabwe(MCAZ) has attained the World Health Organisation Maturity Level 3(ML3) for the regulation of medicines and vaccines following a comprehensive assessment and the successful implementation of critical recommendations by WHO.
The Maturity Level 3 signifies a stable well functioning and integrated regulatory system,ensuring the quality,safety , efficacy of medicines and vaccines registered by the regulatory authority.
With this achievement Zimbabwe joins Tanzania, Ghana, Nigeria, South Africa and Egypt who have also reached this milestone.
MCAZ Director General Richard Rukwata said being awarded the ML3 has been a strategic objective for them as a regulator and it reflects their 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.
Mr Rukwata added that this achievement also assures the public and their partners that Zimbabwe's regulatory framework meets international standards.
He said the journey to ML3 involved extensive reviews and enhancements of regulatory policies,procedures and practices.
"Key focus areas included strengthening pharmacovigilance,ensuring a robust market surveillance and enhancing regulatory inspections and enforcement mechanisms" said Mr Rukwata.
He also pointed out that MCAZ has a rich heritage of accolades in the medical products regulatory space beginning with ISO 17025 accreditation for the laboratory in the year 2010, in 2014 their laboratory became one of the first laboratories on the African continent to be prequalified by the WHO leading to the regulatory body undertaking analysis of medicines from countries such as the DRC ,Angola,Djibouti, Mali , Zambia, Nigeria,Lesotho,Burkina Faso,Congo Brazzaville,Botswana,Sudan and South Sudan.
"In 2015 MCAZ was designated as a Centre of Regulatory Excellence by AUDA-NEPAD in the field of clinical trials and marketing authorisation and in 2018 and 2020 the Medicines Control Authority of Zimbabwe attained ISO 9001:2015 and ISO 17020 for its inspectorate.
Mr Rukwata expressed gratitude for the unwavering support and collaboration from stakeholders including the Ministry of Health and Child Care,local industry players and the Zimbabwean community in ensuring the attainment of Maturity Level 3 was attainable.
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