MCAZ (Zimbabwe)
MCAZ (Medicines Control Authority of Zimbabwe) is the national regulator for human and veterinary medicines, biologicals, medical devices, IVDs, allied substances and clinical trials — established under the Medicines and Allied Substances Control Act (Chapter 15:03).
The Medicines Control Authority of Zimbabwe (MCAZ) is Zimbabwe's national regulator for human and veterinary medicines, biologicals, vaccines, medical devices, IVDs, allied substances, cosmetics and clinical trials. MCAZ operates under the Medicines and Allied Substances Control Act (Chapter 15:03) and reports to the Ministry of Health and Child Care from its Harare headquarters with a laboratory in Msasa.
Zimbabwe participates in the SADC-ZAZIBONA collaborative medicines registration procedure — a joint assessment scheme with Zambia, Zimbabwe, Botswana, Namibia and additional SADC member states that produces a common assessment report recognised across participants subject to national approval. MCAZ also operates reliance pathways for approvals from FDA, EMA, MHRA, Health Canada, TGA, Swissmedic and PMDA. Generics and biosimilars follow CTD-aligned review; medical devices follow a risk-classified pathway aligned to IMDRF principles.
GMP inspections of overseas manufacturers are risk-based; PIC/S / EU / FDA GMP certificates support desk review, while biologicals, sterile products and high-risk devices attract on-site inspection. MCAZ is a PIC/S member since 2020, aligning its inspection regime with international norms — one of only a handful of African medicines regulators with PIC/S membership. V5 Ultimate maps directly onto MCAZ expectations — bound e-signatures, ALCOA+ batch records, deviation/CAPA workflow, and a per-country dossier pack — with the paired guide at /glossary/zimbabwe-mcaz.
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