Zimbabwe

The Medicines Control Authority of Zimbabwe (MCAZ) is the primary national regulatory authority responsible for the registration, control, and oversight of medicines, medical devices, diagnostics, and related health products in Zimbabwe. It operates under the Medicines and Allied Substances Control Act (Chapter 15:03) and its subsequent amendments, which provide the legal framework governing product approval, post-market surveillance, pharmacovigilance, and enforcement. All health products intended for the Zimbabwean market must undergo a formal registration process with the MCAZ before they can be legally imported, manufactured, distributed, or sold. The approval process involves submission of a product dossier, evaluation by MCAZ technical committees, and, where necessary, laboratory testing and inspection of manufacturing facilities. The authority also collaborates with regional bodies such as the African Medicines Regulatory Harmonization (AMRH) initiative and the African Union Development Agency (AUDA-NEPAD) to align national standards with continental frameworks.

Applicants seeking product registration in Zimbabwe are required to appoint a local registered representative or agent who assumes regulatory responsibility for the product within the country. Dossiers are generally accepted in the Common Technical Document (CTD) format, and submissions aligned with ICH guidelines or ACTD standards are recognized, particularly for products already approved by stringent regulatory authorities (SRAs) such as the US FDA, EMA, or WHO Prequalification. The MCAZ may apply an abridged or expedited review pathway for products that hold SRA approval or WHO Prequalification status, which can significantly reduce review timelines. Recent reforms have focused on digitizing submission processes, strengthening post-market surveillance capacity, and expanding the scope of regulation to formally include medical devices and in-vitro diagnostics under clearer statutory frameworks, reflecting growing recognition of the need to regulate a broader range of health technologies beyond pharmaceuticals.

Public procurement of health products in Zimbabwe is primarily coordinated through the Ministry of Health and Child Care (MoHCC), which sets national health priorities and oversees the allocation of health commodities across the public sector. The National Pharmaceutical Company of Zimbabwe (NatPharm) serves as the central procurement and distribution agency for medicines and health supplies destined for government health facilities, acting as a strategic buffer stock holder and logistics manager. Procurement decisions at the national level are subject to the Public Procurement and Disposal of Public Assets Act (Chapter 22:23), administered by the Procurement Regulatory Authority of Zimbabwe (PRAZ), which governs tendering, supplier prequalification, and contract award processes. Large-scale tenders for health commodities are typically issued through competitive bidding processes, and suppliers must meet registration and compliance requirements set by both PRAZ and the MCAZ before participating.

The private sector in Zimbabwe operates through a network of pharmaceutical wholesalers, distributors, and retail pharmacies, with procurement driven by market dynamics and direct negotiations between suppliers and healthcare providers or pharmacy chains. Zimbabwe's health system is heavily supported by international donor and multilateral funding, with organizations such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, PEPFAR through USAID, UNICEF, Gavi the Vaccine Alliance, and the World Health Organization (WHO) playing significant roles in financing and supplying essential medicines, vaccines, diagnostics, and medical devices. Procurement under these donor-funded channels often follows the respective agency's own procurement rules and may require WHO Prequalification or SRA approval as a condition of eligibility. While Zimbabwe has expressed policy interest in promoting local manufacturing and import substitution to strengthen health security, domestic manufacturing capacity remains limited, and formal local preference policies in procurement are still developing, with NatPharm and the MoHCC beginning to explore frameworks that could incentivize local production of essential health commodities.