Zimbabwe

The Medicines Control Authority of Zimbabwe (MCAZ) is the primary national regulatory authority responsible for the registration, control, and quality assurance 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 associated regulations, which govern the approval, importation, distribution, and post-market surveillance of all health products. The general approval process requires manufacturers or their local representatives to submit a registration dossier to MCAZ, which then conducts a technical evaluation covering quality, safety, and efficacy before granting market authorization. Products must be registered prior to importation or sale, and MCAZ also maintains oversight of clinical trials, pharmacovigilance, and advertising standards for health products.

Key submission requirements include the mandatory appointment of a registered local representative or agent who is responsible for liaising with MCAZ on behalf of foreign manufacturers. Dossier submissions are generally expected to follow the Common Technical Document (CTD) format, and MCAZ increasingly recognizes data from stringent regulatory authorities (SRAs) such as the US FDA, EMA, and WHO Prequalification Programme to facilitate expedited or abridged review pathways. MCAZ has undertaken notable reforms in recent years, including participation in the African Medicines Regulatory Harmonization (AMRH) initiative under the African Union Development Agency (AUDA-NEPAD), alignment with SADC harmonization frameworks, and efforts to introduce risk-based classification systems for medical devices and diagnostics. Fee structures and timelines can vary depending on product category and the review pathway used, with abridged processes available for WHO-prequalified or SRA-approved products.

Public sector health procurement in Zimbabwe is primarily coordinated through the Ministry of Health and Child Care (MoHCC), which sets national health policies and defines essential medicines and health products lists in alignment with the Zimbabwe Essential Medicines List (ZEML). The National Pharmaceutical Company of Zimbabwe (NatPharm) serves as the central procurement and distribution agency for public health commodities, managing warehousing and logistics for government health facilities across the country. Procurement decisions at the national level are subject to the Public Procurement and Disposal of Public Assets Act (Chapter 22:23), overseen by the Public Procurement and Disposal of Public Assets Authority (PPDPA), which mandates competitive tendering processes for government contracts. Health facilities, provincial medical offices, and central hospitals may also conduct some decentralized procurement within approved frameworks, though the majority of essential health product procurement flows through NatPharm.

The private sector in Zimbabwe operates through independent pharmaceutical wholesalers, distributors, and retail pharmacies, representing a significant parallel channel for health product access, particularly in urban centers. Donor-funded procurement plays a critical and substantial role in supplementing public sector supply, with major international partners including the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID through mechanisms such as PEPFAR and the global health supply chain programs, UNICEF, and the World Health Organization providing significant volumes of medicines, diagnostics, and medical devices directly or through NatPharm. Gavi, the Vaccine Alliance, supports immunization supply chains for vaccines. Local manufacturing remains limited, though government policy expressed through the MoHCC and NatPharm frameworks encourages support for locally manufactured and SADC-sourced products where quality and price conditions are competitive, in line with broader industrialization goals under the national development agenda.