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. All health products must be registered with the MCAZ before they can be legally marketed or distributed in Zimbabwe. The general approval process involves submission of a dossier to the MCAZ, followed by administrative screening, technical evaluation (including quality, safety, and efficacy review), and a final registration decision. The authority may conduct facility inspections and request additional data during the review process.

Applicants are generally required to appoint a local registered representative or agent based in Zimbabwe to liaise with the MCAZ and take regulatory responsibility for the product on the local market. Dossier submissions are expected to follow the Common Technical Document (CTD) format, and the MCAZ participates in regional harmonization initiatives under the African Union Development Agency (AUDA-NEPAD) and the Southern African Development Community (SADC) Medicines Regulatory Harmonization Programme, which has introduced provisions for reliance and recognition procedures based on approvals from stringent regulatory authorities (SRAs) or African reference agencies. Recent reforms have aimed at reducing timelines through expedited review pathways for priority medicines, diagnostics, and products that have received WHO prequalification or SRA approval, and the MCAZ has increasingly engaged with the African Medicines Regulatory Harmonisation (AMRH) initiative to streamline cross-border product registration.

Public procurement of health products in Zimbabwe is primarily coordinated through the Ministry of Health and Child Care (MoHCC), with the National Pharmaceutical Company of Zimbabwe (NatPharm) serving as the central procurement, warehousing, and distribution agency for medicines, medical devices, and diagnostics destined for public health facilities. Procurement processes are governed by the Public Procurement and Disposal of Public Assets Act (Chapter 22:23), overseen by the Public Procurement and Disposal of Public Assets Authority (PPDAA). Tenders for health commodities are generally issued at the national level, with NatPharm managing logistics and last-mile delivery to district and facility levels. Budget constraints and foreign currency shortages have historically affected procurement volumes and timelines in the public sector.

A significant proportion of health commodity procurement in Zimbabwe is supported by international donor and multilateral organizations, including the Global Fund to Fight AIDS, Tuberculosis and Malaria, PEPFAR through USAID implementing partners, UNICEF, and the World Health Organization (WHO). These channels often finance procurement of antiretrovirals, diagnostics, vaccines, and essential medicines through international competitive tendering, frequently requiring WHO prequalification or equivalent SRA approval as a condition of eligibility. The private sector operates through licensed importers, distributors, and pharmacy chains, and is generally more responsive but serves a smaller share of the population. Zimbabwe does not yet have a fully developed local pharmaceutical manufacturing base, though government policy documents and the SADC regional agenda express aspirations to promote local and regional manufacturing capacity, and preference for domestically produced goods may be applied where equivalent quality and supply can be demonstrated.