Zambia

The Zambia Medicines Regulatory Authority (ZAMRA) is the primary national regulatory authority responsible for the registration and oversight of medicines, medical devices, diagnostics, and related health products in Zambia. ZAMRA was established under the Medicines and Allied Substances Act No. 3 of 2013, which replaced the previous Pharmaceutical Act and broadened the regulatory mandate to include medical devices and diagnostics alongside pharmaceuticals. All health products intended for sale or distribution in Zambia must be registered with ZAMRA prior to market entry. The registration process involves submission of a product dossier, laboratory testing, and inspection of manufacturing facilities, with ZAMRA conducting technical evaluations of quality, safety, and efficacy before granting market authorization.

ZAMRA accepts dossiers prepared in the Common Technical Document (CTD) format, broadly aligned with ICH guidelines, and also recognizes submissions formatted according to the African Common Technical Document (ACTD) as promoted by the African Medicines Regulatory Harmonisation (AMRH) initiative. Applicants are required to appoint a local authorized representative or agent registered in Zambia to liaise with ZAMRA throughout the approval process. ZAMRA participates in the African Union Development Agency-NEPAD (AUDA-NEPAD) harmonization frameworks and has progressively adopted reliance pathways, whereby positive decisions from stringent regulatory authorities such as the EMA, US FDA, or WHO Prequalification can expedite local review. Recent reforms have focused on strengthening post-market surveillance, implementing risk-based classification for medical devices, and digitalizing the product registration portal to improve transparency and reduce administrative backlogs.

Public procurement of health products in Zambia is primarily coordinated through the Ministry of Health (MOH) in conjunction with the Zambia Medicines and Medical Supplies Agency (ZAMMSA), which serves as the central procurement and distribution body for medicines, medical devices, diagnostics, and other health commodities in the public sector. ZAMMSA manages warehousing, quantification, and last-mile delivery to public health facilities across the country. Large-scale public procurement is governed by the Public Procurement Act and overseen by the Zambia Public Procurement Authority (ZPPA), which sets procedural rules for competitive tendering, framework agreements, and direct procurement under emergency conditions. Suppliers wishing to participate in government tenders must be registered with ZPPA and comply with its bidding and contract management requirements.

Donor-funded procurement constitutes a significant share of Zambia's health product supply, with major international partners including the Global Fund to Fight AIDS, Tuberculosis and Malaria, PEPFAR through USAID, UNICEF, and Gavi, the Vaccine Alliance, collectively financing a substantial proportion of essential medicines, vaccines, diagnostics, and medical devices. These procurement channels often operate through international procurement agents such as UNICEF Supply Division or the Global Fund's pooled procurement mechanisms, and products supplied under these programs are generally required to meet WHO Prequalification or equivalent stringent regulatory authority standards rather than local ZAMRA registration in the first instance. The private sector, encompassing retail pharmacies, private hospitals, and mission health facilities, procures independently from licensed importers and distributors. Zambia has indicated policy interest in supporting local and regional manufacturing, consistent with the African Union's Pharmaceutical Manufacturing Plan for Africa, though a formal local manufacturing preference policy with defined price or margin advantages has not yet been fully institutionalized in public procurement regulations.