Zambia

The Zambia Medicines Regulatory Authority (ZAMRA) is the primary national regulatory authority responsible for the registration, control, and oversight of medicines, medical devices, diagnostics, and related health products in Zambia. ZAMRA operates under the Medicines and Allied Substances Act No. 3 of 2013, which replaced the earlier Pharmaceutical Act and significantly modernized the country's regulatory framework. All health products intended for sale or distribution in Zambia must be registered with ZAMRA prior to market entry, with applications assessed for quality, safety, and efficacy. The registration process involves submission of a dossier, product evaluation by ZAMRA technical reviewers, and where necessary, facility inspection or sample testing before a certificate of registration is granted.

ZAMRA accepts dossiers prepared in accordance with the Common Technical Document (CTD) format, and also recognizes submissions aligned with the African Union's African Common Technical Document (ACTD) guidelines, facilitating harmonization within the region. Applicants are generally required to appoint a local representative or agent registered in Zambia to act as the liaison with ZAMRA throughout the registration and post-market surveillance process. ZAMRA participates in the African Medicines Regulatory Harmonization (AMRH) initiative and has been progressively aligning its processes with those of the African Medicines Agency (AMA). Notable recent reforms include the introduction of an expedited review pathway for priority and essential health products, strengthened post-market surveillance mechanisms, and ongoing digitization of submission and tracking systems to reduce administrative bottlenecks.

Public sector 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), a statutory body established under the Zambia Medicines and Medical Supplies Agency Act No. 8 of 2019. ZAMMSA is responsible for the quantification, procurement, warehousing, and distribution of medicines and medical supplies to public health facilities across the country, replacing the former Medical Stores Limited. Procurement follows the Public Procurement Act and its associated regulations, with large-value tenders subject to review by the Zambia Public Procurement Authority (ZPPA). Framework agreements and long-term supply contracts are commonly used for essential medicines and consumables, with procurement decisions guided by the national Essential Medicines List (EML) and therapeutic guidelines issued by the MOH.

The private sector operates through licensed importers, distributors, and retail pharmacies regulated by ZAMRA, providing an independent channel for health product access particularly in urban centers. Zambia is heavily supported by international donor and financing mechanisms, including the Global Fund to Fight AIDS, Tuberculosis and Malaria, PEPFAR via USAID, UNICEF, and the World Health Organization (WHO), which collectively fund a substantial proportion of medicines and health commodities procured for the public system, particularly in HIV, malaria, and reproductive health programs. Gavi, the Vaccine Alliance, also plays a significant role in vaccine supply and cold-chain strengthening. While Zambia does not currently enforce a formal local manufacturing preference policy, the government has expressed strategic intent to promote domestic pharmaceutical production as part of regional industrialization initiatives under the African Union's Pharmaceutical Manufacturing Plan for Africa, and preferential considerations for locally manufactured products may be applied in future procurement frameworks.