Zambia

The Zambia Medicines Regulatory Authority (ZAMRA) is the primary national regulatory body responsible for overseeing the registration, quality control, and post-market surveillance of health products in Zambia, including pharmaceuticals, medical devices, diagnostics, and increasingly digital health solutions. ZAMRA was established under the Medicines and Allied Substances Act No. 3 of 2013, which replaced the earlier Pharmaceutical Act and expanded the regulatory mandate to cover a broader range of health products. All health products intended for sale or distribution in Zambia must be registered with ZAMRA prior to market entry, with applications assessed for safety, quality, and efficacy based on submitted technical dossiers.

ZAMRA accepts dossiers prepared in accordance with the Common Technical Document (CTD) format, and aligns its review processes with regional frameworks under the African Medicines Regulatory Harmonization (AMRH) initiative and the African Union Development Agency (AUDA-NEPAD). Applicants are required to appoint a local authorized representative or registered entity in Zambia to facilitate regulatory submissions and post-market obligations. ZAMRA has introduced a tiered review pathway that includes provisions for expedited review of products that have received prior approval from recognized stringent regulatory authorities (SRAs) such as the US FDA, EMA, or WHO prequalification. Recent reforms have focused on strengthening post-market surveillance, improving transparency in registration timelines, and expanding the regulatory framework for in vitro diagnostics and digital health tools in response to growing demand.

Public procurement of health products in Zambia is primarily coordinated through the Ministry of Health (MoH), which sets national health commodity needs and priorities in alignment with the National Health Strategic Plan. The Zambia Medicines and Medical Supplies Agency (ZAMMSA), established under the Zambia Medicines and Medical Supplies Agency Act No. 8 of 2019, serves as the central procurement and supply chain management entity for public sector health commodities, replacing the former Medical Stores Limited. ZAMMSA manages tendering, warehousing, and distribution of medicines, diagnostics, and medical devices to government health facilities across the country. Procurement is governed by the Public Procurement Act and overseen by the Zambia Public Procurement Authority (ZPPA), which requires open competitive tendering for contracts above specified thresholds, with registration of suppliers as a mandatory prerequisite.

Zambia's health commodity landscape is heavily supported by international donor and financing agencies, including the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID through its global health programs, UNICEF, and Gavi, the Vaccine Alliance, which collectively fund a significant proportion of essential medicines, vaccines, diagnostics, and health supplies. Products procured through these channels must typically meet WHO prequalification standards or SRA approval requirements, and procurement often occurs via international competitive bidding or through pre-approved supplier rosters. The private sector, including faith-based health networks such as the Churches Health Association of Zambia (CHAZ), also plays a notable role in health product distribution. Zambia has expressed interest in promoting local manufacturing through regional policy frameworks such as the African Union Pharmaceutical Manufacturing Plan for Africa, though domestic manufacturing capacity remains limited, and most health products are currently imported.