Zambia

The Zambia Medicines Regulatory Authority (ZAMRA) is the primary national regulatory body 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 provides the legal framework for product registration, licensing of manufacturers and distributors, post-market surveillance, and pharmacovigilance. All health products intended for the Zambian market must undergo a formal registration process, which includes a scientific dossier review, product evaluation, and where applicable, facility inspection. ZAMRA also collaborates with regional bodies such as the African Medicines Regulatory Harmonisation (AMRH) initiative and is aligned with efforts under the African Union Development Agency (AUDA-NEPAD) to strengthen regulatory capacity across the continent.

Applicants seeking product registration in Zambia are required to submit a technical dossier broadly aligned with the Common Technical Document (CTD) format, and ZAMRA increasingly accepts dossiers evaluated by stringent regulatory authorities (SRAs) such as the EMA, US FDA, or WHO Prequalification Programme as a basis for expedited or abridged review. A locally registered agent or representative in Zambia is mandatory for all foreign manufacturers seeking product registration. Key submission requirements include proof of marketing authorization in the country of origin, certificates of pharmaceutical product (CPP), Good Manufacturing Practice (GMP) compliance documentation, labelling compliant with Zambian requirements, and safety and efficacy data. ZAMRA has been undertaking reforms to reduce review timelines, digitize submission processes, and expand its regulatory scope to include medical devices and in-vitro diagnostics more formally, reflecting a broader push toward comprehensive health product regulation.

Public procurement of health products in Zambia is centrally coordinated through the Ministry of Health (MOH), with the Medical Stores Limited (MSL) serving as the primary government parastatal responsible for the warehousing, distribution, and supply of medicines, medical devices, and other health commodities to public health facilities nationwide. National procurement processes are governed by the Public Procurement Act and overseen by the Zambia Public Procurement Authority (ZPPA), which sets the regulatory framework for tendering, supplier qualification, and contract management. The MOH issues periodic national tenders for essential medicines and health commodities, with MSL acting as the central procurement and logistics agent. Products procured through the public channel must be registered with ZAMRA, though temporary importation permits may be granted for essential commodities not yet formally registered in cases of public health need.

Zambia relies heavily on donor-funded procurement channels to supplement government health commodity financing. Major international partners including the Global Fund to Fight AIDS, Tuberculosis and Malaria, the United States Agency for International Development (USAID) through mechanisms such as PEPFAR and PMI, UNICEF, and Gavi, the Vaccine Alliance play a substantial role in financing and procuring health products for the Zambian market, often working directly with MSL or through approved international procurement agents. These donor channels frequently require products to meet WHO Prequalification or SRA approval standards, which can run parallel to or interact with ZAMRA registration requirements. Local manufacturing capacity in Zambia remains limited, though government policy increasingly emphasizes support for domestic pharmaceutical production as part of the broader African Medicines Manufacturing initiative, with preferences and incentives being explored to encourage local sourcing and reduce import dependency over the medium to long term.