Mozambique

The primary national health regulatory authority in Mozambique is the Agência Reguladora de Medicamentos e Tecnologias de Saúde (ARMED), established under Decree No. 68/2020 to replace the former Departamento de Gestão de Medicamentos (DGM) within the Ministry of Health (Ministério da Saúde, MISAU). ARMED is responsible for the registration, licensing, inspection, and post-market surveillance of pharmaceuticals, medical devices, diagnostics, and related health technologies. The general approval process requires applicants to submit a formal registration dossier for evaluation, after which ARMED may request additional information, conduct site inspections, or refer products to its scientific advisory committees before issuing a marketing authorization. Timelines are officially targeted at 12 to 24 months but can extend further due to capacity constraints and administrative backlogs.

Submission requirements mandate the appointment of a locally registered legal representative or in-country agent who assumes regulatory and commercial responsibility for the product. Dossiers are generally expected to follow the Common Technical Document (CTD) format, and ARMED increasingly references guidance from the African Union's African Medicines Agency (AMA) framework and the Southern African Development Community (SADC) harmonization guidelines. Products registered by stringent regulatory authorities (SRAs) such as the EMA, US FDA, or WHO-prequalified products may benefit from abbreviated or expedited review pathways, particularly for essential medicines and priority health technologies. Recent reforms under Mozambique's health sector strategic plans have focused on strengthening ARMED's institutional capacity, introducing electronic submission systems, and aligning national standards with SADC and Africa CDC regulatory harmonization initiatives to reduce duplication and improve efficiency.

Public procurement of health products in Mozambique is centrally coordinated through MISAU and its Central Medical Store, the Central de Medicamentos e Artigos Médicos (CMAM), which manages the quantification, procurement, storage, and distribution of medicines, medical devices, diagnostics, and health commodities across the national health system. Procurement follows the national public procurement legal framework governed by Decree No. 5/2016, which outlines competitive tendering procedures, direct contracting thresholds, and framework agreements. CMAM operates provincial warehouses and coordinates last-mile distribution through district health directorates, though supply chain gaps remain a persistent challenge particularly in remote areas. The Unidade Funcional de Gestão das Aquisições (UGEA) within MISAU oversees compliance with procurement regulations and tender processes for health sector acquisitions.

Mozambique's public health system is heavily dependent on donor financing, which accounts for a substantial share of health commodity procurement. Key multilateral and bilateral partners active in the country include the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID through its global health supply chain programs (including GHSC-PSM), UNICEF, the World Health Organization (WHO), and Gavi, the Vaccine Alliance, which supports immunization commodity procurement and cold chain strengthening. These donors often procure health products through their own international tendering mechanisms or UN agency channels (such as UNICEF Supply Division or UNDP), bypassing or complementing the national CMAM system. Local manufacturing capacity in Mozambique remains limited, and there are currently no strong enforceable local manufacturing preference policies in procurement; however, regional integration frameworks under SADC and the African Continental Free Trade Area (AfCFTA) are gradually creating incentives for regional sourcing and local production development over the longer term.