Mozambique

In Mozambique, the regulation of health products including pharmaceuticals, medical devices, diagnostics, and increasingly digital health solutions falls primarily under the Ministry of Health (Ministério da Saúde, MISAU), with technical oversight provided by the National Medicine Quality Control Laboratory (LNCQM) and the Directorate of Pharmacy (Direcção de Farmácia, DIFARE). The principal legislative framework is anchored in the National Medicines Policy and supplementary regulatory decrees governing the registration, importation, distribution, and post-market surveillance of health products. All health products intended for the Mozambican market must undergo a formal registration process, which includes technical evaluation of quality, safety, and efficacy documentation before a marketing authorisation is granted.

Applicants are generally required to appoint a local representative or registered entity in Mozambique to act as the regulatory liaison throughout the submission and post-registration phases. Dossier submissions are broadly aligned with internationally recognised standards, and CTD (Common Technical Document) format is increasingly accepted, reflecting Mozambique's alignment with SADC (Southern African Development Community) harmonisation initiatives and collaboration with the African Medicines Regulatory Harmonisation (AMRH) programme. Products registered by stringent regulatory authorities such as the EMA, US FDA, or WHO-prequalified products may benefit from an expedited or simplified review pathway. Recent reforms have focused on strengthening pharmacovigilance systems, improving transparency in the registration process, and progressively harmonising standards with regional bodies including SADC and the African Union's Africa Medicines Agency (AMA) framework.

Public procurement of health products in Mozambique is primarily coordinated through MISAU, with the Central de Medicamentos e Artigos Médicos (CMAM) serving as the central procurement and supply chain management agency responsible for sourcing, warehousing, and distributing medicines, medical devices, and diagnostics to public health facilities nationwide. Procurement processes are governed by the national public procurement law (Lei de Contratação Pública) and are generally conducted through competitive tendering procedures. CMAM operates a centralised procurement model, though provincial health directorates (Direcções Provinciais de Saúde) play a role in last-mile distribution and some decentralised purchasing for local facility needs.

Mozambique is heavily reliant on donor-funded procurement channels, which represent a significant proportion of total health product supply. Key partners include the Global Fund to Fight AIDS, Tuberculosis and Malaria, PEPFAR and USAID through mechanisms such as GHSC-PSM, UNICEF for essential medicines and diagnostics, and Gavi for vaccines and related supplies. These donors often procure directly through international competitive tendering or prequalified supplier frameworks, bypassing some elements of the national registration process for emergency or programmatic needs. Local manufacturing capacity remains limited, and there is no strong formal local manufacturing preference policy in practice, though national health strategies reference ambitions to develop domestic production capacity in line with broader African Union goals for pharmaceutical self-sufficiency.