Uganda

The National Drug Authority (NDA), established under the National Drug Policy and Authority Act (Cap. 206) and its subsequent amendments, serves as Uganda's primary regulatory body for all health products, including pharmaceuticals, medical devices, diagnostics, and increasingly, digital health technologies. The NDA operates under the Ministry of Health and is mandated to ensure that all health products marketed in Uganda meet defined standards of quality, safety, and efficacy. The general approval process requires manufacturers or their local representatives to submit a registration application, after which the NDA conducts a dossier review, which may include product testing, facility inspection, and expert committee evaluation before granting a Certificate of Product Registration.

Applications to the NDA must be submitted in the Common Technical Document (CTD) format, and the authority also accepts dossiers reviewed and approved by stringent regulatory authorities (SRAs) such as the US FDA, EMA, or WHO Prequalification Programme, which may be eligible for an abridged or expedited review pathway. Applicants are required to appoint a locally registered entity as the authorized agent or local technical representative responsible for post-market obligations. Uganda is an active member of the East African Community (EAC) and participates in the EAC Medicines Regulatory Harmonization (MRH) initiative, which aims to streamline joint reviews and mutual recognition of approvals across member states. The NDA has undertaken ongoing reforms to digitize application submissions through its electronic regulatory management system and to align its guidelines with international best practices, reducing duplication and improving review efficiency.

Public sector procurement of health products in Uganda is primarily coordinated through the Ministry of Health (MOH), with the National Medical Stores (NMS) serving as the central procurement and distribution agency for essential medicines, medical supplies, and health commodities for government health facilities. The Public Procurement and Disposal of Public Assets Authority (PPDA) governs the overall public procurement framework, establishing rules for open tenders, restricted bidding, and direct procurement. Health product tenders are typically advertised publicly, and suppliers must meet registration and quality assurance criteria set by the NDA. The Uganda Health Marketing Group (UHMG) and the Joint Medical Store (JMS), a private not-for-profit entity, also play important roles in supplementing public supply chains, particularly for faith-based and private health facilities.

Uganda relies significantly on donor-funded procurement channels for a substantial portion of its health commodity needs. Major international partners, including UNICEF Supply Division, the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID through its implementing mechanisms such as GHSC-PSM, and Gavi, the Vaccine Alliance, finance and procure large volumes of vaccines, diagnostics, antiretrovirals, and other essential health products. These donor-funded procurements often follow international competitive tendering processes and require WHO Prequalification or SRA approval as a baseline quality standard. Uganda's government has expressed policy interest in promoting local manufacturing capacity, including through participation in the African Union's Partnerships for African Vaccine Manufacturing (PAVM) framework and offering incentives under the Uganda Investment Authority for domestic health product manufacturers, though local manufacturing preferences in formal tender evaluation criteria remain at an early stage of formalization.