Tanzania

The Tanzania Medicines and Medical Devices Authority (TMDA) serves as the primary national regulatory body responsible for overseeing the registration, quality assurance, and post-market surveillance of medicines, medical devices, diagnostics, and related health products in Tanzania. The TMDA operates under the Tanzania Medicines and Medical Devices Act No. 3 of 2019, which consolidated and replaced earlier legislation and significantly expanded the authority's mandate to include digital health tools and in vitro diagnostics. All health products intended for the Tanzanian market must undergo a formal registration process, which involves submission of a product dossier, evaluation by TMDA technical committees, and issuance of a marketing authorization before any commercialization or importation is permitted.

Applicants are required to appoint a local authorized representative or registered agent based in Tanzania to liaise with TMDA throughout the registration and post-market phases. Dossier submissions are generally aligned with the Common Technical Document (CTD) format, and TMDA recognizes accelerated review pathways for products pre-approved by stringent regulatory authorities (SRAs) such as the US FDA, EMA, or WHO-prequalified products, which can reduce review timelines. Tanzania is an active member of the African Medicines Regulatory Harmonization (AMRH) initiative and participates in the East African Community (EAC) mutual recognition framework, allowing applicants to leverage regional harmonization procedures where applicable. Recent reforms introduced electronic submission portals and risk-based classification systems for medical devices and diagnostics, streamlining the pathway for lower-risk product categories.

Public procurement of health products in Tanzania is centrally coordinated through the Medical Stores Department (MSD), a government agency operating under the Ministry of Health, which serves as the primary procurement and distribution entity for medicines, medical devices, diagnostics, and health commodities across public health facilities nationwide. The MSD conducts competitive tendering processes in accordance with the Public Procurement Act and its regulations, overseen by the Public Procurement Regulatory Authority (PPRA). Procurement decisions are informed by the national Essential Medicines List and are subject to budget allocations from both central government funds and pooled health sector financing mechanisms. Regional and district health authorities may supplement central procurement through decentralized budget lines, though the MSD remains the dominant channel for public sector supply.

Donor-funded procurement represents a substantial share of Tanzania's health product market, with major international partners including the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID through its implementing mechanisms such as PEPFAR and PMI, UNICEF Supply Division, and Gavi the Vaccine Alliance collectively financing a significant proportion of commodities, particularly for HIV, malaria, maternal and child health, and immunization programs. These channels often procure through international competitive bidding and may bypass standard TMDA registration requirements for WHO-prequalified or SRA-approved products under emergency or donor framework agreements. The private sector, comprising retail pharmacies, private hospitals, and faith-based health facilities, sources products through licensed importers and distributors subject to TMDA oversight. Tanzania has articulated ambitions to promote local pharmaceutical manufacturing under its national industrial policy and the African Union's Pharmaceutical Manufacturing Plan for Africa (PMPA), with preferential procurement policies under development to incentivize locally manufactured health products and reduce import dependency.