Tanzania

The Tanzania Medicines and Medical Devices Authority (TMDA) is the primary national regulatory authority responsible for overseeing the safety, quality, and efficacy of medicines, medical devices, diagnostics, and related health products in Tanzania. TMDA operates under the Tanzania Medicines and Medical Devices Act No. 7 of 2019, which replaced the earlier Tanzania Food and Drugs Authority (TFDA) framework and significantly expanded the regulatory mandate to explicitly cover medical devices and in vitro diagnostics. The general approval process requires manufacturers or their local authorized representatives to submit a product dossier for evaluation, following which TMDA conducts a technical review encompassing safety, quality, and efficacy data before issuing a product registration certificate. Registration certificates are typically valid for five years and must be renewed prior to expiry.

Key submission requirements include the appointment of a locally registered authorized representative or agent, who serves as the primary point of contact with TMDA for all regulatory correspondence. Tanzania accepts dossiers prepared in accordance with the Common Technical Document (CTD) format and the ASEAN Common Technical Dossier (ACTD) format, and also recognizes submissions aligned with the East African Community (EAC) harmonized guidelines. TMDA participates in the African Medicines Regulatory Harmonization (AMRH) initiative and has adopted reliance pathways that allow expedited review for products already approved by stringent regulatory authorities (SRAs) such as the US FDA, EMA, or WHO-prequalified products. Notable recent reforms include the introduction of a risk-based classification system for medical devices and diagnostics, a dedicated digital health product regulatory pathway under development, and an online e-submission portal to streamline application lodgment and tracking.

Public sector procurement of health products in Tanzania is centralized primarily through the Medical Stores Department (MSD), a government agency operating under the Ministry of Health that serves as the principal warehousing and distribution entity for public health facilities across mainland Tanzania. The Public Procurement Act and its associated regulations, overseen by the Public Procurement Regulatory Authority (PPRA), govern tendering and contracting processes for health commodities. Procurements above defined thresholds are subject to competitive tendering, and the Government of Tanzania uses framework agreements and long-term contracts to ensure continuity of supply. Zanzibar maintains a semi-autonomous procurement structure through its own Ministry of Health and the Zanzibar Medical Stores, though coordination with mainland MSD mechanisms occurs for certain programs. The Tanzania Procurement Services Agency (GPSA) also plays a role in aggregating procurement across government entities to achieve economies of scale.

The private sector in Tanzania is a significant channel for health product distribution, served by a network of licensed importers, wholesalers, and retail pharmacies regulated by TMDA. Mission and faith-based health facilities, which constitute a substantial portion of the non-government health infrastructure, often procure through the Joint Medical Stores (JMS) or direct supplier arrangements. Donor-funded procurement channels are critically important in Tanzania, with major contributors including PEPFAR via USAID, the Global Fund to Fight AIDS, Tuberculosis and Malaria, Gavi the Vaccine Alliance, UNICEF Supply Division, and the World Bank. These donors frequently procure through international mechanisms such as the UNICEF Supply Division catalogue or WHO prequalification lists, which necessitates that suppliers hold relevant international certifications in addition to TMDA registration. Tanzania does not currently impose formal mandatory local manufacturing preference policies, but the government has expressed strategic ambitions to develop domestic pharmaceutical manufacturing capacity in alignment with the Africa Union's Pharmaceutical Manufacturing Plan for Africa, and preference for locally manufactured products is an emerging policy discussion within national health sector strategies.