Tanzania

The Tanzania Medicines and Medical Devices Authority (TMDA) serves as 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 was established under the Tanzania Medicines and Medical Devices Act No. 3 of 2019, which replaced the earlier Tanzania Food and Drugs Authority (TFDA) framework and significantly expanded the regulatory mandate to better address the growing complexity of the health products landscape. The general approval process requires manufacturers or their authorized local representatives to submit a formal registration application to TMDA, which then conducts a dossier review, product evaluation, and where necessary, facility inspection before granting market authorization.

All applicants are required to appoint a locally registered representative or agent based in Tanzania who acts as the primary liaison with TMDA throughout the registration and post-market surveillance lifecycle. Dossier submissions are generally expected to follow the Common Technical Document (CTD) format, and TMDA recognizes and accepts applications evaluated through reference stringent regulatory authorities (SRAs) such as the US FDA, EMA, and Health Canada, as well as approvals granted through the African Medicines Regulatory Harmonization (AMRH) initiative and the African Union Development Agency (AUDA-NEPAD) collaborative registration procedures. Tanzania is also an active participant in the East African Community (EAC) mutual recognition framework, which allows products approved in one EAC member state to be fast-tracked in others. Recent reforms under TMDA have introduced risk-based classification for medical devices, strengthened post-market surveillance requirements, and expanded digital submission capabilities through the TMDA e-portal to reduce administrative delays and improve transparency.

Public procurement of health products in Tanzania is primarily coordinated through the Medical Stores Department (MSD), a government agency under the Ministry of Health that serves as the central warehousing and distribution body for medicines, diagnostics, medical devices, and health commodities for public health facilities across the country. MSD procures products through national competitive tenders governed by the Public Procurement Act and overseen by the Public Procurement Regulatory Authority (PPRA). The Ministry of Health sets national health commodity policies and priorities, while regional and district health authorities manage facility-level requisitions through MSD's pull-based ordering system. Zanzibar maintains a semi-autonomous procurement structure under its own Ministry of Health, with some shared frameworks aligned to the mainland but distinct operational management through the Zanzibar Medical Stores.

Donor-funded and vertical program procurement represents a substantial share of Tanzania's total health commodity supply, with major contributions from the Global Fund to Fight AIDS, Tuberculosis and Malaria, the US Government through USAID and PEPFAR, Gavi the Vaccine Alliance, and UNICEF Supply Division. These channels often procure through international competitive bidding using prequalified suppliers listed by the WHO Prequalification Programme or approved SRAs, frequently bypassing local TMDA registration requirements under specific government-to-government or humanitarian exemptions. Tanzania has introduced policies encouraging local manufacturing and preferential procurement for domestically produced health products, aligned with broader African Union and EAC strategies to strengthen regional pharmaceutical manufacturing capacity. The country's Business Environment Reforms and the Tanzania Development Vision 2025 further emphasize import substitution and incentives for local production, making local manufacturing partnerships an increasingly important consideration for market entry strategies.