Tanzania

The Tanzania Medicines and Medical Devices Authority (TMDA) serves as the primary regulatory authority overseeing the registration, quality control, and post-market surveillance of pharmaceuticals, medical devices, diagnostics, and digital health products in Tanzania. Established under the Tanzania Medicines and Medical Devices Act No. 7 of 2019, which replaced the previous Tanzania Food and Drugs Authority (TFDA), TMDA operates under the Ministry of Health. All health products must be registered with TMDA before they can be legally imported, distributed, or sold in the country. The general approval process involves submission of a product dossier, laboratory testing, facility inspections where applicable, and evaluation by TMDA technical committees, culminating in a registration certificate valid for five years and subject to renewal.

Applicants are required to appoint a local registered representative or agent based in Tanzania who liaises with TMDA throughout the registration process. Dossier submissions are expected to follow the Common Technical Document (CTD) format, and TMDA also recognizes the ASEAN Common Technical Document (ACTD) format for certain product categories. Tanzania is a member of the East African Community (EAC) and participates in regional harmonization efforts under the EAC Medicines Regulatory Harmonization (MRH) Programme, which can accelerate review timelines for products already approved in partner states. TMDA has also introduced an expedited review pathway for essential medicines and products addressing public health priorities, and has progressively adopted the African Medicines Agency (AMA) framework as it develops, signaling ongoing alignment with continental regulatory reforms.

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 that serves as the primary supply chain and distribution entity for public health facilities across the country. National procurement decisions are guided by the Government Procurement Services Agency (GPSA), formerly known as the Central Tender Board, and are governed by the Public Procurement Act and its accompanying regulations. The Ministry of Health develops the national essential medicines list and sets quantification priorities, while MSD manages tendering, warehousing, and last-mile distribution to regional and district health facilities. Procurement processes are competitive and typically require full TMDA registration as a prerequisite for supplier eligibility, alongside compliance with good storage and distribution practices.

The private sector plays a significant complementary role in health product distribution, served by a network of licensed wholesalers, distributors, and retail pharmacies that procure independently from registered suppliers and manufacturers. Tanzania is heavily supported by international donor and financing channels, including the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID through supply chain programs such as GHSC-PSM, UNICEF, and Gavi, the Vaccine Alliance, which collectively fund and supply a substantial proportion of essential medicines, vaccines, diagnostics, and health commodities. These programs often operate parallel procurement channels but increasingly align with government systems to strengthen sustainability. Tanzania has articulated commitments to local manufacturing promotion through policies supporting the pharmaceutical industry, including preferential margins for locally manufactured products in public tenders, consistent with the broader EAC and African Union strategies to expand domestic production capacity on the continent.