The Tanzania Medicines and Medical Devices Authority (TMDA) is the government regulator that makes sure medicines, vaccines, medical devices and diagnostics sold in mainland Tanzania are safe, effective and of good quality. This guide explains what TMDA does, how it came to replace part of the former Tanzania Food and Drugs Authority (TFDA), and how patients, pharmacies and businesses deal with it.
From TFDA to TMDA
Until 2019, food, medicines, cosmetics and medical devices were all regulated by the Tanzania Food and Drugs Authority. Amendments made through the Finance Act, 2019 moved the regulation of food and cosmetics to the Tanzania Bureau of Standards (TBS) and renamed the remaining body the Tanzania Medicines and Medical Devices Authority, which began working under its new name on 1 July 2019. The governing law is now the Tanzania Medicines and Medical Devices Act (Cap. 219). Our article on the Tanzania Food and Drugs Authority explains the change in more detail.
What TMDA Regulates
- human and veterinary medicines, including vaccines and herbal medicines with medicinal claims;
- medical devices and in-vitro diagnostics, such as test kits and laboratory reagents;
- clinical trials of medicines and devices;
- premises that manufacture, import, store or sell these products, such as pharmacies and wholesalers (together with the Pharmacy Council for professional licensing).
Food, food supplements without medicinal claims and cosmetics are no longer regulated by TMDA; they fall under the Tanzania Bureau of Standards.
Main Functions of the Tanzania Medicines and Medical Devices Authority
- Product registration: assessing evidence of quality, safety and effectiveness before a product can be sold.
- Import and export permits: controlling what enters and leaves the country.
- Inspection and enforcement: inspecting facilities, seizing substandard or falsified products and taking legal action.
- Laboratory testing: testing samples to confirm quality.
- Pharmacovigilance: collecting reports of side effects and acting on safety problems, including product recalls.
- Public education: warning about unregistered and fake products.
Zanzibar has its own regulator for food, drugs and cosmetics, so these functions apply to mainland Tanzania.
How Patients Can Use TMDA
- Buy medicines only from licensed pharmacies and accredited drug dispensing outlets (ADDOs).
- Check that the product is registered; TMDA publishes registers of approved products on its website.
- Report suspected side effects or poor-quality medicines to TMDA, through a health worker or directly.
- Follow TMDA public notices about recalled or banned products.
For Businesses
Companies that want to import, manufacture or distribute medicines or medical devices must register products and premises with TMDA, obtain import permits and follow good manufacturing and distribution practices. Read about the industry in our guide to pharmaceutical companies in Tanzania and our profile of Shelys Pharmaceuticals.
TMDA in the Wider Health System
Safe medicines are one part of a functioning health system that also depends on primary care, financing and trained staff; see our overviews of primary health care in Tanzania and the health care system in Tanzania. Official information, product registers and public notices are available on the TMDA website, and the World Health Organization’s regulation and prequalification work explains how national regulators like TMDA fit into global medicine safety efforts.
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