Acts and Regulations
ACTS
TMDA is an organization which operates as a Regulatory Authority and an Executive Agency. It was established as the Regulatory Authority under Section 4 (1) of the Tanzania Medicines and Medical Devices Act, Cap 219 and as the Executive Agency under Section 3 (1) of the Executive Agencies Act, Cap 245.
Historically, laws for regulating medicines and food products in Tanzania began in 1978 when the Pharmaceuticals and Poisons Act of 1978 and the Food (Control of Quality) Act of 1978 were enacted by the Parliament. The Pharmaceuticals and Poisons Act established the Pharmacy Board which was mandated to regulate medicines and the Food (Control of Quality) Act established the Food Control Commission which regulated food products. In 2003, the two legislations were merged to form Tanzania Food, Drugs and Cosmetics Act of 2003 which established Tanzania Food and Drugs Authority (TFDA). TFDA was mandated to regulate, medicines, food, cosmetics and medical devices.
In 2019, the Tanzania Food, Drugs and Cosmetics Act was again amended and renamed to Tanzania Medicines and Medical Devices Act which also established TMDA to regulate medicines, medical devices and diagnostics only. The amendments were made to streamline processes, reducing duplication of efforts and minimizing the number of permits issued by different regulators in Tanzania to bolster the business environment including promoting manufacturing.
The renaming and shifting of responsibilities were made through the Finance Act, No. 8 of 2019 which also amended the Standards Act, Cap 130 to allow for the Tanzania Bureau of Standards (TBS) to regulate food and cosmetics. TBS has now assumed all regulatory functions for regulating food and cosmetics to include registration of food and cosmetic products, licensing of premises, import and export control, inspection of premises, disposal of unfit products, recall from the market, post marketing surveillance, food borne diseases surveillance and control of advertisements.