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.

LIST OF TMDA REGULATIONS

S/N NAME SUBJECT REMARKS
1. The Tanzania Food, Drugs and Cosmetics (Orphan Medicines) Regulations GN. 412 OF 2018 Orphan Drugs Currently enforced
2. The Tanzania Food, Drugs and Cosmetics (Registration of Medicinal Products) Regulations GN. 314, 2015 Registration of Medicinal Product Currently enforced
3. The Tanzania Food, Drugs and Cosmetics (Good Manufacturing Practice Enforcement) Regulations, GN. 295, 2018 Good Manufacturing Practice Enforcement Currently enforced
4. The Tanzania Food, Drugs and Cosmetics (Registration of Premises, Importation and Exportation of Pharmaceutical Products and Raw Materials) GN. 312 Regulation 2010 Registration of Premises, Importation and Exportation of Pharmaceutical Products and Raw Materials Currently enforced
5. The Tanzania Food, Drugs and Cosmetics (Control of Drug and herbal Drugs Promotion) GN. 159 Regulations 2010 Control of Drug and herbal Drugs Promotion Currently enforced
6. The Tanzania Food, Drugs and Cosmetics (Pharmacovigilance) GN. 296 Regulations, 2018 Pharmacovigilance Currently enforced
7. The Tanzania Medicines and Medical Devices (Fees and Charges) Regulations GN. 686 , 2021. Fees and Charges Currently enforced
8. The Tanzania Food, Drugs and Cosmetics (Scheduling of Medicine) GN. 63 Regulations, 2015 Scheduling of Medicine Currently enforced
9. The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) GN. 53 Regulations, 2013 Clinical Trial Control Currently enforced
10. The Tanzania Food, Drugs and Cosmetics(Control of Medical Devices) Regulations, GN. 315, 2015 Currently enforced
11. The Tanzania Food, Drugs and Cosmetics (The Recall, Handling and Disposal of Unfit Medicines and Cosmetics) GN. 313 Regulations, 2015 The Recall, Handling and Disposal of Unfit Medicines Currently enforced
12. The Tanzania Medicines and Medical Devices (Appointment of Inspectors) Order, 2020 GN NO. 257, 2020 Appointment of Inspectors Currently enforced
13. The Tanzania Medicines and Medical Devices (Appointment of Inspectors) Order, 2020 GN. No. 191, 2020 Appointment of Inspectors Currently enforced
14. The Tanzania Food, Drugs and Cosmetics (appointment of Inspectors) Order, 2016 GN No. 275, 2016 Appointment of Inspectors Currently enforced
15. The Tanzania Food, Drugs and Cosmetics(appointment of Analysts) Order, 2016 GN. 270, 2016 Appointment of Analysts Currently enforced
16. The Tanzania Medicines and Medical Devices (appointment of Inspectors) Order, 2020 GN No. 1009, 2020 Appointment of Inspectors Currently enforced
17. The Tanzania Food, Drugs and Cosmetics (appointment of Inspectors and analysts) Order, 2011 GN No. 209, 2011 Appointment of Inspectors Currently enforced
18. The Tanzania Medicines and Medical Devices (appointment of Inspectors) Order, 2021 GN No. 190, 2021 Appointment of Inspectors Currently enforced