Frequently Asked Questions
Tanzania Medicines and Medical Devices Authority (TMDA) is a semi-autonomous regulatory body under the Ministry of Health (MoH); which is responsible for protecting and promoting public health by ensuring safety, quality and effectiveness of medicines, medical devices and diagnostics. It was established under the Tanzania Medicines and Medical Devices Act, Cap 219.
TMDA, formerly known as TFDA became operational on 1st July, 2003. However, the name TFDA was statutorily changed into TMDA on 1st July, 2019 after the amendment of the Tanzania Food, Drugs and Cosmetics Act, Cap 219 by the Finance Act No. 8 of 2019. This resulted into parting in the regulation of medicinal products from that of food products. In view of this, TMDA is currently mandated to regulate three (3) types of products namely: medicines, medical devices and diagnostics whereas TFDA by then, was mandated to regulate five (5) types of products namely: food, medicines, cosmetics, medical devices and diagnostics.
TMDA became operational with effect from 1st July, 2019 following the amendment of the Tanzania Food, Drugs and Cosmetics Act, Cap 219; whereby the regulation of two (2) types of products i.e. food and cosmetics were shifted from the then Tanzania Food and Drugs Authority (TFDA) to Tanzania Bureau of Standards (TBS).
TMDA is a regulatory body under the Ministry of Health (MoH) responsible for protecting and promoting public health by ensuring quality, safety and effectiveness of medicines, medical devices and diagnostics. It was established under the Tanzania Medicines and Medical Devices Act, Cap 219.
On the other hand, TBS is a parastatal organization under the Ministry of Investment, Industry and Trade
TMDA regulates human and veterinary medicines (which include herbal and biocidal products), medical devices and diagnostics.
No, TMDA does not regulate traditional medicines. Such medicines are regulated by Traditional and Alternative Heath Practice Council click here for more details.
To register masks, PPEs and hand sanitizers, you are required to fill an application form and submit the documents to TMDA along with the product samples click here for more details.
As of April, 2020 a total of thirteen (13) domestic pharmaceutical industries that manufactures different dosage formulations have been approved by TMDA. Moreover, there are numerous foreign manufacturers which have been approved to supply pharmaceutical products in Tanzania.
As of April, 2020 a total of eighty one (81) manufacturers have been approved by TMDA out of which, six (6) are domestic and seventy five (75) of them are foreign.
Yes, there are several guidelines which are approved under the EAC – MRH programme and have been adapted by individual NMRAs including Tanzania. For accessing these documents please clicks here for more details.