Tanzania Medicines and Medical Devices Authority (TMDA) is an Executive Agency under the Ministry of Health, Community Development, Gender, Elderly and Children (MOHCDGE). TMDA which was formerly known as Tanzania Food and Drugs Authority (TFDA) was established in 2003 after enactment by the Parliament of the Tanzania Food, Drugs and Cosmetics Act, Cap 219. This Act was later amended in 2019 to Tanzania Medicines and Medical Devices Act, Cap 219 after the shift of responsibilities of regulating food and cosmetics to Tanzania Bureau of Standards (TBS). The change in legislative framework which was done through the Finance Act, No. 8 of 2019 also resulted into the change of name to TMDA.
TMDA is now responsible for regulating quality, safety and effectiveness of medicines, medical devices, diagnostics, biocidals and tobacco products. In order to improve public service delivery, TMDA is managed as an Executive Agency in accordance with the Executive Agencies Act, Cap. 245 which was also amended in 2009.
To be the leading Regulatory Authority in ensuring safe, quality and effective, medicines, medical devices, diagnostics and other health related products for all.
To protect and promote public health by ensuring quality, safety and effectiveness of medicines, medical devices, diagnostics and other health related products.
TMDA strives to offer quality regulatory services in the pursuit of protecting public health and environment by using competent and dedicated staff.
TMDA always embraces and institutionalizes values that guarantee customer satisfaction. All TMDA employees are expected to be committed to upholding the following values to define their character and personal attributes:
|Transparency||Operate in a fully transparent manner and communicate openly and timely to the relevant stakeholders|
|Accountability||Being accountable for actions and outcomes|
|Quality||Strive to deliver the best services to customers with utmost professionalism|
|Teamwork||Support one another, work cooperatively and respect one another’s views|
|Integrity||To uphold highest standards of conduct and commitment while acting in the best interest of the country|
|Customer focus||Always treat customers and colleagues with courtesy and be responsive timely and proactive to meet their needs|
Quality Policy Statement
TMDA is committed to provide quality services in response to customer needs and expectations. TMDA shall strive to balance the interests of our stakeholders without compromising quality, safety and effectiveness of medicines, medical devices, diagnostics, biocidals and tobacco products by managing the Authority with utmost professionalism.
TMDA is committed to comply with the requirements of ISO 9001:2015 Standard and continually improve the effectiveness of the Quality Management System. It shall manage and provide resources for continuous improvement of services to ensure customer satisfaction.
Roles and Functions of TMDA
Pursuant to the Tanzania Medicines and Medical Devices Act, Cap 219, TMDA discharges the following functions:-
- Regulating the manufacturing, importation, distribution and selling of medicines, medical devices, diagnostics, biocidals and tobacco products;
- Prescribing standards of quality, safety and effectiveness for medicines, medical devices, diagnostics, biocidals and tobacco products;
- Inspecting manufacturing industries and business premises dealing with regulated products and make sure the standards required are attained;
- Evaluating and registering medicines, medical devices, diagnostics, biocidals and tobacco products so as to reach the required standards before marketing authorization;
- Issuance of business permits for premises dealing with regulated products;
- Assessing the quality, safety and efficacy of controlled drugs;
- Conducting laboratory analysis for regulated products to ascertain their quality specifications;
- Conducting pharmacovigilance of medical products and vigilance of medical devices, diagnostics, biocidals and tobacco products circulating on the market;
- Promoting rational use of medicines, medical devices, diagnostics, biocidals and tobacco products; and
- Educating and sharing accurate and reliable information to stakeholders and the general public on regulatory matters.
- To ensure that Tobacco products circulating in the market are appropriate for the protection of public health