TMDA Profile

About TMDA

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 and diagnostics. 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.

Vision

To be the leading Regulatory Authority in ensuring safe, quality and effective, medicines, medical devices, diagnostics and other health related products for all.

Mission

To protect and promote public health by ensuring quality, safety and effectiveness of medicines, medical devices, diagnostics and other health related products.

Philosophy

TMDA strives to offer quality regulatory services in the pursuit of protecting public health and environment by using competent and dedicated staff.

Core Values

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:

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 Strive to deliver the best services to customers with utmost professionalism
Teamwork Support one another, work cooperatively and respect one another’s views
Accountability Being accountable for actions and outcomes
Transparency Operate in a fully transparent manner and communicate openly and timely to the relevant stakeholders

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 and diagnostics 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:-

  1. Regulating the manufacturing, importation, distribution and selling of medicines, medical devices and diagnostics;
  2. Prescribing standards of quality, safety and effectiveness for medicines, medical devices and diagnostics;
  3. Inspecting manufacturing industries and business premises dealing with regulated products and make sure the standards required are attained;
  4. Evaluating and registering medicines, medical devices and diagnostics so as to reach the required standards before marketing authorization;
  5. Issuance of business permits for premises dealing with regulated products;
  6. Assessing the quality, safety and efficacy of controlled drugs;
  7. Conducting laboratory investigations for regulated products to ascertain their quality specifications;
  8. Conducting pharmacovigilance of medical products and vigilance of medical devices and diagnostics circulating on the market;
  9. Promoting rational use of medicines, medical devices and diagnostics; and
  10. Educating and sharing accurate and reliable information to stakeholders and the general public on regulatory matters.
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