Tanzania Medicines and Medical Devices Authority (TMDA) is an Executive Agency under the Ministry of Health, Community Development, Gender, Elderly and Children (MOHCDGE ). TMDA is responsible for regulating safety, quality and effectiveness of medicines, medical devices and diagnostics. TMDA main responsibility is stated in the Health policy, 2007 and its mandate is stipulated in the Tanzania food, drugs and cosmetics act (TFDCA) cap. 219 as ammended by the Finance Act of 2019. The act provides for the efficient and comprehensive Regulation and control of safety and quality of medicines, medical devices and diagnostics in Tanzania mainland. In order to improve public service delivery, TMDA is managed as an Executive Agency in accordance with the Executive Agencies Act, cap. 245 as amended in 2009. Specific functions of TMDA as prescribed in section 5 of the TFDCA include the following:-
1.Regulate all matters relating to quality and safety of human and veterinary medicines, herbal medicines, medical devices and diagnostics,
2.Regulate in accordance with the TFDCA, the importation, manufacture, labeling, marking or identification, storage, promotion, sell and distribution of medicines, herbal medicines medical devices and diagnostics or any materials or substances used in the manufacture of products regulated under TFDCA,
3.Ensure that evidence of existing and new Adverse Events, interactions and information about Pharmacovigilance of products being monitored globally, are analyzed and acted upon,
4.Ensure that, clinical trials on medicines, medical devices and herbal medicines are being conducted in accordance with prescribed standards,
5.Foster co-operation between the TMDA and other institutions or organizations and other stakeholders,
6.Promote rational use of medicines, medical devices and herbal medicines establish and maintain the Tanzania National Formulary and Tanzania Pharmacopoeia,
7.Approve and register products regulated under the TFDCA, manufactured within or imported into, and intended for use in the United Republic of Tanzania,
8.Examine, grant, issue, suspend, cancel and revoke certificates and licenses or permits issued under the TFDCA,
9.Appoint inspectors and order inspection of any premises,
10. Provide the public with unbiased information on products regulated under the TFDCA,
11. Prescribe standards of quality in respect of products regulated under this Act, manufactured or intended to be manufactured or imported into or exported from the United Republic of Tanzania,
12. Maintain registers prescribed under the TFDCA be responsible for its human resource management and development,
13. Attend to and, where possible, take legal measures on complaints made by consumers against manufacturers of products regulated under this Act,
14. Carry out such other functions as may be conferred upon the authority by any written law or as are incidental to the performance of its functions under the TFDCA,
To be the leading Regulatory Authority in ensuring safety, quality and effectiveness of medicines, medical devices and diagnostics in Africa.
To protect and promote public health by ensuring safety, quality and effectiveness of medicines, medical devices and diagnostics.
TFDA shall always embrace and institutionalize values that ensure satisfaction and expectations of stakeholders. All TMDA employees are expected to be committed to upholding the following values as character of identity;
QUALITY POLICY STATEMENT
TMDA is committed to provide quality services in response to customer needs and expectations. We 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.
We commit ourselves to comply with requirements of the ISO 9001:2015 standard and continually improve effectiveness of Quality Management System. We shall manage and provide resources for continuous improvement of our services to ensure customer satisfaction.
TFDA strives to offer quality regulatory services in the pursuit of protecting public health and environment by using competent and dedicated staff.
To achieve TFDA’s vision and mission, seven (7) objectives and respective rationale have been developed.
For each objective, several strategies, targets and performance indicators have been identified. The objectives are;
1.HIV and AIDS infections and Non Communicable Diseases (NCDs) reduced and services improved,
2.National Anti-Corruption strategy effectively implemented and sustained,
3.Gender and environmental issues improved,
4.Quality, safety and effectiveness of medicines, cosmetics, medical devices and diagnostics assured,
5.Laboratory Services improved,
6.Public education strengthened and Customer Services improved; and
7.Institutional capacity to deliver regulatory services strengthened.