Below are the main regulatory government agencies responsible for regulating both private and government suppliers and quality of health commodities. Tanzania Medicines and Medical Devices Authority (TMDA) and Tanzania Bureau of Standards (TBS) have laboratories to conduct quality control. A list of companies is provided in the 4.3 Tanzania Laboratory and Quality Testing Companies Contact List.

• Tanzania Medicines and Medical Devices Authority (TMDA)
• Government Chemist Laboratory Agency (GCLA)
• National Health Quality Laboratory Assurance Training Centre (NHLQATC)

Tanzania Medicines and Medical Devices Authority (TMDA)

TMDA is a governmental executive agency under Ministry of Health Community Development Gender Elderly and Children (MOHCDGEC) with the mandate to ensure the quality, the safety and the effectiveness of medicines and medical devices in order to protect and promote public health. It conducts laboratory analysis and testing to confirm and validate information provided on the health commodities and produce recommendations based on the outcomes. The major functions of TMDA as stipulated in the amended TFDA act 2003 include:

1. Regulating the manufacture, 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.

TMDA complies with the requirements of the ISO/IEC 17025:2017 and WHO Good Practices for Pharmaceutical Quality Control Laboratories to ensure that laboratory services rendered are of quality and efficient. TMDA has two main laboratories whereby one is based in the Sub-office in Dar es Salaam and the other in Mwanza at the Lake Zone.

Government Chemist Laboratory Agency (GCLA)

GCLA is a government agency with a mission to provide quality and cost-effective laboratory and regulatory services to the government, institutions, private sector and the general public for the purpose of safeguarding human health, environment and for execution of justice. One of its main objectives is to contribute to the protection of the environment and health of people of Tanzania, by participating in the establishment of integrated chemicals management systems and regulating consumer and industrial chemicals. GCLA perform laboratory analysis of pharmaceutical products to conformity of national and international standards.

National Health Quality Laboratory Assurance Training Centre (NHLQATC)

NHLQATC has been established since 2008 under the MOHCDGEC for the purpose of improving quality of laboratory services all over the country. The NHLQATC is accredited under IEC/ISO 15189:2012 Medical laboratories requirements for quality and competence by Southern African Development Community Accreditation Services (SADCAS) in 2014 with certificate number MED 001.

Some of the services provided include:

1. Certification of biosafety cabinet to verify integrity equipment so as to provide protection for personnel, product and environment.
2. Laboratory diagnostic services for patient management and research purposes.
3. Work as an advisory and specialist in outbreak situations as well as offering required laboratory   support during outbreaks.
4. Research and evaluation to ensure the accuracy and reliability of test results from specific test methods and testing equipment.
5. Training and facilitation of public health laboratory science to in service personnel.
6. Quality assurance and compliance; oversee all medical laboratory functions in Tanzania.

For more information on regulatory departments and quality control laboratories’ contact details, please see the following links: 4.1 Government Contact List and 4.3 Laboratory and Quality Testing Company Contact List.