Africa-Press – Tanzania. TANZANIA Medicines and Medical Devices Authority (TMDA) said its commitment to ensure Tanzanians get safe, healthy, and quality products is now paying off ever since it invested in infrastructure and modern diagnostic equipment.
The achievement, buoyed by its foolproof laboratory system, has also been recognized by the World Health Organization and given accreditation. (WHO Prequalification Status\iso1/IEC 17025:2017 Accreditation).
“It is a success for us to increase the number of laboratories from two to three and also to see the increase in small laboratories (Min lab kits ) from 25 to 27, and due to that, the number of samples of controlled products has increased from an average of 800 in 2021 to 5,700 in 2025,” said the Director of Laboratory Services, Dr Danstan Shewiyo.
Dr Shewiyo told a team of editors who visited the TMDA laboratories in the Western regions of Tanzania that the authority has a special task to ensure that medicine and medical devices used in the country are clean, healthy, and safe for the health of people in the community.
He says, In order to be successful, TMDA is capable of using a different method including using laboratory, inspection, to create a system of giving out information, putting laws and so on.
Among the laws enacted are the Medicines and Medical Devices Act, Chapter 219.
According to Dr Shewiyo, TMDA has three laboratories, which are the Main Laboratory located in the Headquarters Sub-Office, Dar es Salaam, the Lake Zone Laboratory located in the East Lake Zone Office building in Mwanza Region and the laboratory located in the Headquarters offices, Dodoma.
He commended both the infrastructure and modern diagnostic equipment, saying both have been recognized by the World Health Organization and given accreditation.
“It is a success for us to increase the number of laboratories from two to three and also to see the increase in small laboratories (Min lab kits ) from 25 to 27 and due to that, the number of samples of controlled products has increased from an average of 800 in 2021 to 5,700 in 2025.
He explained that the responsibilities of the laboratories are to conduct laboratory examinations of samples of medicines and their raw materials, medical devices, and reagents.
“By using these laboratories, we conduct research related to controlled products, prepare and provide training to various employees and stakeholders, and perform other tasks according to the instructions of the authorities, where in carrying out these specified responsibilities, the laboratories contribute to ensuring the safety, quality, and effectiveness of medicines, medical devices, reagents, and vaccines.
Dr Shewiyo said that laboratory services have spread across the country, and they also have plans to continue expanding laboratory services so that services are closer to the citizens.
Other achievements made on the laboratory side, he says, are the increase in the number of testing experts in the laboratory from 28 in 2021 to 42 in 2025.
“The laboratory has continued to be the eye of the Ministry and the government in general in ensuring quality, safety, and efficiency. It has invested sufficiently in sample testing, so we invite stakeholders to contact TMDA to obtain laboratory services,” emphasizes Dr Shewiyo.
Sample examination
Regarding the availability of samples tested in these laboratories, Dr Shewiyo says they conduct inspections in markets, product registration, product quality monitoring in the market (Post marketing surveillance) and customers outside the jurisdiction and abroad, customs centers where Hamishika Laboratories are also used.
He says the success rate of samples of all controlled products over the past four years has continued to improve, with the 2021/2022 year rate being 91 percent, 2022/2023 year rate being 98.7 percent and 2023/2024 year rate being 99.7 percent.
“This investigation has been carried out on product samples in large and small laboratories, and the expertise of the testers we export depends on the agreements with the relevant countries. For those countries with which we have agreed to exchange experience, they are not paid, except for those with whom there is no agreement; they pay, $ 800 per head.
In terms of customs centers, the Western Zone Manager, Christopher Migoha, notes that the number of samples in the Western Zone has increased from 65 in 2021/22 to 247 in 2024/25.
“Also in the region, there is an increase in the issuance of permits for drugs of a narcotic nature, the value of drugs that do not meet the criteria has continued to decline, this means that these products are decreasing in the market, Strengthening cooperation with the media in the Western Zone and the Society still needs accurate information on drugs and medical devices, the media has this role,” he emphasizes.
TMDA in implementing the Industrial Policy, the Director of Human Medicines and Livestock, Dr Yonah Mwalwisi, says Tanzania imports more than 80 percent of its medical products from abroad, which he said is important to create an environment that attracts investment in industrial construction.
He says the number of industries has increased from 13 in 2020 to 18 and there is also an increase in the number of medical devices produced by local industries.
Six industries produce veterinary drugs, but it is still on a small scale (small-scale production).
Adverse reaction reporting
The Authority has established an electronic system known as the ADR Reporting Tool for reporting adverse drug reactions using mobile phones or computers and by sending a text message to the number *152*00#.
Speaking about reports of adverse reactions to medicines and medical devices, the Director of Medical Devices and Reagents, Dr Kisa Mwamwitwa says there is an increase in the reporting of adverse reactions from 5,132 in 2021 to 15,623 in 2025.
“Product monitoring is being carried out in the market to determine if there are substandard or unregistered products on the market, and for reporting, there is a voluntary method as well as a method of close monitoring of medical products immediately after they are put into use.
Dr Mwamwitwa says that due to reporting, the safety monitoring systems for medicines, medical devices, and reagents have improved significantly.
Regarding the safety of informants, Dr Mwamwitwa says there is an internal procedure to protect them so they do not have to worry about their safety.
“A medicine or medical device that is registered and certified by the authorities is safe, and we collaborate with manufacturers at all stages of production, where Tanzania also sells medicines to various countries such as Rwanda, Burundi, Uganda, Kenya and others.
She says the process involves receiving information, conducting assessments and investigations, taking corrective or preventive actions, sensitizing health care providers, monitoring complaints about substandard medicines and medical devices, and providing education to the community through various channels, including the media.
She says they ensure they maintain relationships with the media in the entire issue of providing information to the community, while the successes achieved through this partnership are increasing followers on social media.
“We bank heavily on the media to provide accurate information to citizens on the quality of medicines and medical devices, so journalists should continue to encourage the public to provide information on the use of substandard products.
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