The short course on In-Vitro Diagnostics and Medical Devices Investigation for the BREEDIME project concluded with a certificate ceremony at the Centre for Distance Learning in Morogoro, Tanzania, on 24th January 2025. The training was coordinated by Muhimbili University of Health and Allied Sciences (MUHAS) in partnership with the Tanzania Medicines and Medical Devices Authority (TMDA).
The official opening of the short course on In-Vitro Diagnostics and Medical Devices investigation for BREEDIME project was held at the Centre for Distance Learning in Morogoro, Tanzania. The training was organized by Muhimbili University of Health and Allied Sciences (MUHAS) in collaboration with Tanzania Medicine and Medical Devices Authority (TMDA).
The BREEDIME training on Medical Devices is currently ongoing at the Centre for Distance Learning in Morogoro,Tanzania. Organized by Muhimbili University of Health and Allied Sciences (MUHAS) and Tanzania Medicine and Medical Devices Authority (TMDA) the training focuses on the Clinical Investigation of Medical Devices and In-Vitro Diagnostic Assessment and will run from January 20th - 24th, 2025.
The first BREEDIME Annual Consortium Meeting took place on November 18–19, 2024, at the Golden Tulip Airport Hotel in Zanzibar.
“Building Research Ethics, Diagnostics and Medicines Regulatory Capacity during routine and Public health emergency periods (BREEDIME) Project" held its annual consortium meeting on 18th - 19th November 2024 in Zanzibar to discuss the implementation status of the project since it started in August 2023
The first BREEDIME Annual Consortium Meeting took place on November 18–19, 2024, at the Golden Tulip Airport Hotel in Zanzibar.
The BREEDIME project main objective is to strengthen regulatory affairs in area of ethical review processes, clinical trials control, assessment, and post marketing evaluation of therapeutics, vaccines, diagnostics, and critical medical devices
ABOUT THE PROJECT
The “Building Resilient Research Ethics, Diagnostics and Medicines regulatory capacity during routine and public health emergency periods” by acronym “BREEDIME” Project is 36 months project involving 9 consortium members namely;
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- Tanzania Medicines and Medical Devices Authority (TMDA)
- Karolinska Institutet (KI)
- Zanzibar Food and Drug Agency (ZFDA)
- BREEDIME Rwanda Food and Drugs Authority (Rwanda FDA)
- Kilimanjaro Clinical Research Institute (KCRI-GSF KCMC)
- Muhimbili University of Health and Allied Sciences (MUHAS)
- National Institute for Medical Research (NIMR)
- Zanzibar Health and Research Institute (ZAHRI) and
- St. Andrews University, Scotland - UK.
GOALS AND OBJECTIVES
To strengthen regulatory affairs in area of ethical review processes, clinical trials control, assessment, and post marketing evaluation of therapeutics, vaccines, diagnostics, and critical medical devices
Specific Objectives:
- To build capacity for rapid evaluation of therapeutic or vaccine trial protocol during public health emergency
- To strengthen regulatory framework and capacity to evaluate clinical trials for in vitro diagnostic and critical medical devices
- To establish a regulatory and ethical framework for health data access and sharing in normal and public health emergency periods
- To strengthen capacity for post-market evaluation and appraisal of medicines and medical devices
- To create South-South benchmarking and mentorship on clinical trials oversight and medicines regulatory capabilities
WORK PACKAGES
The BREEDIME Project has eight (8) work packages and each is led by different consortium institution as described below;
| WPs | WP Title | Lead Institution |
|---|---|---|
| 1 | Therapeutic or vaccine trial protocol evaluation during public health emergency | Rwanda FDA |
| 2 | In-vitro diagnostics and critical devices | TMDA |
| 3 | Health data management during emergency period | NIMR |
| 4 | Post marketing surveillance and appraisal | ZFDA |
| 5 | Training | MUHAS |
| 6 | Scientific leadership and networking | TMDA |
| 7 | Project management and coordination | KI |
| 8 | Communication and dissemination | KCRI-GFS KCMC |
SHORT FACTS
| Project Title: | Building resilient research ethics, Diagnostics, and medicines regulatory capacity during routine and public health emergency periods with acronym of “BREEDIME”. |
Acronym: BREEDIME
Project start date: 01st June, 2023
Duration: 36 months
| Collaborative Institutions: | Tanzania Medicines and Medical Devices Authority (TMDA), Karolinska Institutet (KI), Zanzibar Food and Drug Agency (ZFDA), BREEDIME Rwanda Food and Drugs Authority (Rwanda FDA), Kilimanjaro Clinical Research Institute (KCRI), Muhimbili University of Health and Allied Sciences (MUHAS), National Institute for Medical Research (NIMR), Zanzibar Health and Research Institute (ZAHRI) and The University of St. Andrews (UStAn). |
Grant amount: EUR 599 637.50
Coordinated by: KAROLINSKA INSTITUTET
Funding Organization: EDCTP
Consortium Members
Tanzania Medicines and Medical Devices Authority (TMDA) is an Executive Agency under the Ministry of Health (MOH). TMDA which was formerly known as Tanzania Food and Drugs Authority (TFDA) was established in 2003 after enactment of the Tanzania Food, Drugs and Cosmetics Act, Cap 219 by the Parliament. 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. Read More
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. Read More
Karolinska Institutet (KI) is a renowned medical university and research institution located in Stockholm, Sweden. It is one of the world's leading centers for medical and life sciences research and is particularly well-known for its contributions to the field of medicine and the Nobel Prize in Physiology or Medicine, which it awards annually. Here are some key points about Karolinska Institutet
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The Zanzibar Food and Drug Agency (ZFDA) operates as a regulatory body under the Ministry of Health in Zanzibar, with the primary goal of safeguarding the safety, quality, and efficacy of various products, including food, medicines, cosmetics, medical devices, and diagnostics. The agency was established under the Zanzibar Food, Drug and Cosmetics Act, which empowers it to enforce the necessary regulations for public safety and interest. As a semi-autonomous entity, ZFDA’s critical function involves regulating products from importation, transportation, distribution, and sale, ensuring their safety for human use. ZFDA is committed to its mandate of protecting the public by ensuring the safety, quality, and efficiency of the products they consume or use. Read More
Rwanda Food and Drugs Authority hereafter designated as the “Authority”, was established by the law Nº 003/2018 of 09/02/2018 determining its mission, organization and functioning. The mandate of the Authority is to protect public health through regulation of human and veterinary medicines, vaccines and other biological products, processed foods, poisons, medicated cosmetics, medical devices, household chemical substances, tobacco and tobacco products.
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Kilimanjaro Clinical Research Institute (KCRI) is an academic centre for evidence based health interventions. We initiate and conduct medical research to develop evidences for interventions and provide research training and necessary research logistics to collaborators and partners. We collaborate according to the four C’s of our institute which are conduct, contract, coordinate and consult. KCRI forms the third pillar of the Good Samaritan foundation next to health services and training.
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The Muhimbili University of Health and Allied Sciences (MUHAS) started as the Dar es salaam medical school in 1963. The school then transformed into the faculty of medicine of the university of Dar es salaam that in 1991 was upgraded and became a college–the Muhimbili University College of Health Sciences (MUCHS).
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The National Institute for Medical Research (NIMR) is the largest public health research institution in Tanzania. It was established by the Parliament Act No. 23 of 1979 as a parastatal organization under the Ministry of Health. The establishment of NIMR was in recognition by the government of the need to generate scientific information required in the development of better methods and techniques of enhancing disease management, prevention and control in the country.
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Zanzibar Health research institute is the leading governmental health research institute in Zanzibar. Zahri is responsible in conducting and promoting, Inspect institute of site that was approve to conduct health research health research, suggesting policy development, approval of ethical clearance for health research conducted in Zanzibar. We are responsible on ensuring health research proposals are reviewed to safeguard the dignity, rights, safety and wellbeing of research participants.
We develop close collaboration with both governmental and private institute, local and international institute in conducting health research in Zanzibar.
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The University Court of the University of St. Andrews, often referred to simply as "University Court" or "UStAn," is the governing body responsible for overseeing and managing the University of St. Andrews, one of the oldest and most prestigious universities in Scotland and the United Kingdom
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EDCTP is an EU-funded partnership between institutions mandated by the governments of 15 European and 25 African countries. Launched in 2003 and renewed in 2014 with funding through to 2024, EDCTP has been the focal point for EU support for global health research in Africa, and a visible sign of the EU’s commitment to the Millennium Development Goals and more recently the Sustainable Development Goals. Through its evolution, EDCTP has been driven by the infectious disease priorities of sub-Saharan Africa and the need to develop African countries’ capacity to collectively address these priorities into the future.
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LEADERS
Project Coordinator
Prof. Eleni Aklillu,
Karolinska Institutet (KI)
Scientific Leader
Mr. Adam M. Fimbo,
Tanzania Medicines and Medical Devices Authority (TMDA)
OUR ACHIEVEMENTS
The following deliverables have been completed;
| Work Package No | Deliverable No | Deliverable Name | Description | Lead Beneficiary | Due Date | Status |
|---|---|---|---|---|---|---|
| WP1 | D1.1 | Guidance/algorithm in response to evaluation | To develop Guidance/algorithm to be followed in response to evaluation of therapeutic and vaccines trials protocol and comments during an emergency outbreak | Rwanda FDA | 31 Oct 2023 | Completed |
| WP1 | D1.2 | Guidelines and SOP for evaluation | Guidelines and SOP for the evaluation of therapeutic and vaccine trials in a period of public health emergency | Rwanda FDA | 31 Jan 2024 | Completed |
| WP2 | D2.1 | Baseline assessment report | The baseline assessment for evaluation of diagnostics and critical medical devices will be conducted and report should be prepared | NIMR | 30 Nov 2023 | Completed |
| WP2 | D2.2 | Developing guidance documents for conducting performance evaluation | Developing guidance documents for applicants and manufacturers on requirements for conducting a performance evaluation of diagnostic test kits | TMDA | 31 May 2024 | Completed |
| WP2 | D2.4 | Developing Protocols for conducting performance verification studies | Developing specific protocols for conducting performance verification studies for selected diagnostics test kits used for testing Covid-19, HIV, Hepatitis, Syphilis, TB and Malaria and developing other working tools such as SOPs, flow charts | TMDA | 31 May 2024 | Completed |
| WP3 | D3.2 | Data Management Plan | Data management plan will be developed | NIMR | 30 Nov 2023 | Completed |
| WP4 | D4.1 | Post-marketing protocol and plan developed | Post-marketing protocol and plan developed based on risk assessment of the medical products circulating on the market | ZFDA | 31 Mar 2024 | Completed |
| WP5 | D5.1 | Training Needs Assessment | Training needs assessment for both therapeutic and vaccines protocol evaluation, and for performance evaluation of in-vitro diagnostics and critical medical devices will be conducted for staff from TMDA, ZFDA, Rwanda FDA, NIMR and ZAHRI | MUHAS | 31 Mar 2024 | Completed |
| WP5 | D5.2 | Customization of short ethics course for Rwanda | Short ethics course will be customized for Rwanda FDA | GSF KCMC | 30 Sep 2024 | Completed |
| WP8 | D8.2 | Launching of the project | The project will be launched to create awareness on its objectives and other issues pertaining to the project | GSF KCMC | 31 Jul 2023 | Completed |
| WP8 | D8.4 | Website of the project | Website of the project will established | TMDA | 31 Aug 2023 | Completed |
| WP8 | D8.5 | Exploitation and Dissemination plan | Exploitation and dissemination plan developed | GSF KCMC | 30 Nov 2023 | Completed |
DELIVERABLES
PROJECT DELIVERABLES AND TIMELINES
| Work Package No | Deliverable No | Deliverable Name | Description | Lead Beneficiary | Due Date |
|---|---|---|---|---|---|
| WP1 | D1.1 | Guidance/algorithm in response to evaluation | To develop Guidance/algorithm to be followed in response to evaluation of therapeutic and vaccines trials protocol and comments during an emergency outbreak | Rwanda FDA | 31 Oct 2023 |
| WP1 | D1.2 | Guidelines and SOP for evaluation | Guidelines and SOP for the evaluation of therapeutic and vaccine trials in a period of public health emergency | Rwanda FDA | 31 Jan 2024 |
| WP1 | D1.3 | Joint evaluation of clinical trials | A joint evaluation of clinical trials applications which are Completed to the Regulatory Authority and Ethics Committee will be conducted. Joint evaluation will be conducted by a group of assessors from TMDA, ZFDA, Rwanda FDA, NIMR, ZAHRI. Conducting joint evaluation of clinical trial protocols will reduce waiting time | TMDA | 31 May 2025 |
| WP1 | D1.4 | Post-approval Joint inspections of clinical trials | Conducting post-approval joint inspections of clinical trials to ensure they are conducted ethically. Joint inspection between TMDA, ZFDA, Rwanda FDA, ZAHRI and NIMR will be done. The TMDA and NIMR twining team of inspectors will be created and assigned for a site inspection of the approved clinical trials. The inspection will be conducted at 18 and 30 months. The inspections will also be done in other consortium countries. | TMDA | 30 Nov 2025 |
| WP2 | D2.1 | Baseline assessment report | The baseline assessment for evaluation of diagnostics and critical medical devices will be conducted and report should be prepared | NIMR | 30 Nov 2023 |
| WP2 | D2.2 | Developing guidance documents for conducting performance evaluation | Developing guidance documents for applicants and manufacturers on requirements for conducting a performance evaluation of diagnostic test kits | TMDA | 31 May 2024 |
| WP2 | D2.3 | Performance evaluation of diagnostics and critical medical devices | Conducting performance evaluation of diagnostics and critical medical devices. The performance evaluation verification will be conducted by assessors | TMDA | 31 May 2025 |
| WP2 | D2.4 | Developing Protocols for conducting performance verification studies | Developing specific protocols for conducting performance verification studies for selected diagnostics test kits used for testing Covid-19, HIV, Hepatitis, Syphilis, TB and Malaria and developing other working tools such as SOPs, flow charts | TMDA | 31 May 2024 |
| WP3 | D3.1 | Establishing a regulatory framework on health data and material sharing during the emergency periods | A regulatory framework will be established on health data and material sharing during the emergency periods. Different guidelines will be developed and these will include guide for data collection tools (manual and electronic), data storage, accessing archived data for research, sharing data in-country and outside country. This will improve ethics requirements for health data and material access during emergency periods | NIMR | 30 Sep 2025 |
| WP3 | D3.2 | Data Management Plan | Data management plan will be developed | NIMR | 30 Nov 2023 |
| WP3 | D3.3 | Updated Data Management Plan | Update the Data Management Plan as needed during the project's progress | NIMR | 30 Nov 2024 |
| WP4 | D4.1 | Post-marketing protocol and plan developed | Post-marketing protocol and plan developed based on risk assessment of the medical products circulating on the market | ZFDA | 31 Mar 2024 |
| WP4 | D4.2 | Sample collections and perform product information reviews | Collecting samples from the market based on the approved sampling plan and product information review (PIR) will be conducted as per the established protocol. The results of Products information review (PIR) will be disseminated during stakeholders meeting Regulatory actions will be taken for those who will not comply with regulations | ZFDA | 31 Jan 2025 |
| WP5 | D5.1 | Training Needs Assessment | Training needs assessment for both therapeutic and vaccines protocol evaluation, and for performance evaluation of in-vitro diagnostics and critical medical devices will be conducted for staff from TMDA, ZFDA, Rwanda FDA, NIMR and ZAHRI | MUHAS | 31 Mar 2024 |
| WP5 | D5.2 | Customization of short ethics course for Rwanda | Short ethics course will be customized for Rwanda FDA | GSF KCMC | 30 Sep 2024 |
| WP5 | D5.3 | Preparation of training curriculum and materials for assessors | Preparation of training curriculum and materials for assessors will be done | MUHAS | 30 Sep 2024 |
| WP5 | D5.4 | Training of clinical trial assessors on in-vitro and medical devices CTs evaluation | Training of clinical trial assessors on in-vitro diagnostics and medical device clinical trial evaluation. The TMDA-MUHAS RCORE will be strengthened by conducting different trainings for reviewers, assessors and inspectors on evaluation and inspection of new trials of both emerging and re-emerging diseases in the emergency period. | MUHAS | 30 Nov 2025 |
| WP5 | D5.5 | Training on rapid evaluation of therapeutic or vaccine trial | Training on rapid evaluation of therapeutic or vaccine trial protocol during a public health emergency. Training and Technical support will be provided to the responsible personnel on clinical trials evaluation in consortium African countries for them to improve and respond fast in the evaluation of the protocol during emergencies. | MUHAS | 30 Nov 2025 |
| WP6 | D6.1 | Regulatory Capacity building of other SSA countries, and Sharing Scientific experience within consortium countries | Regulatory capacity building, Sharing scientific experience within the consortium countries. Benchmarking and mentoring of SSA countries will be conducted. | TMDA | 28 Feb 2026 |
| WP7 | D7.1 | Monitoring and Evaluation of the project | Monitoring and evaluation of the project will be done to ensure its smooth implementation. Resources of the project will be controlled to achieve specific project goals | KI | 31 May 2026 |
| WP8 | D8.1 | Awareness creation on the existence of the Project | Awareness creation on the existence of the BREEDIME project by using different forum and social media | GSF KCMC | 31 May 2026 |
| WP8 | D8.2 | Launching of the project | The project will be launched to create awareness on its objectives and other issues pertaining to the project | GSF KCMC | 31 Jul 2023 |
| WP8 | D8.3 | Dissemination of reports to all stakeholders | Dissemination of the reports to relevant stakeholders by conducting Stakeholders' forum annual project meetings including preparations for policy brief. The meeting will be convened to disseminate different information about the project and its progress and outcome. | GSF KCMC | 31 May 2026 |
| WP8 | D8.4 | Website of the project | Website of the project will established | TMDA | 31 Aug 2023 |
| WP8 | D8.5 | Exploitation and Dissemination plan | Exploitation and dissemination plan developed | GSF KCMC | 30 Nov 2023 |
| WP8 | D8.6 | Updated Exploitation and Dissemination Plan | Update the Exploitation and Dissemination Plan as needed during project's progress | GSF KCMC | 30 Nov 2024 |
Hope you got to know us better now!
Contact Us
Director General,Tanzania Medicines and Medical Devices Authority (TMDA),
PSSSF Building, Block T, 10th Floor,
P. O. Box 1253, Dodoma Or
P. O. Box 77150, Dar es Salaam
Phones: +255 22 2452108/2450512/2450751
Fax: +255 22 2450793
Hotline: 0800110084