The “Building Resilient Research Ethics, Diagnostics and Medicines regulatory capacity during routine and public health emergency periods” by acronym “BREEDIME”.

From July 2023, TMDA, as Scientific Lead, has been implementing a 36-month Project called “Building Resilient Research Ethics, Diagnostics, and Medicines Regulatory capacity during routine and public health emergency periods” by the acronym “BREEDIME” under EDCTP3 Global Health Funding. The Project is implemented by a total of nine (9) consortium members, including Zanzibar Food and Drugs Agency (ZFDA), Rwanda Food and Drugs Authority (Rwanda FDA), Kilimanjaro Christian Research Institute (KCRI), Muhimbili University of Health and Allied Sciences (MUHAS), National Institute for Medical Research (NIMR), Zanzibar Health Research Institute (ZAHRI), The University Court of The University of St. Andrew (UStAn), United Kingdom and Karolinska Institutet (KI), Sweden.

The main objective of the project is to strengthen clinical trials oversight, ethical review processes, and post-marketing surveillance of therapeutics, vaccines, diagnostics, and critical medical devices.

The specific objectives of the BREEDIME project are: -

1. To build capacity for rapid evaluation of therapeutic or vaccine trial protocols during a public health emergency;
2. To strengthen the regulatory framework and capacity to evaluate clinical trials for in vitro diagnostic and critical medical devices;
3. To establish a regulatory and ethical framework for health data access and sharing in normal and public health emergency periods
4. To strengthen capacity for post-market evaluation and appraisal of medicines and medical devices.
5. To create South-South benchmarking and mentorship on clinical trials oversight and medicines regulatory capabilities.

Project Implementation Progress: -

The Project has a total of 26 deliverables, and 19 deliverables have been completed, while seven (7) are ongoing. The implemented deliverables are: -

1. Launching of the project.
2. Establishment of Project Website.
3. Guidance and or algorithm in response to Evaluation and comments during an emergency outbreak in place.
4. Guidelines and SOP for the evaluation of therapeutic and vaccine trials in a period of public health emergency.
5. Baseline assessment for performance evaluation of diagnostics and critical medical devices.
6. Guidance documents for applicants and manufacturers on conducting a performance evaluation of diagnostic test kits.
7. Developing specific protocols for conducting performance verification studies for selected diagnostic test kits used for testing COVID-19, HIV, Hepatitis, Syphilis, TB and Malaria.
8. Performance evaluation of diagnostics and critical medical devices.
9. Data management Plan developed.
10. Update the Data Management Plan developed.
11. Post-marketing protocol and plan developed based on risk assessment of the medical products circulating on the market.
12. Sample collection and product information review (PIR).
13. Training needs assessment for therapeutic and vaccine protocol evaluation.
14. Preparation of training curriculum and materials for assessors.
15. Training of clinical trial assessors on in vitro diagnostics and medical device clinical trial evaluation.
16. Training on rapid evaluation of therapeutic or vaccine trial protocol during a public health emergency.
17. Customization of a short ethics course for the Rwanda FDA.
18. Exploitation and Dissemination Plan.
19. Updated Exploitation and Dissemination Plan.

The ongoing deliverables are: -

1. Awareness creation on the existence of the BREEDIME project.
2. Joint evaluation of clinical trial applications.
3. Post-approval joint inspections of clinical trial sites.
4. Monitoring and evaluation of the project.
5. Stakeholders' forum for dissemination of Project reports.
6. Establishing a regulatory framework on health data and material sharing during the emergency periods.
7. Regulatory capacity building, sharing scientific experience within the consortium countries.

Bioethics Training Workshop at Rwanda Food and Drugs Authority (Rwanda FDA), facilitated by Kilimanjaro Clinical Research Institute (KCRI), Tanzania - 22nd April 2024, Opening Day.

Trainers and Participants with their Certificates during the last day of training on the Bioethics course in Rwanda on April 26, 2024.

Project Launching, Landmark Hotel, Dar es Salaam.

Group Photo of TMDA Director General (fourth from the right – front) and training Participants – during training of assessors on clinical investigation of medical devices, Morogoro.

For more information about BREEDIME Project, click here...

In June 2024, TMDA joined the African Union Smart Safety Surveillance (AU-3S) Project. The Project is designed to strengthen pharmacovigilance systems in Africa, including the establishment of an Africa database for pooling together reports of adverse drug reactions and adverse events following immunisation to enhance signal detection and evidence generation in the African context.

Currently, the Project is being implemented by 21 African countries, namely Ethiopia, Ghana, Kenya, Nigeria, South Africa, Republic of Congo, Egypt, Mozambique, Rwanda, Senegal, Tanzania, Uganda, Botswana, Burkina Faso, Cape Verde, Gabon, Gambia, Namibia, Tunisia, Zambia and Zimbabwe.

The Project targets the following priority products; (i) Antiretroviral medicines (Abacavir/dolutegravir/lamivudine, Cabotegravir, Dolutegravir, Dolutegravir/lamivudine, Dolutegravir/lamivudine/tenofovir, Dolutegravir/rilpivirine and Rilpivirine), (ii) Anti-tuberculars (Pretomanid and Bedaquiline), (iii) Polio vaccines (Novel oral polio vaccine type 2 (nOPV2), (iv) Malaria Vaccines, (R21/Matrix Mosquirix), (v) Mpox vaccine (MVA-BN) and (vi) COVID-19 Vaccines (Janssen, AstraZeneca, Moderna, Pfizer, Sputnik, Sinopharm). Furthermore, the database for sharing of safety data called Afrivigilance has been established and is being utilised by all the member states, including Tanzania.

In strengthening the pharmacovigilance system in Tanzania, the Project is implemented for two (2) years from 1st July 2024 to 30th June 2026 and is intended to accomplish the following five (5) objectives: -

1. To reinforce the reporting of adverse events by the community and healthcare providers.
2. To improve the investigation and assessment of serious adverse events.
3. To strengthen the process of signal detection and management.
4. To enforce compliance with pharmacovigilance regulations by marketing authorization holders (MAH).
5. To strengthen pharmacovigilance centres at the regional level.

Project Deliverables and Progress: -

The Project has a total of 22 deliverables; 10 deliverables were implemented in 2024/25, and 12 are scheduled for 2025/26. The completed deliverables are: -

1. Training and sensitisation on reporting of adverse events to 64 healthcare workers from 16 District Hospitals.
2. Community sensitisation on reporting of adverse events in 7 districts.
3. Upgrading the Safety Quality Reporting Tool (SQRT).
4. Requirements gathering and validation for linkage of TMDA safety data to the AU-3S Data Integration and Signal Detection (DISD) of the Afrivigilance Hub.
5. Linkage of TMDA SQRT safety data to the AU-3S Data Integration and Signal Detection (DISD) of the Afrivigilance system.
6. Training on Upgraded SQRT, data handling and evaluation to 16 zonal PV focal Persons.
7. Developing Guidelines for signal detection and management.
8. Procurement and Distribution of Computers.
9. Pharmacovigilance Training to 32 public health programme coordinators from 10 regions.
10. To develop Guidelines for Operationalisation of pharmacovigilance centres.

The deliverables to be implemented in 2025/26 are: -

1. To conduct a causality assessment of both serious and non-serious adverse events and commissioning to VIGIBASE.
2. To conduct training on the investigation of serious adverse events to 5 teams from 5 Zonal hospitals.
3. To conduct Signal Detection of adverse events reported to the Authority.
4. To conduct a causality assessment of Serious adverse events.
5. To conduct Training on Signal Detection and management to 10 TMDA Staff.
6. To conduct training on pharmacovigilance inspection for 15 GVP inspectors.
7. To conduct pharmacovigilance inspections in 40 Marketing Authorisation Holders.
8. To conduct an assessment of the received Periodic Safety Update reports (PSURs).
9. To conduct an assessment of the received Risk Management Plan (RMP) reports.
10. To conduct training for 36 pharmacovigilance centres' focal personnel.
11. To conduct supportive supervision to 16 regional pharmacovigilance centres.
12. To conduct one (1) stakeholder meeting for pharmacovigilance activities

Guest of Honour Dr. Best Magoma, Regional Medical Officer – Morogoro, officiating the training of Public Health Program Coordinators conducted at JKT Umwema Conference Centre in Morogoro Municipality.

Ms. Fausta Nguzo, TMDA ICT Officer, is handing a desktop computer to a pharmacist at Iringa Regional Referral Hospital.

Mr. Augustino Malamsha, Communication and Public Education Officer, TMDA Northern Zone, during a community engagement session held in Mswakini Ward, Monduli DC.

A Focused Group Discussion is going on during the development of Guidelines for Operationalisation of Pharmacovigilance Centres, conducted at TMDA Northern Zone Conference Centre in Arusha City..

Group photo of participants at Magadu conference centre in Morogoro Municipality during the training of pharmacovigilance task force from District Hospitals.

Training on upgraded SQRT to TMDA Staff was conducted at Margaret Ndomondo Conference Centre at TMDA, Eastern Zone Office, Dar es Salaam.

For more detail about AU-3S Project, click here...

RER-CTO stands for Reinforce the Ethical and Regulatory Ecosystem for the Transformation of Clinical Trials Oversight in Ethiopia, Tanzania and beyond.

The project duration is a 36-months (3-year), since Novemba, 2024.

The project aims to achieve excellence and harmonization in ethics and regulatory functions among the national regulatory authorities (NRAs) and national ethics committees (NECs) in Ethiopia and Tanzania in clinical trial oversight. The RER-CTO project is funded by the Global Health EDCTP3 Joint Undertaking (Global Health EDCTP3).

For more information about the RER-CTO Project, click here...

This is a two-year (24-month) project that started on 1 October 2024 and will end on 30 September 2026.

The Global Grand Challenges on Strengthening African National Regulatory Authorities’ data systems to enhance and track performance aims to improve transparency and timely regulatory decision making by digitizing, automating and enhancing of sub-optimal existing data systems for capturing and reporting key data and metrics in the key regulatory functions for products marketing authorization, regulatory inspection and clinical trials controls oversight. The project is funded by the Gates Foundation.

The East African countries regulatory authorities participating in the Grand Challenge Project are TMDA (Tanzania), NDA (Uganda), EFDA (Ethiopia) and RFDA (Rwanda), with TMDA) being the lead NRA.

For more information about the Global Grand Challenges, click here...

The implementation schedule for Phase 2 of the SLL program is 1 year, from 13th February 2025 to 31st December 2025.

The Saving Lives and Livelihoods (Phase II) program aims to strengthen healthcare delivery and patient safety through enhanced pharmacovigilance practices in Tanzania. The program is funded by the Mastercard Foundation through Africa CDC. This phase builds on the successes of previous initiatives and aligns with the objectives set forth by the Tanzania Medicines and Medical Devices Authority (TMDA).

For more information about the Saving Lives and Livelihoods (Phase II) program, click here...

PROFORMA stands for Pharmacovigilance infrastructure and post-marketing surveillance system capacity building.

The project started in March 1, 2018 and ended with a final closure symposium held on December 19, 2024 in Stockholm.

PROFORMA was a consortium between academia and regulatory authorities from four (4) African countries; Ethiopia, Kenya, Tanzania, and Rwanda and other international collaborators including Karolinska Institutet (Sweden) and WHO collaborating Centre’s in Pharmacovigilance Centre-Lareb, Netherland. The initiative aimed to bolster pharmacovigilance in Ethiopia, Kenya, Rwanda, and Tanzania by building sustainable capacity for post-marketing surveillance of medicines, particularly in scenarios like mass drug administration and clinical trials.

For more information about PROFORMA Project, click here...

PAVIA stands for PhArmacoVIgilance Africa (PAVIA).

The project started in 2018 with a kick-off meeting in Dar es Salaam, Tanzania and ended with endline assessments in 2022 and a final webinar for researchers in 2023

PAVIA was a consortium that was funded by the European Developing countries Clinical Trials Partnership (EDCTP2 – grant number 1627 PAVIA CSA2016S). The PAVIA project aimed to strengthen pharmacovigilance in four African countries: Ethiopia, Nigeria, eSwatini, and Tanzania for the introduction of new drug a treatment regime for Multidrug-resistant Tuberculosis.

For more detail about PAVIA Project, click here...

ASCEND Project was a collaborative project funded by the European and Developing Countries Clinical Trials Partnership (EDCTP), which involved seven (7) different consortium members from Tanzania Mainland, Zanzibar and the United Kingdom. The consortium members were: Tanzania Medicines and Medical Devices Authority (TMDA), Muhimbili University of Health and Allied Sciences (MUHAS), National Institute for Medical Research (NIMR), The Good Samaritan Foundation, Kilimanjaro Christian Medical Centre (GSFKCMC), The University Court of the University of St Andrews (USTAN), Zanzibar Food and Drug Agency (ZFDA), Zanzibar Health Research Institute (ZAHRI. Tanzania Medicines and Medical Devices Authority (TMDA) was the leading organization that coordinated the ASCEND Project with Dr. Adam Fimbo as a Principal Investigator. The project was implemented for 38th months from 1st November to 30th December 2023.

Project Objectives

Main Objectives

To advance Tanzania’s clinical research oversight and pharmacovigilance capacities to meet 21st-century challenges in research and development, public health emergencies and healthcare.

Specific Objectives

1. To increase efficiency and quality of reviews and inspections of clinical trials conducted in Tanzania.
2. To increase community awareness of research ethics and ADRs reporting.
3. To build the capacity of the Zanzibar National Health Research Ethics Committee and the Food and Drug Authority.
4. To adopt, domesticate and implement the AVAREF guidelines for clinical trials oversight.
5. To increase north-south and south-south experience sharing and harmonisation through networking.
6. To improve the capacity of TMDA-MUHAS RCORE for medicines evaluation and registration.

The project implemented different deliverables through different work packages, and the most significant achievements of the project by Tanzania Medicines and Medical Devices Authority (TMDA) include: -

1. Domestication and implementation of AVAREF guidelines.
2. Development of an electronic system for submission and review of clinical trial applications.
3. Training researchers on advocacy on laws, regulations and ethical issues pertaining to clinical trials.
4. Establishment of a Pharmacovigilance community engagement Model to work with TMDA, NIMR, and KCRI, and use the model to conduct community sensitization in the Dodoma region and Zanzibar.
5. Publication on “Lessons learnt from ASCEND project” open access: published 12th August 2024, Volume 21, article number 54,(2024): “Lessons from enriching Tanzania’s clinical research ethics, clinical trial oversight and Pharmacovigilance through ASCEND project”

For more information, go to the website: https://ascend.tmda.go.tz/,
Instagram: ASCENDEDCTP