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