SAHPRA undergoes AUDA-NEPAD in-country assessment

Pretoria, 07 October 2022 – The South African Health Products Regulatory Authority (SAHPRA) hosted the African Union Development Agency (AUDA-NEPAD) as part of the African Union’s Smart Safety Surveillance (AU-3S) programme.

African Union’s Smart Safety Surveillance (AU-3S) programme is aimed at strengthening the safety surveillance of priority health products across the African continent through efficiencies like technological innovation, pooling of resources, and work sharing. It was launched as a pilot in 2020 during the COVID-19 pandemic and mass roll-out of vaccination throughout the world. AU-3S continues piloting its approach on the safety surveillance of COVID-19 vaccines in five countries. These pilot countries are Ethiopia, Ghana, Nigeria, South Africa and Kenya – altogether comprising ~35% of Africa’s population. The AU-3S team works closely with the health products National Regulatory Authorities (NRAs) and Expanded Programmes on Immunisation (EPIs) from countries involved.

To support countries the AU-3S team has multiple initiatives, including four main programme solutions:

  • Promotion of electronic safety data collection through the Med Safety App to stimulate the reporting of adverse events following immunisation (AEFIs) or adverse drug reactions (ADRs). AU-3S provides support to regulatory authorities and immunisation programmes to successfully roll the tool out and ensure usage by both healthcare providers and the public.
  • Implementation and operation of a common African safety database known as the AfriVigilance system, to detect safety signals in combined cross-country data from countries involved in the AU-3S programme.
  • Establishment and operation of a multi-country group of safety experts, known as the AU-3S Joint Signal Management Group (AU-3S JSM Group), to validate, prioritise, and assess the cross-country signal reports from cross-country data.
  • Facilitation of capacity strengthening through: trainings covering end-to-end aspects of safety surveillance; AU-3S JSM Group Secretariat activities to strengthen national capabilities for signal detection; and the setting up of a super user network for countries in the programme to effectively use the Vigilance Hub.

These solutions are being developed by AUDA-NEPAD in conjunction with a working group that is comprised of members of the country health products regulatory authorities, members of the EPI programme, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as a key technical partner.

The main objectives of the on-site visit were to enhance ongoing efforts to harmonise the safety surveillance processes in South Africa. Focused discussion between SAHPRA, MHRA and AUDA-NEPAD on joint initiatives to support the South African Pharmacovigilance systems were held. Furthermore, interventions to enhance the Med Safety App web version were identified. These will facilitate reporting by healthcare professionals in South Africa and integration with other safety surveillance systems that will enhance and improve reporting in the country.

Officials in attendance from AUDA-NEPAD were Mr Hudu Mogtari, Mr Ladji Sedibe, Ms Victoria Nambasa, Ms Mercedes Leburu, Ms Nqobile Zwane, Ms Ellen Huruva, Ms Modupe Adeyemo, and Ms Victorine Mekesse. There were also representatives from MHRA namely, Ms Kendal Harrison, Mr Mick Foy, and Mr Phil Tregunno.

This meeting has managed to achieve its objectives and will provide a clearer direction towards the planning for Phase 2 of the AU-3S programme. The result will be an effective delivery of phase 2 targets and improved safety surveillance systems in the five (Ethiopia, Ghana, Nigeria, South Africa, and Kenya) participating countries as well as assured safety for African citizens.

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