Strengthening pharmacovigilance and regulatory capacity in Southern Africa (SPaRCS): achievements, experiences and lessons learned from a participatory action learning project

Effective regulatory systems play a critical role in improving access to safe, efficacious and quality medicines and vaccines. However, most regulatory and pharmacovigilance (PV) systems in sub-Saharan Africa (SSA) are still under-resourced and lack recognition of their public health service role, despite encouraging developments in several countries, and positive experiences of harmonization across the continent. The aim of Strengthening pharmacovigilance and regulatory capacities in four Southern African countries (SPaRCS), was to improve pharmacovigilance and clinical trials oversight in Namibia, Eswatini, Zimbabwe and South Africa. The project used a participatory action learning and co-creation approach and built on existing relationships with national regulatory authorities and PV centres in the four countries. Key activities included a mapping of PV and clinical trials oversight in the four partner countries; participatory workshops and learning exchanges in two thematic areas; Strengthening PV systems and Clinical trials oversight, and collaborative development of a training package for community health workers on adverse drug reaction reporting. Intentionally SPaRCS provided opportunities for partners in the four countries to develop relationships amongst those involved in PV and clinical trials oversight in the region. This included sharing of challenges, field experiences and best practices in a sub-national, national and regional setting. Strong commitment of country partners and the flexible learning and co-creation approach facilitated positive achievements. Strengthening PV and clinical trial oversight requires a multi-faceted approach involving the establishment of robust systems, addressing infrastructure and training gaps, integrating PV into public health programs and building formal collaborative platforms at regional level. The regional platform created by SPaRCS provided a starting point, for the establishment of the Centre of Excellence for Pharmacovigilance in Southern Africa (CEPSA) launched at the end of 2024.