The partnership, known as SPARC, brought together national regulatory authorities from Zimbabwe, Mozambique, and two other Southern African countries in a coordinated effort to reinforce drug safety systems. Its work was grounded in a simple recognition: clinical trials, however rigorous, cannot capture the full spectrum of real-world effects that emerge when a medicine reaches millions of patients. Building robust pharmacovigilance requires sustained commitments to funding, infrastructure, human capacity, and cross-country collaboration, elements that no single country can assemble alone.

SPARC’s approach unfolded in phases. The first phase mapped existing drug safety systems across the participating countries, revealing both strengths and gaps. The second phase moved into structured learning, with workshops that allowed regulators to share knowledge and identify areas for joint action. The third phase focused on building practical tools, including training materials for community health workers, who serve as a vital frontline layer in detecting adverse effects. This phased design reflected a deliberate strategy: rather than imposing a top-down framework, the partnership built capacity step by step, grounded in the realities of each country’s existing systems.

The workshops revealed striking differences in how the participating countries approached drug safety. Some had well-established systems with dedicated staff and clear protocols, while others relied on smaller teams with limited resources. These differences became an asset rather than an obstacle: regulators with stronger systems shared their experience, while those with emerging systems contributed fresh perspectives on building capacity from limited foundations. The exchange transformed variation into a source of mutual learning, grounded in the recognition that no single model fits every context.

One of the partnership’s most practical contributions was the development of training materials for community health workers. These frontline workers, embedded in communities and trusted by patients, serve as a vital layer in detecting adverse effects that might otherwise go unreported. The materials were tested with health workers in the participating countries, with evaluations confirming their value in building knowledge and confidence. This grassroots approach reflected a deliberate strategy: rather than relying solely on formal regulatory structures, the partnership built capacity at the community level, where real-world effects first emerge.

The partnership’s experience offers lessons for how collaborative drug safety oversight can be built across borders. First, mapping existing systems before designing interventions ensures that capacity building is grounded in real foundations rather than abstract models. Second, structured learning, with workshops that allow regulators to share knowledge, transforms variation between countries into a source of mutual benefit. Third, building practical tools, including training materials for frontline workers, extends protection beyond formal regulatory structures to the community level, where real-world effects first emerge.

Perhaps the most important lesson is that collaborative work to enhance drug safety is paramount in an era when misinformation about medicines spreads rapidly. Building robust pharmacovigilance requires sustained commitments to funding, infrastructure, human capacity, and cross-country collaboration, elements that no single country can assemble alone. The SPARC partnership demonstrates that when countries work together, grounded in the realities of their existing systems, they can build layers of protection that extend from formal regulatory structures to the communities where patients live.

Underreporting remains one of the most stubborn obstacles facing pharmacovigilance systems across sub-Saharan Africa. When adverse drug reactions go unreported, the safety signals that regulators depend on to refine prescribing guidance, update product labels, or withdraw dangerous products simply never materialize. The reasons are well documented: health workers may not know how to report, may fear blame, or may consider reactions an expected consequence of treatment rather than a reportable event. Patients, meanwhile, often lack any channel through which to voice concerns about the medicines they take. This is precisely why the SPaRCS project invested in a training package for community health workers on adverse drug reaction reporting, extending the reach of formal reporting systems into the communities where medicines are actually consumed.

The project’s participatory action learning approach deserves particular attention. Rather than importing a ready-made curriculum or a standardized assessment tool, the partners co-created their activities, drawing on the lived experience of regulators, pharmacovigilance centre staff, and public health officials in Namibia, Eswatini, Zimbabwe and South Africa. This method, rooted in the tradition of action research, treats the participants as co-producers of knowledge rather than passive recipients of external expertise. The mapping exercise that opened the project exemplified this ethos: by documenting the state of pharmacovigilance and clinical trials oversight in each country before designing interventions, the partners ensured that subsequent workshops and learning exchanges responded to actual gaps rather than assumed ones.

The distinction between pre-market and post-market regulatory functions helps explain why pharmacovigilance has historically been neglected. Regulatory strengthening initiatives have traditionally prioritized the capacity to issue marketing authorizations and license pharmaceutical premises, activities that are visible, measurable, and directly tied to the imperative of demonstrating that medicines are safe before they reach patients. Post-market surveillance, by contrast, operates continuously and invisibly, and its successes are often measured in harms that never occurred. Policymakers in low and middle-income countries frequently fail to recognize pharmacovigilance as a public health service in its own right, which in turn translates into chronic under-resourcing of the human and financial capacity that reporting systems require.

The COVID-19 pandemic sharpened awareness of this imbalance. The rapid rollout of vaccination programs across the continent demonstrated, sometimes painfully, that well-prepared pharmacovigilance systems are not a luxury but a prerequisite for maintaining public confidence in new medical products. The pandemic also exposed pre-existing disparities in access to health products between the Global North and the Global South, prompting renewed attention to pharmaceutical research, development and production within Africa. That renewed attention carries a regulatory corollary: as more medicines and vaccines are manufactured on the continent, the systems that oversee their safety in real-world use must mature in parallel.

Encouraging signs of maturation are already visible. Under the World Health Organization’s Global Benchmarking Tool, several African countries have reached maturity level 3, indicating a stable, well-functioning and integrated regulatory system. Ethiopia, Ghana, Nigeria, Rwanda, Senegal and Tanzania have achieved this level for medicines and vaccines, Egypt for both, and South Africa for vaccines. Zimbabwe, one of the SPaRCS partner countries, also functions at maturity level 3 for medicines. Regional harmonization initiatives, including those of the East African Community, the Southern African Development Community, ZaZiBoNa, ECOWAS and the Intergovernmental Authority on Development, have complemented these national gains by enabling joint assessments and shared post-marketing surveillance strategies. The recently founded African Medicines Agency, modeled on the European Medicines Agency, holds the potential to extend this harmonization to the continental level.

Within this broader landscape, the SPaRCS project, which commenced in April 2020 and ran for three and a half years, was led by the University of the Western Cape’s School of Public Health and School of Pharmacy in collaboration with the national regulatory authorities of Namibia, Eswatini and Zimbabwe and South Africa’s National Department of Health. The project deliberately built on existing relationships between the university team and its country partners, an approach that reduced the transaction costs of establishing trust and allowed the work to begin from a foundation of mutual familiarity. The partners convened participatory workshops and learning exchanges in two thematic areas, strengthening pharmacovigilance systems and clinical trials oversight, and shared challenges, field experiences and best practices across sub-national, national and regional settings.

Clinical trials oversight, the project’s second thematic pillar, is often overshadowed by pharmacovigilance in discussions of regulatory capacity, yet it is equally essential. Effective oversight of trials ensures not only the safety and efficacy of the products under investigation but also the scientific and ethical integrity of the research itself, which is critical for maintaining public trust. As pharmaceutical research and manufacturing expand across the continent, the demand for competent trial oversight will only grow, making the capacity built through initiatives like SPaRCS a timely investment.

The project’s most tangible legacy may prove to be institutional rather than technical. The regional platform created through SPaRCS provided the starting point for the Centre of Excellence for Pharmacovigilance in Southern Africa, launched at the end of 2024. Such a centre offers a durable home for the relationships, knowledge and training materials that the project generated, reducing dependence on the continued availability of project funding. Sustaining pharmacovigilance capacity ultimately requires exactly this kind of formal collaborative platform, backed by political will and predictable resources, so that the detection, assessment and prevention of adverse drug reactions becomes a permanent public health function rather than a time-limited project activity. The experience of the four partner countries suggests that when capacity building is grounded in existing relationships and co-created with those who will use it, the resulting systems are more likely to endure.

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

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

Article References: Viljoen, M., Khoza, S., Dheda, M., Chirinda, L., Shigwedha, F., Shimbulu, A., Nhlabatsi, S., Shongwe, N., Figueras, A., Ravinetto, R., & Bradley, H. (2026). Strengthening pharmacovigilance and regulatory capacity in Southern Africa (SPaRCS): achievements, experiences and lessons learned from a participatory action learning project. Frontiers in Drug Safety and Regulation, 6, Article 1765077. https://doi.org/10.3389/fdsfr.2026.1765077

Image Credits: AI Generated

DOI: 10.3389/fdsfr.2026.1765077

Keywords: Strengthening, pharmacovigilance, regulatory, capacity, Southern, Africa, SPaRCS, achievements, experiences, lessons, learned, participatory