Evidence map›Paper›PMID 42311280›Full record

ArticleFrontiers in drug safety and regulation2026

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

Michelle Viljoen, Star Khoza, Mukesh Dheda, Libert Chirinda, Frieda Shigwedha, Anna Shimbulu, SipheSihle Nhlabatsi, Nomsa Shongwe, Albert Figueras, Raffaella Ravinetto and 1 more

Abstract read
In one paragraph

Article in Frontiers in drug safety and regulation, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Michelle ViljoenSchool of Pharmacy, University of the Western Cape, Cape Town, South Africa.
Star KhozaSchool of Pharmacy, University of the Western Cape, Cape Town, South Africa.
Mukesh DhedaPharmacovigilance Centre for Public Health Programs, National Department of Health, Pretoria, South Africa.
Libert ChirindaPharmacovigilance and Clinical Trials Division, Medicines Control Authority of Zimbabwe, Harare, Zimbabwe.
Frieda ShigwedhaNamibia Medicines Regulatory Council, Ministry of Health and Social Services, Windhoek, Namibia.
Anna ShimbuluNamibia Medicines Regulatory Council, Ministry of Health and Social Services, Windhoek, Namibia.
SipheSihle NhlabatsiPharmaceutical Services, Ministry of Health, Mbabane, Eswatini.
Nomsa ShongwePharmaceutical Services, Ministry of Health, Mbabane, Eswatini.
Albert FiguerasIndependent Consultant, Barcelona, Spain.
Raffaella Ravinetto *Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.
Hazel Bradley *School of Public Health, University of the Western Cape, Cape Town, South Africa.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

capacity buildingclinical trialscollaborative partnershipcommunity health workerspharmacovigilanceregulationsafetySouthern Africa

Identifiers

PMID42311280
PMCPMC13270022

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.