ArticleJournal of pharmaceutical policy and practice2025
Evaluation of the implementation and the associated operating costs of a medicine regulatory harmonisation model in Africa: the case of ZaZiBoNa, a SADC work-sharing initiative.
Article in Journal of pharmaceutical policy and practice, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.
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Who cites it
3 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pharmaceutical regulatory harmonization in Africa: a scoping review of policy design, implementation approaches, and outcomes.Frontiers in medicine · 2026Pooled it
- Advancing Pharmacoequity in Low- and Middle-Income Countries via Model Informed Drug Development.Clinical and translational science · 2026Article
- 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 · 2026Article
Corrections and comments
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Authors and funding
2 authors.
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No grant is acknowledged in the PubMed record.
Abstract
Background: To improve the access to and affordability of medicines, countries in the Southern African Development Community (SADC) established ZaZiBoNa, a medicine regulatory harmonisation initiative. Studies have evaluated the initiative's technical and operational efficiencies and effectiveness. This study evaluated ZaZiBoNa from project implementation and cost perspectives, at the 5-year mark, to establish a business case for further investment. Methods: A quantitative and desk review were undertaken. Two surveys, one with 7 National Regulatory Authorities (NRAs) that participated in the initiative in the initial 5 years were conducted and the other with 40 pharmaceutical companies who submitted applications in the same period were recruited to share their perceived experiences and expectations with the collaborative initiative. Results: All 7 NRAs agreed the initiative had generally achieved its objectives and participation was beneficiary. As of June 2022, the 7 NRAs had registered 152 of the 235 (64.7%) products assessed during the study period, with a median time from joint assessment recommendations to registration of 7 months, against a target of 3 months (range: 4 to 14 months). Of the industry respondents ( Conclusion: The study also highlighted that implementation of initiatives could take time and that some goals can only be achieved in the medium to long term. This is a lesson for other collaboration initiatives in Africa, such as the African Medicines Agency.
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Registered trials
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