ZAZIBONA, named from Zambia, Zimbabwe, Botswana, and Namibia, is a collaborative medicines registration initiative linked to the SADC medicines regulatory harmonisation agenda. Established in 2013, it enables participating countries to jointly assess medicine applications, share evaluation work, and reduce duplication of regulatory review processes across the region. Over time, the initiative expanded beyond its founding members and now includes most SADC regulatory authorities, including South Africa’s SAHPRA.
In 2025, regional work-sharing initiatives such as ZAZIBONA are being used more deliberately as capacity-support tools as regulators manage higher volumes and increasing product complexity. As regulatory authorities across Africa face increasing application volumes, limited technical capacity, and rising product complexity, work-sharing mechanisms have shifted from being optional collaborations to structural tools for efficiency. Within the SADC region, ZAZIBONA has demonstrated practical functionality as a structured, operational work-sharing platform. For South Africa, active participation in ZAZIBONA reflects its engagement in regional regulatory networks and supports the gradual integration of shared regulatory functions across SADC, contributing to more coordinated review processes while upholding established national standards. In this context, regional harmonisation of review processes is emerging as a key enabler for regulatory alignment and mutual confidence among participating authorities.
South Africa’s regulatory landscape has undergone significant reform since the establishment of the South African Health Products Regulatory Authority (SAHPRA) in 2018. SAHPRA inherited a substantial backlog of applications from the former Medicines Control Council (MCC), reportedly exceeding 16,000 medicines regulatory applications (including new registrations and variations)[1][2]. Clearing this backlog became a central priority.
The Backlog Clearance Project, initiated in phases from 2019 onward, introduced risk-based prioritisation and reliance mechanisms to accelerate review of pending dossiers [2]. Public reports from SAHPRA indicate that thousands of historical applications have since been finalised, with measurable reductions in aged applications [3]. However, while legacy backlog reduction has progressed, the system continues to face high inflows of new submissions, particularly in generics and post-approval variations.
Current regulatory performance must therefore be assessed across two dimensions: backlog status and forward-looking review capacity. Available performance data from SAHPRA’s Annual Performance Plans indicate that review timelines vary by product category, with Review timelines vary by pathway and product type, and are influenced by factors such as dossier quality, evaluator capacity, and inspection scheduling[3]. Nevertheless, review durations remain influenced by evaluator availability, dossier completeness, and inspection scheduling.
This is where reliance frameworks, including ZAZIBONA, have increasing strategic relevance. Under ZAZIBONA, participating regulators collaborate on dossier assessment, share technical reports, and aim to harmonise evaluation outcomes. While final approval decisions remain national, shared assessments reduce duplication of technical review effort across countries [4]. By contrast, broader international reliance models have faced operational variability in implementation across jurisdictions, highlighting the importance of structured, regionally harmonised processes that are adapted to comparable regulatory environments.
For South Africa, engagement in ZAZIBONA provides several advantages:
First, it supports capacity optimisation. Technical evaluators can leverage peer assessments, reducing repetitive scientific review while maintaining sovereign decision-making. Second, it enhances regional alignment. As pharmaceutical manufacturers increasingly view Southern Africa as an integrated market, harmonised timelines reduce market fragmentation. Third, it strengthens regulatory benchmarking. Shared review processes promote consistency in quality standards across participating states. The operational experience of ZAZIBONA reinforces the value of practical harmonisation mechanisms that regulators can implement within aligned policy and legal frameworks.
Beyond ZAZIBONA, SAHPRA has signalled commitment to broader reliance approaches, including use of assessments from trusted reference authorities and participation in WHO Collaborative Registration Procedures [5]. Globally, reliance models are recognised by the World Health Organization as a best-practice tool for strengthening regulatory efficiency without compromising quality [6]. However, implementation experiences internationally have shown that reliance effectiveness depends heavily on regulatory maturity alignment, procedural compatibility, and legal flexibility across participating authorities.
However, reliance is not synonymous with automatic approval. Even where external scientific reports are used, contextual requirements, such as local labelling, pharmacovigilance readiness, and manufacturing compliance, remain subject to national verification. For applicants, this means dossier quality, completeness, and alignment with regional guidance remain critical.
In parallel, regulatory expectations are evolving beyond initial approval. GMP inspection capacity, pharmacovigilance reporting, and lifecycle management have become increasingly prominent in SAHPRA’s operational focus. Post-approval variations, renewals, and safety updates represent a growing portion of regulatory workload, adding complexity to resource planning [3].
Digital transformation is another component of the 2025/26 outlook. While SAHPRA has implemented electronic submission processes, full end-to-end digitisation remains in development. Hybrid workflows continue to shape operational timelines. Industry stakeholders should anticipate gradual but continued improvements in submission tracking and query management systems over the coming year.
Looking ahead to 2026, several trends are likely to define regulatory performance:
- Continued emphasis on clearing residual legacy backlog categories
- Increased utilisation of reliance and regional work-sharing frameworks such as ZAZIBONA
- Greater scrutiny of manufacturing compliance and post-market obligations
- Progressive digital process refinement
Importantly, regulatory efficiency must be evaluated alongside regulatory strength. The global regulatory environment has shifted toward stronger oversight, enhanced pharmacovigilance, and stricter manufacturing verification. South Africa’s trajectory reflects this broader pattern.
For industry, the implication is clear: regulatory readiness in 2025/26 requires strategic alignment with evolving reliance pathways, strengthened dossier quality controls, and proactive engagement with regional harmonisation mechanisms. ZAZIBONA’s operational model illustrates how structured regional harmonisation can function as a practical regulatory tool within comparable jurisdictions.
As application volumes rise and product complexity increases, the interplay between backlog management, reliance adoption, and digital modernisation will define South Africa’s regulatory landscape in the coming year.
References
[1] Gray A, Riddin J. The Regulatory System for Medicines in South Africa: Transition to a New Era. Journal of Pharmaceutical Policy and Practice.
[2] SAHPRA. Backlog Clearance Programme Updates and Public Reports.
[3] SAHPRA. Annual Performance Plan 2023/24 and 2024/25.
[4] SADC. ZAZIBONA Collaborative Medicines Registration Initiative Overview.
[5] World Health Organization. Collaborative Registration Procedure.
[6] WHO. Good Regulatory Practices: Guidelines for National Regulatory Authorities.