Efficient regulatory processes are essential to ensuring that safe, effective, and affordable medicines reach patients without unnecessary delays. In South Africa, the South African Health Products Regulatory Authority (SAHPRA) plays a central role in the evaluation and approval of medicines, including generics and biosimilars. Historically, regulatory bottlenecks have posed challenges to medicine access. However, recent reforms and ongoing initiatives reflect SAHPRA’s commitment to improving regulatory efficiency while maintaining rigorous standards for safety and efficacy.
For many years, the medicine approval process in South Africa faced significant backlogs. When SAHPRA was established in 2018 to replace the Medicines Control Council (MCC), it inherited a legacy of over 16,000 outstanding applications, including both new registration applications and variation applications, including thousands for generic medicines and a growing number of biosimilar dossiers [1]. These delays had downstream effects on market entry, pricing competition, and patient access, particularly in the public sector, where procurement timelines are closely linked to product registration.
Recognising the urgency of clearing the backlog, SAHPRA launched the Backlog Clearance Project, a dedicated multi-year initiative to accelerate the review of pending applications. Through this initiative, SAHPRA has implemented risk-based evaluation approaches, engaged external reviewers, and prioritised applications for essential medicines. As of 2024, substantial progress has been made in reducing the historical backlog, and SAHPRA has reported significant improvements in median approval times for both generics and biosimilars [2].
To further streamline approvals, SAHPRA has adopted elements of reliance models, allowing it to base decisions on assessments already conducted by trusted international regulatory authorities, such as the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), and World Health Organization (WHO) prequalification programme. These models are particularly valuable for biosimilars, where extensive comparative clinical data may already exist in global markets [3]. By leveraging these assessments, SAHPRA can reduce duplication and accelerate access without compromising quality standards.
Generics benefit from abbreviated regulatory pathways focused on demonstrating bioequivalence to originator drugs. In South Africa, these submissions are guided by local and international standards, including ICH guidelines. SAHPRA continues to refine its generic application review process, including e-submission platforms, dossier tracking, and applicant guidance documents designed to improve submission quality and regulatory predictability [4].
Biosimilars, on the other hand, follow a distinct regulatory pathway that accounts for their biological complexity. In 2014, SAHPRA introduced its first guideline on biosimilars, outlining the evidence requirements for demonstrating similarity, including analytical, non-clinical, and clinical data. The guideline was updated in 2025 to align with evolving international best practices and to provide clarity on interchangeability, labelling, and post-marketing surveillance expectations [5]. These reforms have helped to create a more structured and transparent approval environment for biosimilars in South Africa.
Despite this progress, several challenges remain. Regulatory capacity, both in terms of human resources and technical infrastructure, continues to influence review timelines. Efforts are ongoing to build internal capacity through training, stakeholder engagement, and partnerships with peer regulators and academic institutions [6].
SAHPRA has also introduced digital tools to enhance workflow efficiency. Platforms such as the Electronic Common Technical Document (eCTD) are being adopted to streamline submission and review processes. These tools reduce paper-based inefficiencies, allow for better tracking of application progress, and enable faster communication between regulators and applicants [7].
Going forward, regulatory agility will be key to keeping pace with the growing number of generic and biosimilar applications, particularly as South Africa seeks to improve medicine access under initiatives like the National Health Insurance (NHI). Continued adoption of reliance strategies, risk-based assessments, and digital infrastructure will be essential to supporting both public health goals and the growth of the local pharmaceutical sector.
By enhancing the speed and reliability of its regulatory framework, SAHPRA is helping to unlock greater access to cost-effective medicines across the healthcare system. Efficient approvals for generics and biosimilars not only support pricing competition but also contribute directly to health system resilience and equity.
References
[1] SAHPRA. Backlog Clearance Project Overview and Progress Update. https://www.sahpra.org.za
[2] South African Department of Health. Annual Pharmaceutical Regulatory Performance Report (2024).
[3] WHO. Good Reliance Practices in Regulatory Decision-Making. https://www.who.int
[4] SAHPRA. Generic Medicines Guideline: Bioequivalence and Quality Standards. https://www.sahpra.org.za
[5] SAHPRA. Biosimilar Medicines: Regulatory Framework Update (2025).
[6] SAHPRA. Capacity Development Strategy and Training Partnerships (2023).
[7] SAHPRA. eCTD Implementation and Stakeholder Training Materials. https://www.sahpra.org.za