Abstract

VILJOEN, I M  and  PEPPER, M S. Addressing the limitations of the regulatory landscape in South Africa regarding advanced cell and gene therapies and related sectors involving human cells, tissues and organs. SAMJ, S. Afr. med. j. [online]. 2025, vol.115, n.1, pp.12-16. ISSN 2078-5135.  https://doi.org/10.7196/SAMJ.2024.v115i1.2629.

Advanced cell-based and gene therapy products emerged during the 1990s as new health product categories for treating and curing previously untreatable or incurable conditions. These products are complex, diverse and therapeutically specific, requiring specialised regulatory frameworks. During the last three decades, several jurisdictions have constructed specific regulatory frameworks to ensure these products' safety, clinical efficacy and quality. As these are new and disruptive products, these frameworks are continuously evolving. However, South Africa (SA)'s regulatory frameworks for medicines, human biological materials and genetically modified organisms have not kept pace with scientific and technological developments, leaving regulatory gaps. We briefly describe these novel products and their regulatory frameworks, and propose a way forward in SA.

Keywords : advanced cell-based products; gene therapies; regulatory frameworks; South Africa; Medicines and Related Substances Act; National Health Act.

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