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
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 t...
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| Format: | Article |
| Language: | English |
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South African Medical Association
2025-02-01
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| Series: | South African Medical Journal |
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| Online Access: | https://samajournals.co.za/index.php/samj/article/view/2629 |
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| author | I M Viljoen M S Pepper |
| author_facet | I M Viljoen M S Pepper |
| author_sort | I M Viljoen |
| collection | DOAJ |
| description |
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.
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| format | Article |
| id | doaj-art-8021a9edd57d43bf8cc191f001d132aa |
| institution | Kabale University |
| issn | 0256-9574 2078-5135 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | South African Medical Association |
| record_format | Article |
| series | South African Medical Journal |
| spelling | doaj-art-8021a9edd57d43bf8cc191f001d132aa2025-02-10T12:25:24ZengSouth African Medical AssociationSouth African Medical Journal0256-95742078-51352025-02-01115110.7196/SAMJ.2025.v115i1.2629Addressing the limitations of the regulatory landscape in South Africa regarding advanced cell and gene therapies and related sectors involving human cells, tissues and organsI M Viljoen0https://orcid.org/0000-0002-8582-6404M S Pepper1https://orcid.org/0000-0001-6406-2380Institute for Cellular and Molecular Medicine, and SAMRC Extramural Unit for Stem Cell Research and Therapy, Faculty of Health Sciences, University of Pretoria, South AfricaInstitute for Cellular and Molecular Medicine, and SAMRC Extramural Unit for Stem Cell Research and Therapy, Faculty of Health Sciences, University of Pretoria, South Africa 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. https://samajournals.co.za/index.php/samj/article/view/2629Advanced Cell-Based ProductsGene TherapiesRegulatory FrameworksSouth AfricaMedicines and Related Substances ActNational Health Act |
| spellingShingle | I M Viljoen M S Pepper 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 South African Medical Journal Advanced Cell-Based Products Gene Therapies Regulatory Frameworks South Africa Medicines and Related Substances Act National Health Act |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Advanced Cell-Based Products Gene Therapies Regulatory Frameworks South Africa Medicines and Related Substances Act National Health Act |
| url | https://samajournals.co.za/index.php/samj/article/view/2629 |
| work_keys_str_mv | AT imviljoen addressingthelimitationsoftheregulatorylandscapeinsouthafricaregardingadvancedcellandgenetherapiesandrelatedsectorsinvolvinghumancellstissuesandorgans AT mspepper addressingthelimitationsoftheregulatorylandscapeinsouthafricaregardingadvancedcellandgenetherapiesandrelatedsectorsinvolvinghumancellstissuesandorgans |