Global Regulatory Differences for Gene- and Cell-Based Therapies: Consequences and Implications for Patient Access and Therapeutic Innovation
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Publication date
2018
Authors
Coppens, Delphi G M
de Bruin, M.L.
Leufkens, Bert
Hoekman, Jarno
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Article
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Abstract
Gene- and cell-based therapies (GCTs) offer potential new treatment options for unmet medical needs. However, the use of conventional regulatory requirements for medicinal products to approve GCTs may impede patient access and therapeutic innovation. Furthermore, requirements differ between jurisdictions, complicating the global regulatory landscape. We provide a comparative overview of regulatory requirements for GCT approval in five jurisdictions and hypothesize on the consequences of the observed global differences on patient access and therapeutic innovation.
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Taverne
Citation
Coppens, D G M, De Bruin, M L, Leufkens, H G M & Hoekman, J 2018, 'Global Regulatory Differences for Gene- and Cell-Based Therapies : Consequences and Implications for Patient Access and Therapeutic Innovation', Clinical Pharmacology and Therapeutics, vol. 103, no. 1, pp. 120-127. https://doi.org/10.1002/cpt.894