Global Regulatory Differences for Gene‐ and Cell‐Based Therapies: Consequences and Implications for Patient Access and Therapeutic Innovation

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 jurisdic...

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Bibliographic Details
Published in:Clinical pharmacology and therapeutics 2018-01, Vol.103 (1), p.120-127
Main Authors: Coppens, Delphi G.M., Bruin, Marie L., Leufkens, Hubert G.M., Hoekman, Jarno
Format: Article
Language:English
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Summary: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.
ISSN:0009-9236
1532-6535
DOI:10.1002/cpt.894