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

Authors :: Coppens DGM
De Bruin ML
Leufkens HGM
Hoekman J
Source :: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2018 Jan; Vol. 103 (1), pp. 120-127. Date of Electronic Publication: 2017 Nov 06.
Publication Year :: 2018
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.<br /> (© 2017 American Society for Clinical Pharmacology and Therapeutics.)

Subjects :: Global Health
Health Services Accessibility
Humans
Cell- and Tissue-Based Therapy methods
Drug Approval methods
Drug Approval organization & administration
Drug and Narcotic Control organization & administration
Genetic Therapy methods

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