Sie befinden Sich nicht im Netzwerk der Universität Paderborn. Der Zugriff auf elektronische Ressourcen ist gegebenenfalls nur via VPN oder Shibboleth (DFN-AAI) möglich. mehr Informationen...
EMA commentary on the guideline on quality, nonclinical and clinical aspects of medicinal products containing genetically modified cells
Ist Teil von
British journal of clinical pharmacology, 2024-05, Vol.90 (5), p.1203-1212
Ort / Verlag
England
Erscheinungsjahr
2024
Link zum Volltext
Quelle
Wiley Blackwell Single Titles
Beschreibungen/Notizen
Great advances have been made in the knowledge of development and regulatory approval of medicinal product containing genetically modified cells. Although a guideline has been available in the EU since 2012, the current updated version provides a useful guide to developers and professionals involved in the regulatory process of these medicines. This article presents the main issues communicated in that guidance, the regulators' insights and a commentary from the academic developers' point of view.