%0 Journal Article
%T EMA commentary on the guideline on quality, nonclinical and clinical aspects of medicinal products containing genetically modified cells.
%A Celis P
%A Farinelli G
%A Hidalgo-Simon A
%A Meij P
%A Tihaya M
%A Schüssler-Lenz M
%A Timón M
%J Br J Clin Pharmacol
%V 90
%N 5
%D 2024 May 2
%M 38565322
%F 3.716
%R 10.1111/bcp.16047
%X 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.