{Reference Type}: Journal Article
{Title}: EMA commentary on the guideline on quality, nonclinical and clinical aspects of medicinal products containing genetically modified cells.
{Author}: Celis P;Farinelli G;Hidalgo-Simon A;Meij P;Tihaya M;Schüssler-Lenz M;Timón M;
{Journal}: Br J Clin Pharmacol
{Volume}: 90
{Issue}: 5
{Year}: 2024 May 2
{Factor}: 3.716
{DOI}: 10.1111/bcp.16047
{Abstract}: 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.