EMA commentary on the guideline on quality, nonclinical and clinical aspects of medicinal products containing genetically modified cells.
- Resource Type
- Article
- Authors
- Celis, Patrick; Farinelli, Giada; Hidalgo‐Simon, Ana; Meij, Pauline; Tihaya, Mara; Schüssler‐Lenz, Martina; Timón, Marcos
- Source
- British Journal of Clinical Pharmacology. May2024, Vol. 90 Issue 5, p1203-1212. 10p.
- Subject
- *REGULATORY approval
*GENE therapy
- Language
- ISSN
- 0306-5251
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. [ABSTRACT FROM AUTHOR]