BJCP-EMA commentaries on the guideline on quality, non-clinical and
clinical aspects of medicinal products containing genetically modified
cells.
- Patrick Celis,
- GIADA FARINELLI
, - Ana Hidalgo-Simon,
- Pauline Meij,
- Mara Tihaya,
- Martina Schuessler-Lenz,
- Marcos Timon
Patrick Celis
European Medicines Agency
Corresponding Author:patrick.celis@ema.europa.eu
Author ProfileMarcos Timon
Agencia Espanola de Medicamentos y Productos Sanitarios
Author ProfileAbstract
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.15 Feb 2024Submitted to British Journal of Clinical Pharmacology 15 Feb 2024Submission Checks Completed
15 Feb 2024Assigned to Editor
15 Feb 2024Review(s) Completed, Editorial Evaluation Pending
16 Feb 2024Editorial Decision: Accept
