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BJCP-EMA commentaries on the guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells.
  • +4
  • Patrick Celis,
  • GIADA FARINELLI,
  • Ana Hidalgo-Simon,
  • Pauline Meij,
  • Mara Tihaya,
  • Martina Schuessler-Lenz,
  • Marcos Timon
Patrick Celis
European Medicines Agency

Corresponding Author:[email protected]

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GIADA FARINELLI
European Medicines Agency
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Ana Hidalgo-Simon
Leiden University Medical Center
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Pauline Meij
Leiden University Medical Center
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Mara Tihaya
Leiden University Medical Center
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Martina Schuessler-Lenz
Paul-Ehrlich-Institut
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Marcos Timon
Agencia Espanola de Medicamentos y Productos Sanitarios
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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.
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