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EMA commentary on the guideline on quality, nonclinical and clinical aspects of medicinal products containing genetically modified cells

2 Apr 2024

Abstract excerpt

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,...

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PMID: 38565322
DOI: 10.1111/bcp.16047

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