Article

BJCP-EMA commentaries on the guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells.

2024-03-31

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, t...

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Literature Corpus work: f1081990-b6d8-5d7c-99ec-de19072fa360
DOI: 10.22541/au.171187383.35767345/v1

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