학술논문
EMA commentary on the guideline on quality, nonclinical and clinical aspects of medicinal products containing genetically modified cells.
Document Type
Article
Author
Source
Subject
*REGULATORY approval
*GENE therapy
*
Language
ISSN
0306-5251
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. [ABSTRACT FROM AUTHOR]