EMA commentary on the guideline on quality, nonclinical and clinical aspects of medicinal products containing genetically modified cells-Reference-Cited by-同舟云学术

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

Published:2024-04-02 Issue:5 Volume:90 Page:1203-1212
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Brit J Clinical Pharma

Author:

Celis Patrick¹,Farinelli Giada¹^ORCID,Hidalgo‐Simon Ana²,Meij Pauline²,Tihaya Mara²,Schüssler‐Lenz Martina³,Timón Marcos⁴

Affiliation:

1. European Medicines Agency Amsterdam The Netherlands

2. The Novo Nordisk Foundation Center for Stem Cell Medicine (reNEW), Leiden University Medical Center Leiden The Netherlands

3. Paul‐Ehrlich Institute Langen Germany

4. Spanish Agency of Medicines and Medical Devices Madrid Spain

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.

Funder

Novo Nordisk Fonden

Publisher

Wiley

Link

https://bpspubs.onlinelibrary.wiley.com/doi/pdf/10.1111/bcp.16047

Reference32 articles.

1. European Medicines Agency.Guideline on quality non‐clinical and clinical aspects of medicinal products containing genetically modified cells—Revision 1. (2020).https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-non-clinical-and-clinical-aspects-medicinal-products-containing-genetically-modified-cells-revision-1_en.pdf

2. European Medicines Agency.Advanced Therapies Medicinal Products.https://www.ema.europa.eu/en/human-regulatory-overview/advanced-therapy-medicinal-products-overview

3. European Commission.Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004. (2019).https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex:32007R1394

4. Gene Therapy

5. Gene therapy returns to centre stage