European Medicines Agency. Committee for Advanced Therapies (CAT). Guideline on Quality, Non-Clinical and Clinical Aspects of Medicinal Products Containing Genetically Modified Cells. 3 November 2020. EMA/CAT/GTWP/671639/2008 Rev. 1

Published by EMA

Non-Clinical Guideline Quality Clinical Aspects Genetically Modified Cell

Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells

View this resource Bookmark this resource

Quality, preclinical and clinical aspects of Gene Therapy medicinal products

Published by EMA

Regulatory Affairs Advanced Therapy Gene Therapy Quality Guideline ATMP Non-Clinical

Guide for the development and evaluation of Gene Therapy Medicinal Products (GTMPs) intended for use in humans and presented for Marketing Authorisation Application (MAA). Its focus is on the quality, Safety and efficacy requirements of GTMPs.

View this resource Bookmark this resource

Guideline On The Non-Clinical Studies Required Before First Clinical Use Of Gene Therapy Medicinal Products

Published by EMA

Early Access Support Regulatory Affairs First Clinical Use Non-Clinical Gene Therapy Advanced Therapy

This document defines scientific principles and provides guidance to applicants developing Gene Therapy medicinal products (GTMPs). It focuses on the non-clinical studies required before the first use of a GTMPs in human subjects.

View this resource Bookmark this resource

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience. See our Cookie Policy

Necessary

Always Enabled

Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.

Cookie	Duration	Description
Bookmark Cookie	12 months	This cookie saves your bookmarked resources to your local browser for future use.
Cookie Policy	11 months	The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.

Analytics

IMT Feedback

Did the IMT help you in finding the resource you needed?