Questions and answers on gene therapy

Table of contents

Keywords Gene therapy medicinal products, European Pharmacopoeia, comparability, characterisation, host cell DNA, selection marker, potency, viral shedding, GMO requirements
Description This document addresses questions on matters related to the development of gene therapy medicinal products. It provides harmonized position on issues that can be subject to different interpretation or require clarification, typically arising from discussions during briefing meetings with stakeholders.

How useful was this page?

Add your rating