European Medicines Agency. EMA’S GUIDE ON ADVANCED THERAPY MEDICINAL PRODUCTS. Non-Clinical Development Checklist. Version 1.0 – 29 November 2021

Published by EMA

Gene Therapy Medical Products Non-Clinical Development Checklist

EMA’s guide to help developers of gene therapy medicinal products (GTMPs) and cell-based medicinal products (CBMPs) navigate the most important regulatory requirements during the non-clinical development phase

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European Medicines Agency. EMA’S GUIDE ON ADVANCED THERAPY MEDICINAL PRODUCTS. Non-Clinical Development Flowchart. Version 1.0 – 29 November 2021

Published by EMA

Gene Therapy Medical Products Non-Clinical Development Scheme

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Biologicals: Finished product

Published by EMA

Biologicals Comparability and biosimilars Gene Therapy Genetically Modified Organism Investigational Medicinal Product Lifecycle Management Pharmaceutical Development Plasma derived medicinal products Product Information

The European Medicines Agency’s scientific guidelines on biological medicinal products help medicine developers prepare marketing authorisation applications for human medicines.

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Guideline On Development And Manufacture Of Lentiviral Vectors

Published by EMA

Advanced Therapy ATMP Early Access Support Gene Therapy Lentiviral Vector Regulatory Affairs

This guideline describes quality aspects that are relevant for lentiviral vectors (LV). It applies to LV intended for ex vivo or in vivo application.

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

Published by EMA

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

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.

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Quality, preclinical and clinical aspects of Gene Therapy medicinal products

Published by EMA

Advanced Therapy Cell Therapy clinical Gene Therapy Genetically Modified Cell Non-Clinical Quality somatic cell

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.

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Genetherapy.net

Published by GeneTherapy.net

Advanced Therapy Cell Therapy Drug Discovery EMA Gene Editing Tool Gene Therapy Non-Viral Vector Regulation Affairs Research and Drug Development

Web resource for basic and clinical research in Gene Therapy, cell therapy, and genetic vaccines. In addition, it provides an overview of the different international regulations and guidelines associated with clinical Gene Therapy trials.

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The Innovation Management Toolbox was originally developed through funding from the EJP RD project, which received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 825575. The continued development and maintenance of the Toolbox are now supported by the ERDERA partnership, funded under the European Union’s Horizon Europe Research & Innovation programme, grant agreement No. 101156595.

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