Chapter 16. The Development of the Regulatory Process in Europe for Biological Medicines: How it Affects Gene Therapy Products
- Anthony Meager
Published Online: 10 DEC 2001
DOI: 10.1002/0470842385.ch16
Copyright © 1999 John Wiley & Sons, Ltd
Book Title
Gene Therapy Technologies, Applications and Regulations: From Laboratory to Clinic
Additional Information
How to Cite
Meager, A., Vocke, T. and Zimmermann, G. (2001) The Development of the Regulatory Process in Europe for Biological Medicines: How it Affects Gene Therapy Products, in Gene Therapy Technologies, Applications and Regulations: From Laboratory to Clinic (ed A. Meager), John Wiley & Sons, Ltd, Chichester, UK. doi: 10.1002/0470842385.ch16
Editor Information
Division of Immunobiology, The National Institute for Biological Standards and Control, South Mimms, UK
Publication History
- Published Online: 10 DEC 2001
- Published Print: 17 SEP 1999
ISBN Information
Print ISBN: 9780471967095
Online ISBN: 9780470842386
- Summary
- Chapter
Keywords:
- quality assurance;
- safety;
- guidelines;
- European Medicines Evaluation Agency;
- national regulations;
- clinical trials;
- manufacturing;
- biological potency;
- purity
Summary
Modern concepts of quality assurance and safety of biological medicines originated in the 19th century with the beginnings of antisera production. Today such medicines include vaccines, growth factors and cytokines. Medicinal agents that contain genetic materials are classified as nucleic acids, vectors and cellular vehicles. Despite the wide spectrum of materials used for their preparation, gene therapy products are generally considered together when deciding quality assurance and safety criteria. The European Medicines Evaluation Agency formulates specific guidelines on data requirements for conventional biologics and biotechnology medicines within the European Union. Gene therapy products in early stages of evaluation are subject to national regulations in the member states where clinical trials are being conducted. Special considerations are required for the production of viral vectors, packaging cell lines and genetically modified somatic cells. Quality assurance and safety issues are paramount during manufacturing, while purity and biological potency are regulated by international guidelines.