Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells
Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing preservation, storage and distribution of human tissues and cells
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
Regulation (EC) No 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004
Directive 2001/20/EC of the European Parliament and Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
COMMISSION DIRECTIVE 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products
Council Directive 98/81/EC amending Directive 20/219/EEC on the contained use of genetically modified micro-organisms
Council Directive 93/42/EEC of 14 June 1993 concerning Medical Devices
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of Member States relating to Active Implantable Medical Devices
Procedural advice on the of scientific recommendation on classification of advanced therapy medicinal products in accordance with article 17 of Regulation (EC) No 1394/2007 EMA/CAT/99623/2009
Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data
Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC
Commission Regulation (EC) No 668/2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by micro, small and medium-sized enterprises
Procedural advice on the certification of quality and non-clinical data for small and medium sized enterprises developing advanced medicinal products. EMA/CAT/418458/2008
EudraLex—Volume 10 Clinical trials guidelines. “The rules governing medicinal products in the European Union”
Detailed guidelines on good clinical practice specific to advanced therapy medicinal products. European Commission ENTR/F/2/dn (2009) 35810
Guideline on Human Cell-based Medicinal Products, EMEA/CHMP/410869/2006
EudraLex—Volume 4. EU Guidelines on Good Manufacturing Practice
Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use
Directive 2003/63/EC amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2012 2013
About this chapter
Cite this chapter
Migliaccio, G., Pintus, C. (2012). Role of the EU Framework in Regulation of Stem Cell-Based Products. In: Weyand, B., Dominici, M., Hass, R., Jacobs, R., Kasper, C. (eds) Mesenchymal Stem Cells - Basics and Clinical Application II. Advances in Biochemical Engineering/Biotechnology, vol 130. Springer, Berlin, Heidelberg. https://doi.org/10.1007/10_2012_142
Download citation
DOI: https://doi.org/10.1007/10_2012_142
Published:
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-642-37943-7
Online ISBN: 978-3-642-37944-4
eBook Packages: Chemistry and Materials ScienceChemistry and Material Science (R0)