The advanced therapy classification procedure: Overview of experience gained so far1;Das Klassifizierungsverfahren neuartiger Therapien: Übersicht über bisherige Erfahrungen

Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz

Volumn 54, Issue 7, 2011, Pages 811-815

  Voltz Girolt, C ^a   Celis, P ^a   Boucaumont, M ^a   D'Apote, L ^a   Pinheiro, M H ^a   Papaluca Amati, M ^a  

^a EUROPEAN MEDICINES AGENCY   (United Kingdom)

Author keywords

Cell therapy; Classification procedure; Committee for advanced therapies; Gene therapy; Tissue engineered product

Indexed keywords

EID: 80051768531     PISSN: 14369990     EISSN: 14371588     Source Type: Journal    
DOI: 10.1007/s00103-011-1309-y     Document Type: Article

References (7)

1. European Union (2003) Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code related to medicinal products for human use. Official Journal of the European Union L159:46-94
2. Bock AK, Rodriguez-Cerezo E, Hüsing B et al (2005) Human tissue-engineered products: Potential socio-economic impacts of a new European regulatory framework for authorisation, supervision and vigilance. Synthesis report Eur 21838 EN, Institute for Prospective Technology Studies, Seville, Spain, pp 1-58
3. European Union (2007) Regulation (EC) No 1394/2007 of the European Parliament and Council of 13 November 2007 on Advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004. Official Journal of the European Union, L324:121-137
4. Procedural advice on the provision of scientific recommendation on classification of advanced therapy medicinal products in accordance with article 17 of regulation (EC) No 1394/2007
5. 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
6. Council Directive 93/42/EEC of June 1993 concerning medical devices. Official Journal of the European Union, L169, 12.7.1193
7. Council Directive 90/385/EEC of 20 June 1190 on the approximation of the laws of the Member States relating to active implantable medical devices. Official Journal of the European Union, L189, 20/.7.1190