CAT - The new committee for advanced therapies at the European Medicines Agency

Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz

Volumn 53, Issue 1, 2010, Pages 9-13

  Celis, P ^a  

^a EUROPEAN MEDICINES AGENCY   (United Kingdom)

Author keywords

Advanced therapies; CAT; Cell therapy; Gene therapy; Product authorisation; Product review; Tissue engineered product

Indexed keywords

ADVISORY COMMITTEE; ARTICLE; CELL TRANSPLANTATION; CERTIFICATION; CLINICAL TRIAL; EUROPE; FINANCIAL MANAGEMENT; GENE THERAPY; HEALTH CARE QUALITY; HUMAN; LEGAL ASPECT; SAFETY; TISSUE ENGINEERING;

ADVISORY COMMITTEES; CELL TRANSPLANTATION; CERTIFICATION; CLINICAL TRIALS AS TOPIC; CONSUMER PRODUCT SAFETY; EUROPE; GENE THERAPY; HUMANS; MARKETING OF HEALTH SERVICES; QUALITY ASSURANCE, HEALTH CARE; TISSUE ENGINEERING;

EID: 77249084198     PISSN: 14369990     EISSN: 14371588     Source Type: Journal    
DOI: 10.1007/s00103-009-0998-y     Document Type: Article

References (11)

1. European 2007 Official Journal of the European Union L324 121
2. European 2001 Official Journal of the European Union L311 67
3. European 2003 Official Journal of the European Union L159 46
4. Bock A-K, 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
5. Commission of the European Communities (2005) Proposal for a Regulation 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. Impact assessment, COM (2005) 567 final, pp 1-68
6. Bock A-K, Ibarreta D, Rodriguez-Cerezo E (2003) Human tissue engineered products - Today's markets and future prospects. Synthesis report Eur 21000 EN, Institute for Prospective Technology Studies, Seville Spain, pp 1-49
7. Sanzenbacher 2007 Nat Biotechnol 25 1089 10.1038/nbt1007-1089 1:CAS:528:DC%2BD2sXhtFagt7vE 17921987 (Pubitemid 47538102)
8. European Medicines Agency (2009) Procedural advice on the evaluation of advanced therapy medicinal products in accordance with article 8 of Regulation (EC) No 1394/2007. (EMEA/630043/2008). http://www.emea.europa.eu/htms/human/ raguidelines/advanced-therapies.htm
9. European Medicines Agency (2009) 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. (EMEA/99623/2008). http://www.emea.europa.eu/htms/human/raguidelines/advanced- therapies.htm
10. European 2009 Official Journal of the European Union L194 7
11. European Medicines Agency. Medicines and emerging science - Innovation Task Force. http://www.emea.europa.eu/htms/human/mes/itf.htm