ATMP in practice: Towards a new industry landscape in tissue engineering

Journal of Commercial Biotechnology

Volumn 15, Issue 1, 2009, Pages 59-65

  Brévignon Dodin, Laure ^a   Singh, Pawanbir ^b  

^a UNIVERSITY OF CAMBRIDGE   (United Kingdom)

^b LOUGHBOROUGH UNIVERSITY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ELECTRIC ENERGY STORAGE; LAWS AND LEGISLATION; PLANNING; STRATEGIC PLANNING;

DO-MAINS; HEALTH PROTECTIONS; MARKET ACCESSES; MARKET FRAGMENTATIONS; MEDICINAL PRODUCTS; MEDIUM SIZED ENTERPRISES; MEMBER STATES; NEW INDUSTRIES; REGENERATIVE MEDICINES; REGULATORY REGIMES; REGULATORY STRATEGIES; SIGNIFICANT IMPACTS; TECHNICAL DEVELOPMENTS; TECHNICAL GUIDELINES; TISSUE ENGINEERING INDUSTRIES; WORK IN PROGRESSES;

TISSUE ENGINEERING;

ARTICLE; CLINICAL RESEARCH; EUROPEAN UNION; FOLLOW UP; HEALTH CARE; LEGAL ASPECT; MARKETING; PHARMACY; PRACTICE GUIDELINE; PUBLIC HEALTH; REGENERATIVE MEDICINE; SAFETY; STANDARDIZATION; TISSUE ENGINEERING;

EID: 58149089680     PISSN: 14628732     EISSN: None     Source Type: Journal    
DOI: 10.1057/jcb.2008.32     Document Type: Article

References (9)

1. Williams, D. (2007). A European regulatory pathway for tissue engineering - at last. Med. Device Technol. 18(5), 8.
2. Brevignon Dodin, L. and Livesey, F. (2006). Regulation of tissue engineered products in the European union: Where are we heading? Regenerative Med. 1(5), 709-714.
3. Sanzenbacher, R., Dwenger, A., Schuessler-Lenz, M., Cichutek, K. and Flory, E. (2007). European regulation tackles tissue engineering. Nat. Biotechnol. 25(10), 1089-1091.
4. Kent, J., Faulkner, A., Geesink, I. and Fitzpatrick, D. (2006). Towards governance of human tissue engineered technologies in Europe: Framing the case for a new regulatory regime. Technol. Forecast. Soc. Changes 73, 41-60.
5. Enterprise Directorate-General (2002). Consultation Document on the Need for a Legislative Framework for Human Tissue Engineering and Tissue Engineered Products, EU Commission, Brussels.
6. Dupraz-Poiseau, A., Le Goualher, E. and Mudge, S. (2006). Insights into the new proposed EU regulation on advanced therapy medicinal products. Regul. Rapporteur 3(3), 2-4.
7. Pickering, G. (2007). The new advanced therapies regulation: Levelling the playing field for innovation, http://www.euralex.co.uk (accessed 23rd January, 2008).
8. Hughes-Wilson, W. & Mackay, D. (2007). European approval system for advanced therapies: Good news for patients and innovators alike. Regenerative Med. 2(1), 5-6.
9. This is not the intent of the regulation.