Regenerative medicine: A snapshot of the current regulatory environment and standards

Advanced Materials

Volumn 23, Issue 12, 2011, Pages

  Messenger, Michael P ^a   Tomlins, Paul E ^b  

^a ST JAMES S UNIVERSITY HOSPITAL   (United Kingdom)

^b NATIONAL PHYSICAL LABORATORY   (United Kingdom)

Author keywords

regenerative medicine; regulation; standards

Indexed keywords

CLINICAL USE; GENERATION TECHNOLOGIES; INDUSTRY STANDARDS; PARALLEL DEVELOPMENT; PRODUCT CONSISTENCY; REGENERATIVE MEDICINE; REGULATION; REGULATORY ENVIRONMENT; SAFETY REQUIREMENTS; TESTING PROCEDURE;

STANDARDIZATION;

ANIMAL; ARTICLE; ECONOMICS; GOVERNMENT REGULATION; HUMAN; LEGAL ASPECT; REGENERATIVE MEDICINE; STANDARD;

ANIMALS; GOVERNMENT REGULATION; HUMANS; REGENERATIVE MEDICINE;

EID: 79953058089     PISSN: 09359648     EISSN: 15214095     Source Type: Journal    
DOI: 10.1002/adma.201100254     Document Type: Article

References (33)

1. C. Mason, P. Dunnill, Regen. Med. 2008, 3, 1.
2. B. Roehr, Br. Med. J. 2010, 340, c772.
3. http://www.regener8.ac.uk/home.html, (accessed March, 2010).
4. C. Mason, Regen. Med. 2007, 2, 11.
5. D. A Cooksey, A Review of UK Health Research Funding, Her Majesty's Stationery Office, London 2006.
6. E. A. Rayment, D. J. Williams, Stem Cells 2010, 28, 996.
7. E. Hunziker, M. Spector, J. Libera, A. Gertzman, S. L. Woo, A. Ratcliffe, M. Lysaght, A. Coury, D. Kaplan, G. Vunjak-Novakovic, Tissue Eng. 2006, 12, 3341.
8. A. C. Plagnol, E. Rowley, P. Martin, F. Livesey,., Regen Med. 2009, 4, 549.
9. E. Rowley, P. Martin, Barriers to the Commercialisation and Utilisation of Regenerative Medicine in the UK, University of Nottingham 2009. (Report, previously available online at)
10. F. Livesey, A. Zimmermann, L. Dodin, M. Gregory,. Enabling the Emergence of the Regenerative Medicine Industry in the UK, University of Cambridge 2008;, (accessed February, 2011).
11. D. J. Williams, I. M. Sebastine, IEE Proc.: Nanobiotechnol. 2005, 152, 207.
12. H. Zucker, 2020: A new Vision-A Future for Regenerative Medicine, US Department of Health and Human Services, Washington DC 2006.
13. http://www.fda.gov/downloads/BiologicsBloodVaccines/Guidance- ComplianceRegulatoryInformation/Guidances/Tissue/UCM062601.pdf, (accessed February, 2011).
14. http://www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatoryInformation/default.htm, (accessed February, 2011).
15. http://www.ema.europa.eu, (accessed February, 2011).
16. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm, (accessed February, 2011).
17. http://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ ucm109108.htm, (accessed February, 2011).
18. http://www.fda.gov/BiologicsBloodVaccines/TissueTissueProducts/ RegulationofTissues/ucm150485.htm, (accessed February, 2011).
19. http://www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/ ucm072987.htm, (accessed February, 2011).
20. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/How- DrugsareDevelopedandApproved/default.htm, (accessed February, 2011).
21. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/default.htm, (accessed February, 2011).
22. C. Witten, A. Batra, C. N. Durfor, S. L. Hilbert, D. S. Kaplan, D. Fink, D. Lavoie, E. Maher, R. McFarland, in Principles of Regenerative Medicine, Academic Press, San Diego 2008, p. 1366.
23. http://ec.europa.eu/health/documents/eudralex/vol-1/index-en.htm, (accessed February, 2011).
24. http://www.ema.europa.eu/htms/human/raguidelines/advanced-therapies.htm, (accessed February, 2011).
25. http://www.iso.org/, (accessed February, 2011).
26. http://www.astm.org/, (accessed February, 2011).
27. http://shop.bsigroup.com/en/Browse-By-Subject/Regenerative-Medicine, (accessed February, 2011).
28. http://www.clsi.org/, (accessed February, 2011).
29. http://www.emrponline.eu/, (accessed February, 2011).
30. http://www.alliancerm.org/about-arm.pdf, (accessed February, 2011).
31. https://ktn.innovateuk.org/, (accessed February, 2011).
32. https://ktn.innovateuk.org/web/nanomite/, (accessed February, 2011).
33. http://www.bsigroup.com/, (accessed February, 2011).