Portal de Periódicos da CAPES

Regenerative Medicine: A Snapshot of the Current Regulatory Environment and Standards

2011; Volume: 23; Issue: 12 Linguagem: Inglês

10.1002/adma.201100254

1521-4095

Michael Messenger, P E Tomlins,

Pluripotent Stem Cells Research

Advanced MaterialsVolume 23, Issue 12 p. H10-H17 Essay “Advanced Healthcare Materials” Regenerative Medicine: A Snapshot of the Current Regulatory Environment and Standards Michael P. Messenger, Corresponding Author Michael P. Messenger [email protected] Clinical and Biomedical Proteomics Group, Cancer Research UK Centre, Leeds Institute of Molecular Medicine, St James’s University Hospital, Beckett Street, Leeds, LS9 7TF, UK Michael P. Messenger, Clinical and Biomedical Proteomics Group, Cancer Research UK Centre, Leeds Institute of Molecular Medicine, St James’s University Hospital, Beckett Street, Leeds, LS9 7TF, UK Paul E. Tomlins, National Physical Laboratory, Hampton Road, Teddington, Middlesex, TW11 0LW, UK.Search for more papers by this authorPaul E. Tomlins, Corresponding Author Paul E. Tomlins [email protected] National Physical Laboratory, Hampton Road, Teddington, Middlesex, TW11 0LW, UK Michael P. Messenger, Clinical and Biomedical Proteomics Group, Cancer Research UK Centre, Leeds Institute of Molecular Medicine, St James’s University Hospital, Beckett Street, Leeds, LS9 7TF, UK Paul E. Tomlins, National Physical Laboratory, Hampton Road, Teddington, Middlesex, TW11 0LW, UK.Search for more papers by this author Michael P. Messenger, Corresponding Author Michael P. Messenger [email protected] Clinical and Biomedical Proteomics Group, Cancer Research UK Centre, Leeds Institute of Molecular Medicine, St James’s University Hospital, Beckett Street, Leeds, LS9 7TF, UK Michael P. Messenger, Clinical and Biomedical Proteomics Group, Cancer Research UK Centre, Leeds Institute of Molecular Medicine, St James’s University Hospital, Beckett Street, Leeds, LS9 7TF, UK Paul E. Tomlins, National Physical Laboratory, Hampton Road, Teddington, Middlesex, TW11 0LW, UK.Search for more papers by this authorPaul E. Tomlins, Corresponding Author Paul E. Tomlins [email protected] National Physical Laboratory, Hampton Road, Teddington, Middlesex, TW11 0LW, UK Michael P. Messenger, Clinical and Biomedical Proteomics Group, Cancer Research UK Centre, Leeds Institute of Molecular Medicine, St James’s University Hospital, Beckett Street, Leeds, LS9 7TF, UK Paul E. Tomlins, National Physical Laboratory, Hampton Road, Teddington, Middlesex, TW11 0LW, UK.Search for more papers by this author First published: 23 March 2011 https://doi.org/10.1002/adma.201100254Citations: 15Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL References 1 C. Mason, P. Dunnill, Regen. Med. 2008, 3, 1. 2 B. Roehr, Br. Med. J. 2010, 340, c772. 3http://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 http://www.nottingham.ac.uk/iss/research/Current-Research-Projects/Staff_projects/regenmed/reports_publications.htm) 10 F. Livesey, A. Zimmermann, L. Dodin, M. Gregory. Enabling the Emergence of the Regenerative Medicine Industry in the UK, University of Cambridge 2008; http://www.ifm.eng.cam.ac.uk/cig/documents/Workingpaper3.pdf, (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. 13http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM062601.pdf, (accessed February, 2011). 14http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, (accessed February, 2011). 15http://www.ema.europa.eu, (accessed February, 2011). 16http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm, (accessed February, 2011). 17http://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm109108.htm, (accessed February, 2011). 18http://www.fda.gov/BiologicsBloodVaccines/TissueTissueProducts/RegulationofTissues/ucm150485.htm, (accessed February, 2011). 19http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/ucm072987.htm, (accessed February, 2011). 20http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/default.htm, (accessed February, 2011). 21http://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. 23http://ec.europa.eu/health/documents/eudralex/vol-1/index_en.htm, (accessed February, 2011). 24http://www.ema.europa.eu/htms/human/raguidelines/advanced_therapies.htm, (accessed February, 2011). 25http://www.iso.org/, (accessed February, 2011). 26http://www.astm.org/, (accessed February, 2011). 27http://shop.bsigroup.com/en/Browse-By-Subject/Regenerative-Medicine, (accessed February, 2011). 28http://www.clsi.org/, (accessed February, 2011). 29http://www.emrponline.eu/, (accessed February, 2011). 30http://www.alliancerm.org/about_arm.pdf, (accessed February, 2011). 31https://ktn.innovateuk.org/, (accessed February, 2011). 32https://ktn.innovateuk.org/web/nanomite/, (accessed February, 2011). 33http://www.bsigroup.com/, (accessed February, 2011). Citing Literature Volume23, Issue12March 25, 2011Pages H10-H17 ReferencesRelatedInformation