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Volumn 507, Issue , 2012, Pages 337-354

Regulatory structures for gene therapy medicinal products in the European union

Author keywords

ATMP regulation; Centralized marketing authorization; Committee for advanced therapies; Dossier requirements; Incentives; Orphan medicinal products; Research network; SME office

Indexed keywords

CELL THERAPY AGENT; GENE THERAPY AGENT; NEW DRUG; NUCLEIC ACID; ORPHAN DRUG;

EID: 84857529471     PISSN: 00766879     EISSN: 15577988     Source Type: Book Series    
DOI: 10.1016/B978-0-12-386509-0.00017-X     Document Type: Chapter
Times cited : (21)

References (27)
  • 2
    • 44049106551 scopus 로고    scopus 로고
    • Potential of AAV vectors in the treatment of metabolic disease
    • DOI 10.1038/gt.2008.64, PII GT200864, Special Issue: AAV Vectors for Clinical GeneTherapy
    • I.E. Alexander Potential of AAV vectors in the treatment of metabolic disease Gene Ther. 15 2008 831 839 (Pubitemid 351712616)
    • (2008) Gene Therapy , vol.15 , Issue.11 , pp. 831-839
    • Alexander, I.E.1    Cunningham, S.C.2    Logan, G.J.3    Christodoulou, J.4
  • 4
    • 70449427834 scopus 로고    scopus 로고
    • Hematopoietic stem cell gene therapy with a lentiviral vector in X-linked adrenoleukodystrophy
    • N. Cartier Hematopoietic stem cell gene therapy with a lentiviral vector in X-linked adrenoleukodystrophy Science 326 2009 818 823
    • (2009) Science , vol.326 , pp. 818-823
    • Cartier, N.1
  • 5
    • 84857599096 scopus 로고    scopus 로고
    • CAT monthly reports published on the EMA website
    • CAT monthly reports published on the EMA website. http://www.ema.europa. eu/ema/index.jsp?curl=pages/news-and-events/document-listing/ document-listing-000196.jsp&murl=menus/about-us/about-us.jsp&mid= WC0b01ac05800292a8
  • 6
    • 77249084198 scopus 로고    scopus 로고
    • CAT - The new committee for advanced therapies at the European Medicines Agency
    • P. Celis CAT - The new committee for advanced therapies at the European Medicines Agency Bundesgesundheitsblatt 53 2010 9 13
    • (2010) Bundesgesundheitsblatt , vol.53 , pp. 9-13
    • Celis, P.1
  • 7
    • 84857525350 scopus 로고    scopus 로고
    • Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use
    • 14 October
    • Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. Official J. Eur. UnionL 262, 14 October 2003, p 24. http://ec.europa.eu/health/ files/eudralex/vol-1/dir-2003-94/dir-2003-94-en.pdf
    • (2003) Official J. Eur. UnionL , vol.262 , pp. 24
  • 8
    • 33748267129 scopus 로고    scopus 로고
    • Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises
    • 20 May
    • Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises. Official J. Eur. UnionL 124, 20 May 2003, p. 36. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri= OJ:L:2003:124:0036:0041:en:PDF
    • (2003) Official J. Eur. UnionL , vol.124 , pp. 36
  • 9
    • 29344453431 scopus 로고    scopus 로고
    • Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products
    • 9 April
    • Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products. Official J. Eur. UnionL 91, 9 April 2003, p. 13. http://ec.europa.eu/health/files/eudralex/vol-1/dir- 2005-28/dir-2005-28-en.pdf
    • (2003) Official J. Eur. UnionL , vol.91 , pp. 13
  • 10
    • 0012111484 scopus 로고    scopus 로고
    • Directive 2001/83/EC of the European Parliament and the Council of 13 November 2007 on the Community code relating to medicinal products for human use
    • 28 November Consolidated version 05/10/2009
    • Directive 2001/83/EC of the European Parliament and the Council of 13 November 2007 on the Community code relating to medicinal products for human use. Official J. Eur. UnionL 311, 28 November 2001, p. 67. Consolidated version 05/10/2009. http://ec.europa.eu/health/files/eudralex/vol-1/reg-2008-1234/reg- 2008-1234-en.pdf
    • (2001) Official J. Eur. UnionL , vol.311 , pp. 67
  • 11
    • 84857599095 scopus 로고    scopus 로고
    • EMA/CAT/235374/2010: Committee for Advanced Therapies (CAT) Work Programme 2010-2015
    • EMA/CAT/235374/2010: Committee for Advanced Therapies (CAT) Work Programme 2010-2015. http://www.ema.europa.eu/docs/en-GB/document-library/Work- programme/2010/11/WC500099029.pdf
  • 17
    • 84857608996 scopus 로고    scopus 로고
    • Innovation Task Force (ITF)
    • Innovation Task Force (ITF). http://www.ema.europa.eu/ema/index.jsp?curl= pages/regulation/general/general-content-000334.jsp&murl=menus/regulations/ regulations.jsp&mid=WC0b01ac05800ba1d9
  • 18
    • 77249171677 scopus 로고    scopus 로고
    • Legal basis of the Advanced Therapies Regulation
    • V. Jekerle Legal basis of the Advanced Therapies Regulation Bundesgesundheitsblatt 53 2010 4 8
    • (2010) Bundesgesundheitsblatt , vol.53 , pp. 4-8
    • Jekerle, V.1
  • 19
    • 77949327872 scopus 로고    scopus 로고
    • Retrovirus gene therapy for X-linked chronic granulomatous disease can achieve stable long-term correction of oxidase activity in peripheral blood neutrophils
    • E.M. Kang Retrovirus gene therapy for X-linked chronic granulomatous disease can achieve stable long-term correction of oxidase activity in peripheral blood neutrophils Blood 115 4 2010 783 791
    • (2010) Blood , vol.115 , Issue.4 , pp. 783-791
    • Kang, E.M.1
  • 21
    • 76949104143 scopus 로고    scopus 로고
    • Factors associated with success of marketing authorization applications for pharmaceutical drugs submitted to the European Medicines Agency
    • J. Regnstom Factors associated with success of marketing authorization applications for pharmaceutical drugs submitted to the European Medicines Agency Eur. J. Clin. Pharmacol. 66 1 2009 39 48
    • (2009) Eur. J. Clin. Pharmacol. , vol.66 , Issue.1 , pp. 39-48
    • Regnstom, J.1
  • 22
    • 77958499413 scopus 로고    scopus 로고
    • Regulation (EC) No. 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No. 726/2004
    • 10 December
    • Regulation (EC) No. 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No. 726/2004. Official J. Eur. UnionL 324, 10 December 2007, p. 121
    • (2007) Official J. Eur. UnionL , vol.324 , pp. 121
  • 23
    • 0003187521 scopus 로고    scopus 로고
    • Regulation (EC) No. 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products
    • 22 January
    • Regulation (EC) No. 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products. Official J. Eur. UnionL 18, 22 January 2000, p. 1. http://ec.europa.eu/health/files/eudralex/vol- 1/reg-2000-141/reg-2000-141-en.pdf
    • (2000) Official J. Eur. UnionL , vol.18 , pp. 1
  • 25
    • 77649194372 scopus 로고    scopus 로고
    • Challenges with advanced therapy medicinal products and how to meet them
    • C.K. Schneider Challenges with advanced therapy medicinal products and how to meet them Nat. Rev. Drug Discov. 9 3 2010 195 201
    • (2010) Nat. Rev. Drug Discov. , vol.9 , Issue.3 , pp. 195-201
    • Schneider, C.K.1
  • 26
    • 78649451337 scopus 로고    scopus 로고
    • The different extent of B and T cell immune reconstitution after hematopoietic stem cell transplantation and enzyme replacement therapies in SCID patients with adenosine deaminase deficiency
    • F. Serana The different extent of B and T cell immune reconstitution after hematopoietic stem cell transplantation and enzyme replacement therapies in SCID patients with adenosine deaminase deficiency J. Immunol. 185 2010 7713 7722
    • (2010) J. Immunol. , vol.185 , pp. 7713-7722
    • Serana, F.1


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