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Volumn 9, Issue 10, 2007, Pages 904-909

Gene therapy legislation in The Netherlands

Author keywords

Directive 2001 18 EC; Environmental risk assessment; Gene therapy; Genetically modified organism; Regulation; The Netherlands

Indexed keywords

CLINICAL ASSESSMENT; CLINICAL EVALUATION; CLINICAL PRACTICE; CONFERENCE PAPER; CONSULTATION; DECISION MAKING; ENVIRONMENTAL IMPACT ASSESSMENT; ENVIRONMENTAL MANAGEMENT; ENVIRONMENTAL MONITORING; GENE THERAPY; HEALTH CARE POLICY; HEALTH EDUCATION; HUMAN; INFORMATION DISSEMINATION; MEDICAL ETHICS; MEDICAL RESEARCH; NETHERLANDS; ORGANIZATION; PRIORITY JOURNAL; QUALITY CONTROL; RESEARCH SUBJECT; RESPONSIBILITY; RISK ASSESSMENT; TRANSGENIC ORGANISM;

EID: 35148899301     PISSN: 1099498X     EISSN: 15212254     Source Type: Journal    
DOI: 10.1002/jgm.1095     Document Type: Conference Paper
Times cited : (4)

References (11)
  • 1
    • 9244243165 scopus 로고    scopus 로고
    • Bone marrow gene transfer in three patients with adenosine deaminase deficiency
    • Hoogerbrugge PM, van Beusechem VW, Fischer A, et al. Bone marrow gene transfer in three patients with adenosine deaminase deficiency. Gene Ther 1996; 3: 179-183.
    • (1996) Gene Ther , vol.3 , pp. 179-183
    • Hoogerbrugge, P.M.1    van Beusechem, V.W.2    Fischer, A.3
  • 2
    • 35148840877 scopus 로고    scopus 로고
    • Commission of the European Communities (2001). Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (Official Journal L 121, 1/5/2001 p. 34-44).
    • Commission of the European Communities (2001). Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (Official Journal L 121, 1/5/2001 p. 34-44).
  • 3
    • 35148900653 scopus 로고    scopus 로고
    • Commission of the European Communities (2001). Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (Official Journal L 106, 17/4/2001 p. 1-39).
    • Commission of the European Communities (2001). Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (Official Journal L 106, 17/4/2001 p. 1-39).
  • 4
    • 35148885057 scopus 로고    scopus 로고
    • Commission of the European Communities (1998). Council Directive 98/81/ EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms (Official Journal L 330, 5/12/ 1998 p. 13-31).
    • Commission of the European Communities (1998). Council Directive 98/81/ EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms (Official Journal L 330, 5/12/ 1998 p. 13-31).
  • 5
    • 0011835106 scopus 로고    scopus 로고
    • Gene therapy in Germany and in Europe: Regulatory issues
    • Cichutek K, Krämer I. Gene therapy in Germany and in Europe: regulatory issues. Qual Assur J 1997; 2: 141-152.
    • (1997) Qual Assur J , vol.2 , pp. 141-152
    • Cichutek, K.1    Krämer, I.2
  • 6
    • 0036447546 scopus 로고    scopus 로고
    • Euregenethy Network. Opinion paper on the current status of the regulation of gene therapy in Europe
    • Cohen-Haguenauer O, Rosenthal F, Gansbacher B, et al. Euregenethy Network. Opinion paper on the current status of the regulation of gene therapy in Europe. Hum Gene Ther 2002; 13: 2085-2110.
    • (2002) Hum Gene Ther , vol.13 , pp. 2085-2110
    • Cohen-Haguenauer, O.1    Rosenthal, F.2    Gansbacher, B.3
  • 7
    • 35148898058 scopus 로고    scopus 로고
    • Analysis of the applicability of the contained use legislation for clinical trials 2006; Perseus BVBA.
    • Analysis of the applicability of the contained use legislation for clinical trials 2006; Perseus BVBA.
  • 8
    • 35148899460 scopus 로고    scopus 로고
    • Commission of the European Communities (2001). Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (Official Journal L 311, 28/11/2001 p. 67-128).
    • Commission of the European Communities (2001). Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (Official Journal L 311, 28/11/2001 p. 67-128).
  • 9
    • 35148839995 scopus 로고    scopus 로고
    • Commission of the European Communities. (2004). Regulation (EC) No 726/ 2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Official Journal L 136, 30/4/2004 p. 1-33).
    • Commission of the European Communities. (2004). Regulation (EC) No 726/ 2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Official Journal L 136, 30/4/2004 p. 1-33).
  • 10
    • 0038690170 scopus 로고    scopus 로고
    • Regulatory issues in human gene therapy
    • Cornetta K. Regulatory issues in human gene therapy. Blood Cells Mol Dis 2003; 31: 51-56.
    • (2003) Blood Cells Mol Dis , vol.31 , pp. 51-56
    • Cornetta, K.1
  • 11
    • 27544459099 scopus 로고    scopus 로고
    • Gene therapy bio-safety: Scientific and regulatory issues
    • Gonin P, Buchholz CJ, Pallardy M, Mezzina M. Gene therapy bio-safety: scientific and regulatory issues. Gene Ther 2005; 12: S146-152.
    • (2005) Gene Ther , vol.12
    • Gonin, P.1    Buchholz, C.J.2    Pallardy, M.3    Mezzina, M.4


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