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Volumn 2003, Issue 1, 2003, Pages 3-8

EMEA and gene therapy medicinal products development in the European union

Author keywords

[No Author keywords available]

Indexed keywords

GENE PRODUCT; ORPHAN DRUG;

EID: 0037671818     PISSN: 11107243     EISSN: None     Source Type: Journal    
DOI: 10.1155/S1110724303209104     Document Type: Review
Times cited : (2)

References (14)
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    • 0004365481 scopus 로고
    • Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal-Products
    • Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal-Products. Official Journal of the European Communities. 1993;(L 214):1-21.
    • (1993) Official Journal of the European Communities , vol.L214 , pp. 1-21
  • 2
    • 0034222114 scopus 로고    scopus 로고
    • Europe and medicines: Role of the EMEA
    • Sauer F. Europe and medicines: role of the EMEA. Ann Pharm Fr. 2000;58(4):278-285.
    • (2000) Ann Pharm Fr , vol.58 , Issue.4 , pp. 278-285
    • Sauer, F.1
  • 3
    • 0032740491 scopus 로고    scopus 로고
    • The European Agency for the Evaluation of Medicinal Product's centralized approach to product approval: Current status
    • Healy EM Katin KI. The European Agency for the Evaluation of Medicinal Product's centralized approach to product approval: current status Drug In J. 1999;33(4):969-978.
    • (1999) Drug In J , vol.33 , Issue.4 , pp. 969-978
    • Healy, E.M.1    Kaitin, K.I.2
  • 4
    • 85003600742 scopus 로고    scopus 로고
    • European Agency for the Evaluation of Medicinal Products. Seventh Annual Report 2001. Available at: http://www.emea.eu.int/pdfs/general/direct/emeaar/005201en.pdf, accessed July 10, 2002.
    • Seventh Annual Report 2001
  • 5
    • 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
    • Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products. Official Journal of the European Communities. 2001;(L 18):1-5.
    • (2001) Official Journal of the European Communities , vol.L18 , pp. 1-5
  • 6
    • 0012111484 scopus 로고    scopus 로고
    • 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
    • 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 of the European Communities. 2001;(L 311):67-128.
    • (2001) Official Journal of the European Communities , vol.L311 , pp. 67-128
  • 7
    • 0037814515 scopus 로고    scopus 로고
    • Commission Directive 2000/37/EC of 5 June 2000 amending Chapter VIa "Pharmacovigilance" of Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products
    • Commission Directive 2000/37/EC of 5 June 2000 amending Chapter VIa "Pharmacovigilance" of Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products. Official Journal of the European Communities. 2000;(L 139):25-27.
    • (2000) Official Journal of the European Communities , vol.L139 , pp. 25-27
  • 8
    • 84926458964 scopus 로고    scopus 로고
    • Commission Directive 2000/38/EC of 5 June 2000 amending Chapter Va (Pharmacovigilance) of Council Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products
    • Commission Directive 2000/38/EC of 5 June 2000 amending Chapter Va (Pharmacovigilance) of Council Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products. Official Journal of the European Communities. 2000;(L 139):28-30.
    • (2000) Official Journal of the European Communities , vol.L139 , pp. 28-30
  • 10
    • 84895298552 scopus 로고
    • Commission Directive 91/356/EEC, of 13 June 1991, laying down the principles and guidelines of good manufacturing practice for medicinal products for human use
    • Commission Directive 91/356/EEC, of 13 June 1991, laying down the principles and guidelines of good manufacturing practice for medicinal products for human use. Official Journal of the European Communities. 1991;(L 193):30-33.
    • (1991) Official Journal of the European Communities , vol.L193 , pp. 30-33
  • 12
    • 0038491312 scopus 로고    scopus 로고
    • John Wiley & Sons
    • The Journal of Gene Medicine. Gene Therapy Clinical Trials. John Wiley & Sons; 2001. Available at: http://www.wiley.co.uk/genetherapy/clinical/, accessed July 10, 2002.
    • (2001) The Journal of Gene Medicine
  • 14
    • 0003177157 scopus 로고    scopus 로고
    • Directive 2001/20/EC of the European Parliament and 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
    • Directive 2001/20/EC of the European Parliament and 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 of the European Communities. 2001;(L 121):34-44.
    • (2001) Official Journal of the European Communities , vol.L121 , pp. 34-44


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