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Volumn 18, Issue 3-4, 2013, Pages 163-172

Orphan drugs: The regulatory environment

Author keywords

[No Author keywords available]

Indexed keywords

ORPHAN DRUG;

EID: 84873079257     PISSN: 13596446     EISSN: 18785832     Source Type: Journal    
DOI: 10.1016/j.drudis.2012.08.009     Document Type: Review
Times cited : (123)

References (42)
  • 2
    • 84873090150 scopus 로고    scopus 로고
    • Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on Rare Diseases: Europe's challenges no SEC-2008-2713 11 November 2008
    • Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on Rare Diseases: Europe's challenges no SEC-2008-2713 11 November 2008
  • 3
    • 65349108095 scopus 로고    scopus 로고
    • Orphan drug development is not taking off
    • R. Joppi Orphan drug development is not taking off Br. J. Clin. Pharmacol. 67 2009 494 502
    • (2009) Br. J. Clin. Pharmacol. , vol.67 , pp. 494-502
    • Joppi, R.1
  • 4
    • 78649700786 scopus 로고    scopus 로고
    • Rare diseases, orphan drugs and their regulation: Questions and misconceptions
    • E. Tambuyzer Rare diseases, orphan drugs and their regulation: questions and misconceptions Nat. Rev. Drug. Discov. 9 2010 921 929
    • (2010) Nat. Rev. Drug. Discov. , vol.9 , pp. 921-929
    • Tambuyzer, E.1
  • 5
    • 33644927240 scopus 로고    scopus 로고
    • Rare diseases and orphan drugs
    • J.K. Aronsom Rare diseases and orphan drugs Br. J. Clin. Pharmacol. 61 2006 243 245
    • (2006) Br. J. Clin. Pharmacol. , vol.61 , pp. 243-245
    • Aronsom, J.K.1
  • 6
    • 84873098296 scopus 로고    scopus 로고
    • Council recommendation of 8 June 2009 on an action in the field of rare diseases (2009/C 151/02)
    • Council recommendation of 8 June 2009 on an action in the field of rare diseases (2009/C 151/02)
  • 8
    • 84873090239 scopus 로고    scopus 로고
    • Regulation (EC) No. 141/2000 of the European Parliament and Council of 16 December 1999
    • Regulation (EC) No. 141/2000 of the European Parliament and Council of 16 December 1999
  • 9
    • 13144272331 scopus 로고    scopus 로고
    • Public Law 97-414, 4 January 1983 (US)
    • Orphan drug Act, Public Law 97-414, 4 January 1983 (US)
    • Orphan Drug Act
  • 10
    • 84873094575 scopus 로고    scopus 로고
    • Public Law 99, 91, 15 August 1985 (US)
    • Orphan Drug amendments of 1985, Public Law 99, 91, 15 August 1985 (US)
    • Orphan Drug Amendments of 1985
  • 11
    • 84873094575 scopus 로고    scopus 로고
    • Public Law 100-290, 18 April 1988 (US)
    • Orphan Drug amendments of 1988, Public Law 100-290, 18 April 1988 (US)
    • Orphan Drug Amendments of 1988
  • 13
  • 15
    • 84873089963 scopus 로고    scopus 로고
    • Singapore Medicines Act (Chapter 176-section 9) Medicines (Orphan drugs), 04 November 1991 (Singapore)
    • Singapore Medicines Act (Chapter 176-section 9) Medicines (Orphan drugs), 04 November 1991 (Singapore)
  • 16
    • 84873091247 scopus 로고    scopus 로고
    • Council Recommendation of 8 June 2009 on an action in the field of rare diseases (2009/C 151/02)
    • Council Recommendation of 8 June 2009 on an action in the field of rare diseases (2009/C 151/02)
  • 17
  • 18
    • 77954243603 scopus 로고    scopus 로고
    • Emergence of orphan drugs in the United States: A quantitative assessmnet of the first 25 years
    • M.M. Braun Emergence of orphan drugs in the United States: a quantitative assessmnet of the first 25 years Nat. Rev. Drug Discov. 9 2010 519 522
    • (2010) Nat. Rev. Drug Discov. , vol.9 , pp. 519-522
    • Braun, M.M.1
  • 19
    • 65549112639 scopus 로고    scopus 로고
    • Orphan drug legislation: Lessons for neglected tropical diseases
    • S. Villa Orphan drug legislation: lessons for neglected tropical diseases Int. J. Health Plan. Manage. 24 2008 27 42
    • (2008) Int. J. Health Plan. Manage. , vol.24 , pp. 27-42
    • Villa, S.1
  • 20
    • 85013611102 scopus 로고    scopus 로고
    • Japanese approach to orphan drugs
    • M. Narukawa Japanese approach to orphan drugs Pharm. Policy Law 3 2001 41 42
    • (2001) Pharm. Policy Law , vol.3 , pp. 41-42
    • Narukawa, M.1
  • 22
    • 79960998860 scopus 로고    scopus 로고
    • Orphan drug: Development trends and strategies
    • A. Sharma Orphan drug: development trends and strategies J. Pharm. Bioallied Sci. 2:4 2010 290 299
    • (2010) J. Pharm. Bioallied Sci. , vol.2 , Issue.4 , pp. 290-299
    • Sharma, A.1
  • 25
    • 84873089021 scopus 로고    scopus 로고
    • Regulation (EC) No. 847/2000 of the European Parliament and Council of 27 April 2000
    • Regulation (EC) No. 847/2000 of the European Parliament and Council of 27 April 2000
  • 26
    • 84873079064 scopus 로고    scopus 로고
    • Posada De La Paz Springer
    • Posada de la Paz Diseases Epidemiology 2010 Springer
    • (2010) Diseases Epidemiology
  • 27
    • 84873098674 scopus 로고    scopus 로고
    • Communication from the Commission: Guideline on aspects of the application of Article 8(2) of Regulation (EC) No 141/2000: review of the period of market exclusivity of orphan medicinal products-C (2008) 4051-17 September 2008
    • Communication from the Commission: Guideline on aspects of the application of Article 8(2) of Regulation (EC) No 141/2000: review of the period of market exclusivity of orphan medicinal products-C (2008) 4051-17 September 2008
  • 28
    • 85013580697 scopus 로고    scopus 로고
    • The regulation of orphan medicines in the EU: Objectives reached and main challenges when facing the future
    • K. Westermark The regulation of orphan medicines in the EU: objectives reached and main challenges when facing the future Pharm. Policy Law 9 2007 327 342
    • (2007) Pharm. Policy Law , vol.9 , pp. 327-342
    • Westermark, K.1
  • 29
    • 60749114770 scopus 로고    scopus 로고
    • Incentives for orphan drug research and development in the United States
    • E. Seoane-Vazquez Incentives for orphan drug research and development in the United States Orphanet. J. Rare Diss. 3 2008 1 7
    • (2008) Orphanet. J. Rare Diss. , vol.3 , pp. 1-7
    • Seoane-Vazquez, E.1
  • 30
    • 80053337529 scopus 로고    scopus 로고
    • Regulatory considerations for developing drugs for rare diseases: Orphan designations and early phase clinical trials
    • A.R. Pariser Regulatory considerations for developing drugs for rare diseases: orphan designations and early phase clinical trials Discov. Med. 11 2011 367 375
    • (2011) Discov. Med. , vol.11 , pp. 367-375
    • Pariser, A.R.1
  • 32
    • 80053379101 scopus 로고    scopus 로고
    • Estimating the budget impact of orphan medicines in Europe: 2010-2020
    • C. Schey Estimating the budget impact of orphan medicines in Europe: 2010-2020 Orphanet. J. Rare Dis. 6 2011 1 10
    • (2011) Orphanet. J. Rare Dis. , vol.6 , pp. 1-10
    • Schey, C.1
  • 33
    • 79955580019 scopus 로고    scopus 로고
    • European regulation on orphan medicinal products: 10 years of experiences and future perspectives
    • K. Westermark European regulation on orphan medicinal products: 10 years of experiences and future perspectives Nat. Rev. Drug Discov. 10 2011 341 349
    • (2011) Nat. Rev. Drug Discov. , vol.10 , pp. 341-349
    • Westermark, K.1
  • 34
    • 84887411214 scopus 로고    scopus 로고
    • Orphan drug pricing and payer management in the United States: Are we approaching the tipping point?
    • R. Hyde, and D. Dobrovolny Orphan drug pricing and payer management in the United States: are we approaching the tipping point? Am Health Drug Benefit 5 2012 1 6
    • (2012) Am Health Drug Benefit , vol.5 , pp. 1-6
    • Hyde, R.1    Dobrovolny, D.2
  • 35
    • 85013583312 scopus 로고    scopus 로고
    • The European regulation on orphan medicinal products
    • E. Cooke The European regulation on orphan medicinal products Pharm. Policy Law 3 2001 11 18
    • (2001) Pharm. Policy Law , vol.3 , pp. 11-18
    • Cooke, E.1
  • 36
    • 85013589057 scopus 로고    scopus 로고
    • The EU challenges on the designation of orphan medicinal products
    • J. Torrent-Farnell, and R. Morros The EU challenges on the designation of orphan medicinal products Pharm. Policy Law 3 2001 19 35
    • (2001) Pharm. Policy Law , vol.3 , pp. 19-35
    • Torrent-Farnell, J.1    Morros, R.2
  • 37
    • 84873077077 scopus 로고    scopus 로고
    • EMA Information on Procedure for orphan medicinal product designation-general principles (2009)-EMA/710915/2009-Rev. 5
    • EMA Information on Procedure for orphan medicinal product designation-general principles (2009)-EMA/710915/2009-Rev. 5
  • 38
    • 84873086223 scopus 로고    scopus 로고
    • Regulation (EC) No. 726/2004 of the European Parliament and Council of 31 March 2004
    • Regulation (EC) No. 726/2004 of the European Parliament and Council of 31 March 2004
  • 40
    • 84873077400 scopus 로고    scopus 로고
    • EC (2005) Marketing Authorisation, Notice to Applicants, Vol. 2A, European Commission
    • EC (2005) Marketing Authorisation, Notice to Applicants, Vol. 2A, European Commission
  • 41
    • 85013590966 scopus 로고    scopus 로고
    • Orphan medicinal products-the role of the EMEA
    • P. Le Courtois, and M. Carr Orphan medicinal products-the role of the EMEA Pharm. Policy Law 3 2001 31 35
    • (2001) Pharm. Policy Law , vol.3 , pp. 31-35
    • Le Courtois, P.1    Carr, M.2
  • 42
    • 84873094231 scopus 로고    scopus 로고
    • Communication from the Commission on Regulation (EC) No 141/200 of the European Parliament and of the Council on orphan medicinal products-(2003/C 178/02)-29 July 2003
    • Communication from the Commission on Regulation (EC) No 141/200 of the European Parliament and of the Council on orphan medicinal products-(2003/C 178/02)-29 July 2003


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