The orphan medicinal products: An international challenge

Minerva Biotecnologica

Volumn 15, Issue 2, 2003, Pages 161-166

  Meyers, A ^a   Lipucci di Paola, M ^b  

^a National Organization for Rare Disorders   (United States)

^b Europ Org for Rare Dis (EURORDIS)   (France)

Author keywords

Orphan drug production

Indexed keywords

ORPHAN DRUG;

ARTICLE; AUSTRALIA; DRUG APPROVAL; DRUG INDUSTRY; DRUG INFORMATION; DRUG MARKETING; DRUG RESEARCH; ECONOMIC ASPECT; EUROPE; FINANCIAL MANAGEMENT; HEALTH CARE POLICY; JAPAN; LEGAL ASPECT; PATENT; POLITICS; PUBLIC HEALTH SERVICE; UNITED STATES; WORLD HEALTH ORGANIZATION;

EID: 0242720358     PISSN: 11204826     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (18)

1. FDA website: http://www.fda.gov.
2. Orphan Drug Act (Public Law 97-414), 1983.
3. National Organization Rare Disorders (NORD). Website: http://www.rarediseases.org.
4. NORD Guide to Rare Disorders. Philadelphia: Lippincott Williams & Wilkins; 2003.
5. Haffner ME, Whitley J, Moses M. Two decades of orphan product development. Nat Rev Drug Discov 2002;1:821-5.
6. National Institutes of Health. Website: http://www.hih.gov.
7. The Rare Diseases Act of 2002 (Public Law 107-280), 2002.
8. The Rare Diseases Orphan Products Development Act of 2002 (Public Law 107-281), 2002.
9. European Organization Rare Disorders (EURORDIS). Website: http://www.eurordis.org.
10. Programme of Community Action on Rare Diseases (OJ L 155, 22-06-1999), 1999.
11. Regulation (EC) No. 141/2000 of the European Parliament and of the Council on Orphan Medicinal Products (OJ L 18/1, 22-01-2000), 2000.
12. European Medicinal Evaluation Agency (EMEA). Website: http://www.emea.eu.int.
13. Community Register of Orphan Medicinal Products. Website: http://pharmacos.eudra.org/F2.
14. The Dutch Steering Committee Orphan Drugs. Website: http://www.orphandrugs.nl.
15. Italian National Institute of Health (ISS). Website: http://www.malattierare.iss.it.
16. Italian Ministry of Health. Website: http://www.sanita.it.
17. Federacion Espanola de Enfermedades Raras (FEDER). Website: http://wwv.minoritarias.org.
18. Alliance Maladies Rares. Website: http://www.alliance-maladiesrares.org