Difference between revisions of "Orphan Drugs"
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Regulating drugs for rare diseases is a carefully monitored process by the unit. A main feature of this is providing guidelines for sponsers on how to apply for orphan medicinal product designation to transfer drugs to the European Medicines Agency (EMEA). This is a step that has not only been taken by the European Commission and the EMEA acting within it; the United States and [[Food and Drug Administration]] (FDA) also have adopted a common applcation that sponsers must fill out in the request to transfer orphan products intended for rare diseases in the EU and US. <ref> | Regulating drugs for rare diseases is a carefully monitored process by the unit. A main feature of this is providing guidelines for sponsers on how to apply for orphan medicinal product designation to transfer drugs to the European Medicines Agency (EMEA). This is a step that has not only been taken by the European Commission and the EMEA acting within it; the United States and [[Food and Drug Administration]] (FDA) also have adopted a common applcation that sponsers must fill out in the request to transfer orphan products intended for rare diseases in the EU and US. <ref> | ||
Orphan medicinal products http://ec.europa.eu/enterprise/pharmaceuticals/orphanmp/index.htm Accessed 29/02/08 </ref> | Orphan medicinal products http://ec.europa.eu/enterprise/pharmaceuticals/orphanmp/index.htm Accessed 29/02/08 </ref> | ||
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Latest revision as of 23:17, 3 March 2008
Regulating drugs for rare diseases is a carefully monitored process by the unit. A main feature of this is providing guidelines for sponsers on how to apply for orphan medicinal product designation to transfer drugs to the European Medicines Agency (EMEA). This is a step that has not only been taken by the European Commission and the EMEA acting within it; the United States and Food and Drug Administration (FDA) also have adopted a common applcation that sponsers must fill out in the request to transfer orphan products intended for rare diseases in the EU and US. [1]
Notes
- ↑ Orphan medicinal products http://ec.europa.eu/enterprise/pharmaceuticals/orphanmp/index.htm Accessed 29/02/08
