1. Scientific advice for orphan drugs: Critical points and perspectives
- Author
-
Jordi Llinares Garcia
- Subjects
medicine.medical_specialty ,business.industry ,Health Policy ,As is ,Alternative medicine ,Public administration ,Advice (programming) ,Orphan drug ,Incentive ,Human use ,medicine ,European commission ,Socioeconomics ,business ,Pharmacology, Toxicology and Pharmaceutics (miscellaneous) - Abstract
The orphan designation procedure relates to medicinal products for human use aimed at the treatment, prevention or diagnosis of diseases. It is a free of charge procedure and can be requested at any stage of the development by a sponsor who can be either a company or an individual, as long as is established in EU, Iceland, Liechtenstein, and Norway. Once the Committee for Orphan Medicinal Products (COMP) adopts opinion on designation, the European Commission grants a decision that gives access to the incentives.
- Published
- 2010
- Full Text
- View/download PDF