Other Committees
The Committee on Orphan Medicinal Products (COMP) administers the granting of orphan drug status (since 2000). Companies intending to develop medicinal products for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect not more than five in 10,000 persons in the European Union can apply for 'orphan medicinal product designation'. The COMP evaluates the application and makes a recommendation for the designation which is then granted by the European Commission.
The Committee on Herbal Medicinal Products (HMPC) assists the harmonisation of procedures and provisions concerning herbal medicinal products laid down in EU Member States, and further integrating herbal medicinal products in the European regulatory framework (since 2004).
The Paediatric Committee (PDCO) deals with the implementation of the pediatric legislation in Europe Directive (EC) No 1901/2004 (since 2007). Under this legistation, all applications for marketing authorization of new medicinal products, or variations to existing authorizations, have to either include data from pediatric studies (previously agreed with the PDCO), or to demonstrate that a waiver or a deferral of these studies has been obtained from the PDCO.
The Committee for Advanced Therapies (CAT) was established in accordance with Regulation (EC) No 1394/2007 on advanced-therapy medicinal products (ATMPs) such as gene therapy, somatic cell therapy and tissue engineered products. It assesses the quality, safety and efficacy of ATMPs, and follows scientific developments in the field.
A seventh committee, the Pharmacovigilance Risk Assessment Committee (PRAC) has come into function in 2012 with the implementation of the new EU pharmacovigilance legislation (Directive 2010/84/EU).
Read more about this topic: European Medicines Agency
Famous quotes containing the word committees:
“What lies behind facts like these: that so recently one could not have said Scott was not perfect without earning at least sorrowful disapproval; that a year after the Gang of Four were perfect, they were villains; that in the fifties in the United States a nothing-man called McCarthy was able to intimidate and terrorise sane and sensible people, but that in the sixties young people summoned before similar committees simply laughed.”
—Doris Lessing (b. 1919)
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—C. Northcote Parkinson (1909–1993)