EMEA/EUROPEAN COMMISSION PHARMACEUTICAL NEWS IN BRIEFS
September 1st, 2008
BY KEITH NUTHALL
THE EUROPEAN Commission has issued guidance on defining an orphan medicine, which benefits from a longer duration of protected European Union market sales. The advice tries to establish how different a drug must be from an authorised medicine to be considered a new 'orphan'. See http://ec.europa.eu/enterprise/pharmaceuticals/orphanmp/doc/c_2008_4077.pdf. The Commission has also released guidelines on manufacturing radiopharmaceuticals - http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-4/2008_09_annex3.pdf.
*Meanwhile the European ...
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