Cancer And Rare Diseases Top EU Drug Approvals In 2015
This article was originally published in Scrip
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The EU Orphan Regulation and the Paediatric Regulation have helped to increase the number of products developed for rare diseases and children, but they both have some shortcomings that need to be addressed, according to an evaluation of the legislation carried out by the EU authorities. The European pharmaceutical industry has warned against opening up the legislation, saying it is “critical to maintain a stable and predictable incentives framework."
A product that was initially turned down for marketing approval in the EU has now been given the green light for use on the National Health Service in Scotland, following a similar recommendation in England late last year.
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