PHARMA SECTOR THINKS HARD OVER UPCOMING EU REFORM OF ORPHAN MEDICINE CONTROLS

Important changes in the way that the European Union (EU) deals with orphan medicines could be signalled later this year when the European Commission publishes a revised version of its 2003 Communication (policy paper) on the topic. The Commission has said wants to "streamline the regulatory framework” underpinning the assistance given to manufacturers of orphan drugs and to adapt the policy to “technical progress", and asked for comments from the pharma industry and other interested parties on how it should proceed. In its preliminary text put out for ...


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