Search Results for Orphan Regulation

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European Commission Clears up Questions on Orphan Drug Regulation By Michael Mezher - Published 05 January 2017

Following a public consultation in November 2015, the European Commission (EC) has released a new communication intended to clarify some lingering questions about the EU's Orphan Regulation.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Orphan products

Tags: Orphan Regulation, Orphan Drugs, Orphan Designation

Regulators, Industry Weigh in on Proposed EU Orphan Regulation Changes By Zachary Brennan - Published 07 March 2016

As the number of orphan drug approvals continues to rise in the EU, the European Commission is now considering feedback from European governments, regulators and industry on how changes to five aspects of the Orphan Regulation may further incentivize the development of drugs for rare diseases.

Categories: News, Europe, EC, EMA, MHRA, Drugs, Government affairs, Orphan products

Tags: orphan drugs, Orphan Regulation, EC consultation, rare disease drugs