EU Ministers Want More Targeted Approach To New EMA Fees
Proposals for a new cost-based fee structure at the European Medicines Agency are to be discussed by EU member state health ministers next week, with calls for more targeted fee rises for specific services on the agenda.
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New EU Fee System To Give Pharma Firms More Predictability
The publication of a draft EU Regulation governing the fees paid by the pharmaceutical industry to the European Medicines Agency is the latest step in a long process aimed at ensuring that the payment system better reflects the actual costs of the regulatory work carried out or coordinated by the EU regulator.
EU Review Proposals ‘Fail To Analyze’ Impact Of Reduced Exclusivity Periods
Plans for the overhaul of the EU’s medicines framework are missing key analysis on the effect of reductions in data and market protection on the pharmaceutical industry, despite an abundance of studies on how such incentives influence company decisions on whether to develop new products, say lawyers from Sidley.
EU Commission Again Delays Pharma Revision Proposals, Citing ‘Busy Agenda’
Two members of the European Parliament claim the latest delay to publication of the long-awaited legislative revision is the result of pressure from the pharmaceutical industry.