EU Fees Revision A ‘Once-In-A-Generation’ Chance To Solve Resource Challenges
COVID-19 and Brexit have put a great strain on the resources of the EU medicines regulatory system, but the planned review of the EU fee system could produce a system that is more flexible, efficient and better able to respond rapidly to emerging technologies and the needs of health care systems, says EFPIA.
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Swedish EU Presidency Promises Action On Pharma Law Revision, EMA Fees & AMR
Health care and medicines are among the priorities outlined by the new presidency of the Council of the EU for the first half of 2023.
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.