Keep It Simple: EU Consults On Future Design Of EMA’s Fee System
Following a report that identified several shortcomings of the European Medicines Agency fee system, the European Commission has suggested various options to make it sustainable and future-proof.
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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.
Differences Put Aside As ICH Finalizes Guide On Post Approval Changes
An international guideline on managing post approval changes to drugs, which was initially criticized because of its incompatibility with legal frameworks in certain ICH regions such as the EU, has been finalized.
Single Annual EMA Fee Proposal Holds Most Promise For Pharma
Europe’s research-based industry association picks its preferred way forward for simplifying the European Medicines Agency’s fee system.