EMA sets greater fee-reduction rates for orphan medicines in 2014
The European Medicines Agency’s policy on fee reductions for orphan medicinal products has been revised. The changes, which take effect as of January1, 2014, will provide enhanced fee reductions for companies that are not micro, small or medium-sized enterprises (SMEs).
In addition, as recommended by the Agency’s Committee for Orphan Medicinal Products (COMP), the policy will continue to focus primarily on assistance to SMEs with the objective of providing incentives to support research and innovation on medicines intended for the diagnosis, prevention or treatment of rare diseases.
Fee reductions for non-SMEs
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