FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs / Submissions and Approvals

EMA Provides New Financial Perks for Large Orphan Drugmakers

Dec. 5, 2013

In a boost for Big Pharma, the European Medicines Agency (EMA) has raised the fee-reduction rate for non-small and medium-sized enterprises (SMEs) seeking assistance on non-pediatric-related protocol from 40 percent to 75 percent, in line with recommendations by the agency’s orphan medicinal products panel.

The new reductions will take effect Jan. 1, 2014.

The 100-percent fee waiver on pediatric-related initial and follow-up protocol assistance for large companies remains the same. However, the EMA has introduced a 10-percent fee reduction for initial marketing authorization applications and a 100-percent fee reduction for pre-authorization inspections.

The EMA on Tuesday also confirmed that the following services will remain free-of-charge for SMEs in 2014:

  • All initial and follow-up protocol assistance;
  • Initial marketing-authorization applications;
  • Pre-authorization inspections; and
  • Post-authorization applications and annual fees in the first year of authorization. — Lena Freund

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