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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