
European Medicines Agency Revises Orphan Drugs Policy
EMA revises its polices on fee reductions for orphan drugs for 2014.
The European Medicines Agency has revised its policy on
EMA has listed the following fee reductions for non-SMEs in 2014:
- 75% fee reduction for non-pediatric-related initial and follow-up protocol assistance (currently a 40% fee reduction)
- 100% fee waiver for pediatric-related initial and follow-up protocol assistance (no change from 2013)
- 10% fee reduction for initial marketing-authorization applications (currently no fee reduction)
- 100% fee reduction for pre-authorization inspections (currently no fee reduction).
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
- Post-authorization applications and annual fees in the first year of marketing authorization.
Source:
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