European Medicines Agency Revises Orphan Drugs Policy - Pharmaceutical Technology

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European Medicines Agency Revises Orphan Drugs Policy


The European Medicines Agency has revised its policy on fee reductions for orphan drugs.  The changes provide enhanced fee reductions for companies that are not micro, small, or medium-sized enterprises (SMEs) and will take affect on January 1, 2014. The policy will continue to focus 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, as recommended by EMA’s Committee for Orphan Medicinal Products (COMP). Current fee-reduction rates will still apply to applications received by EMA until Dec. 31, 2013.
 
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: European Medicines Agency

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