The changes will provide enhanced fee reductions for companies that are not micro, small or medium-sized enterprises (SMEs) and will be in effect from 1 January 2014.
According to the EMA, the following fee reductions will apply for non-SMEs in 2014:
- "75% fee reduction for non-paediatric-related initial and follow-up protocol assistance (currently a 40% fee reduction);
- 100% fee waiver for paediatric-related initial and follow-up protocol assistance (no change from 2013);
- 10% fee reduction for initial marketing-authorisation applications (currently no fee reduction);
- 100% fee reduction for pre-authorisation inspections (currently no fee reduction). "
The EMA's policy on fee reductions for orphan medicines primary objective will continue to be to assist SMEs in the "research and innovation of medicines intended for the diagnosis, prevention or treatment of rare diseases." Therefore, the following will remain free-of-charge for SMEs in 2014:
- "all initial and follow-up protocol assistance;
- initial marketing-authorisation applications;
- pre-authorisation inspections;
- post-authorisation applications and annual fees in the first year of marketing authorisation."