The savings will apply to fees for post-authorisation activities. SMEs will receive a 40% reduction in charges and micro-sized companies will pay nothing.
The reductions will apply when drug developers do the following:
- extend or renew a marketing authorisation for a drug,
- submit type-IA, type-IB or type-II variations (minor or major changes to marketing authorisations which do not involve changes to the API or delivery method),
- transfer marketing authorisation between two SMEs,
- initiate a “referral procedure” to address a safety concern or resolve a disagreement on drug authorisation between EU member states,
- pay their annual post-authorisation fee.
The EMA said it had slashed these costs in response to concerns from SMEs about the burden of post-authorisation fees on small businesses.
The exemptions add to the financial and administrative incentives Europe already awards SMEs in their pre-authorisation and marketing authorisation phases, which the agency says are intended to promote innovation in the interest of public health. These include fee reductions for scientific advice throughout a medicine’s lifecycle, outreach programmes, and topical workshops.
According to EMA figures, SMEs developed more than 60% of authorised EU medicines for rare diseases between 2010 and 2012, making them a major driver of innovation in drug development. Additionally, three-quarters of advanced therapy medicines on the European market come from SMEs.
More changes to come
The financial changes follow a major restructuring of the EMA which took effect on April 1. Under the revisions, the EMA has streamlined the way it reviews drug applications and assesses manufacturing facilities.
The most noticeable difference for pharmaceutical companies, it said, would be a change in their contact person at the EMA. Further, unnamed restructuring is planned throughout the rest of the year.
There are 1,100 SMEs publicly registered with the EMA. Of these, 44% are classed as micro-sized (with fewer than 10 staff), 39% are small (fewer than 50 employees) and 17% are medium-sized (under 250 staff members).