RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > EMA Announces User Fee Reductions for Orphan Drugs

EMA Announces User Fee Reductions for Orphan Drugs

Posted 03 December 2013 | By Alexander Gaffney, RAC

Developing pharmaceutical or biotechnology products for use in orphan populations in the EU is about to get even cheaper, regulators have announced.

Orphan designation status is currently given by EU regulators to products intended for life-threatening conditions that occur in no more than five in 10,000 persons in the EU, and is meant to incentivize the development of drugs which would not ordinarily have a natural market for product testing and development.

Sponsors of products given the designation enjoy a host of benefits, including additional regulatory assistance and scientific advice, additional market exclusivity and reduced filing costs.

On 19 November 2013, the European Medicines Agency's (EMA) Executive Director Guido Rasi issued a notice announcing that industry-paid user fees-ordinarily paid to defray EMA's costs of reviewing a marketing authorization application (MAA)-for orphan medical products would be further reduced in the coming year relative to 2013 levels.

At present, fee reductions are mostly given to small and medium-sized enterprises (SMEs), which are able to file MAAs for orphan drugs free of charge. They also pay nothing for initial and follow-up protocol assistance, pre-authorization inspections and post-authorization applications and annual fees for the first year after authorization.

Non-SMEs, however, have not been given the same benefits, and in some cases have no benefit relative to filing a non-orphan drug application.

But under Rasi's new order, non-SMEs will be given a host of new fee reductions that should help to defray the costs of regulatory review for the sponsor. Sponsors will now be required to pay just 25% of the usual cost of regular protocol assistance (currently 60%), 90% of the usual MAA user fee (currently 100%) and nothing for pre-authorization inspections (currently 100%).

The fee reductions will go into effect on 1 January 2014, EMA wrote. Any applications received prior to that date will be subject to the 2013 submission rates.

EMA Announcement on Orphan Fee Reductions

Regulatory Focus newsletters

All the biggest regulatory news and happenings.