BioWorld International Correspondent

LONDON - The European Medicines Agency (EMEA) opened a new office to provide a one-stop regulatory shop for small companies and announced reductions in fees and new services to make it easier for SMEs to get marketing approval for new drugs. Up to 1,500 companies will be eligible for the discounts.

There will be a 90 percent reduction in fees for scientific advice and inspections, while fees for administrative services will be abolished and payments for marketing authorization applications will be deferred until the end of the evaluation process. The fees will be waived for SMEs that have requested and followed EMEA's scientific advice procedure but do not receive marketing authorization. In addition, EMEA will take on responsibility for translating package information into different European languages.

The services and reduced fees are part of new pharmaceutical legislation relating to SMEs that were approved Dec. 15. They follow complaints that the centralized system for registering pharmaceuticals in the 25 member states was not designed in the interests of small companies and was more cumbersome and more expensive than national medicines agencies. To qualify for the discounts and use the services, companies must meet the definition of an SME, a status that will be reviewed annually.

EuropaBio, the pan European biotech industry body, has been a driving force in pushing for the legislation. Andrea Rappagliosi, chairman of its Healthcare Council, said the move "shows a very real recognition of the strategic role of European SME biotech companies."

Spiro Rombotis, CEO of Cyclacel, told BioWorld International he welcomes all steps that the European Commission and the European member states can make to reduce the fees burden, but said that "while it would be unreasonable if there were different rules for biotech from pharma, time to approval is the key issue. That's what would really make the difference."

The SME office is based at EMEA's headquarters in London and will be headed by Melanie Carr, previously at the agency's orphan drugs unit. The office will introduce a mentoring system at which advice can be obtained by an SME on any issue, throughout the development process.

EuropaBio is setting up an EMEA-SME task force to oversee introduction of the new rules and provide feedback from its members to the agency. It also is planning to publish a user guide to the new legislation at the beginning of 2006.