The European Medicines Agency has introduced a simplified process for handling requests from companies that wish to register as micro, small or medium-sized enterprises (SMEs). The process expected to reduce the administrative burden on companies and to speed up the SMEs assignment and renewal process.

A simplified process for handling requests from companies that wish to register as micro, small or medium-sized enterprises (SMEs) has been introduced by the European Medicines Agency (EMA). Thanks to the new method, EMA expects to reduce the administrative burden on companies and to speed up the SMEs assignment and renewal process. Last Mars 2011, EMA put also in place a new EU online register which grants access to information on authorised pharmaceutical clinical trials.

The Agency announced that among the new modalities there is the move to electronic-only submissions; introduction of an ownership checklist to improve accuracy of submissions; a risk-based approach to the Agency's review process, reducing the number of submission that need to be checked; and the replacement of formal SME qualification documents with electronic versions.

Currently, more than 600 companies are currently registered as SMEs with the Agency. EMA works with SMEs through its SME office. The office is dedicated to addressing the particular needs of smaller companies, in order to promote innovation and the development of new medicines for human and veterinary use by SMEs. Companies registered as SMEs with the Agency receive a number of incentives, including reduced fees for applications to the Agency, scientific advice and inspections.