European Medicines Agency simplifies SME assignment process

28 October 2011

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 new process, which is based on more than five years of experience of working with SMEs, is expected to reduce the administrative burden on companies and to speed up the SME assignment and renewal process. The simplifications include:

• a 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;
• replacement of formal SME qualification documents with electronic versions.

Companies registered as SMEs with the Agency receive a number of incentives, including reduced fees for applications to the Agency, scientific advice and inspections. More than 600 companies are currently registered as SMEs with the Agency.

The Agency works with SMEs through its SME office. The office, which was established in 2005, 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.