Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors


Incentives for smaller medicines makers

Written by | 26 Oct 2012 | All Medical News

by Gary Finnegan – Emerging uses of EMA Approved Drugs –

Over 1,000 small and medium enterprises (SMEs) have now registered with European Medicines Agency SME office. The Agency launched its SME initiative in December 2005 to encourage smaller players to bring potential new medicines to market in recognition of their role in driving innovation in the pharmaceutical sector.

SMEs benefit from a number of incentives, including regulatory assistance from the SME office, and reduced fees for certain Agency procedures such as scientific advice and inspections.

Small and medium-sized applicants account for around 10% of centralised marketing-authorisation applications for human medicines and 20% of veterinary applications. There has been a surge in the number of companies submitting SME declarations to the Agency this year, with a 48% increase since the end of 2011.

In total, the registered SMEs have approximately 2,600 medicines at various stages of development. Approximately half of the products developed by SMEs are chemical entities and one quarter is biological medicines, including advanced therapies.

Newsletter Icon

Subscribe for our mailing list

If you're a healthcare professional you can sign up to our mailing list to receive high quality medical, pharmaceutical and healthcare E-Mails and E-Journals. Get the latest news and information across a broad range of specialities delivered straight to your inbox.


You can unsubscribe at any time using the 'Unsubscribe' link at the bottom of all our E-Mails, E-Journals and publications.