Incentives for smaller medicines makers

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.