For the first time since the launch of its SME initiative in December 2005, there are now more than 1000 micro, small and medium-sized enterprises (SMEs) registered with the European Medicines Agency.
Companies registered as SMEs with the Agency have access to a number of incentives, including regulatory assistance from the SME office, and reduced fees for certain Agency procedures such as scientific advice and inspections. The Agency recognises the fact that SMEs are a major driver of innovation in the pharmaceutical industry.
SME applicants currently account for around 10% of centralised marketing-authorisation applications for human medicines and 20% of veterinary applications.
2012 has seen a surge in the number of companies submitting SME declarations to the Agency, with a 48% increase since the end of last year. This indicates a high level of activity in the pharmaceutical sector, but is also a reflection of the new pharmacovigilance legislation coming into operation.
A high proportion of companies registering recently have sought SME status in relation to EudraVigilance, the European Union information system for the management of safety reports. A Medical Dictionary for Regulatory Activities (MedDRA) fee waiver is available to micro and small enterprises, and there are reduced fees for EudraVigilance training for all SMEs.
The majority of registered SMEs (76%) have medicines for human use under development, 4% are developing medicines
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