Small biopharmaceutical companies are powerful engines of innovation, however, typically lack the resources, funding and expertise compared to big pharma companies. The European Medicines Agency (EMA) addresses the unique needs of micro, small and medium-sized enterprises (SMEs) through specific incentives – accessible through the SME status. For example, the most immediate and obvious incentive for early development stages is to save 90 % or more of the scientific advice fee which could go up to 80,000 EUR. SMEs inside and outside of the EU can obtain EMA’s SME status if certain criteria are fulfilled.
Annegret Vaggelas explains the requirements, the incentives, and the process to obtain the SME status.