Small and Medium-Sized Enterprise (SME)

The European Medicines Agency (EMA) provides various incentives and support mechanisms for Small and Medium-sized Enterprises (SMEs) involved in clinical development. These incentives aim to facilitate drug development and bring innovative treatments to the market more efficiently. Additionally, the EMA offers expedited development programs to speed up the availability of important new drugs.

A non-EU sponsor has to appoint a so-called “Regulatory Consultancy” in the EU to support the SME status applications according to the Commission Recommendation 2003/361/EC concerning definition of micro, small, and medium-sized enterprises. The SME status of the non-EU sponsor will be linked to the SME status of its “Regulatory Consultancy”.