EMA - User guide for micro, small and medium-sized enterprises

The guide helps companies navigate the regulatory requirements and incentives available throughout a medicine's product lifecycle. It provides an overview of procedures to support research and development activities, and improves understanding of what is needed to obtain a marketing authorisation in the European Union (EU) / European Economic Area (EEA). The updates concerns the Upcoming legislative changes, the incentives offered by EMA to SMEs, the PRIority MEdicines (PRIME) scheme for hum...