EMA Simplifies SME Assignment Process

The new process is expected to reduce the administrative burden on companies and to speed up the SME assignment and renewal process.

The European Medicines Agency has introduced a simplified process for handling requests from companies that wish to register as micro, small or medium-sized enterprises (SMEs).

The new process, which is based on more than five years of experience of working with SMEs, is expected to reduce the administrative burden on companies and to speed up the SME assignment and renewal process. The simplifications include: a move to electronic-only submissions; introduction of an ownership checklist to improve accuracy of submissions; a risk-based approach to the Agency's review process, reducing the number of submission that need to be checked; replacement of formal SME qualification documents with electronic versions.

Companies regist