According to the EMA, SME Designation has allowed for improved success rate for organizations seeking regulatory approvals:

  • the success rate for SME marketing authorization applications for human medicines more than doubled, reaching 89% in 2020;
  • more than 4 in 10 medicines selected for EMA's PRIME: priority medicines scheme were from SMEs;
  • SMEs developed nearly 20% of all human medicines recommended for authorization in 2020; half of these target a rare disease.