SME Regulation and reports

The main objective of the SME Regulation (Commission Regulation (EC) No 2049/2005) is to provide financial and administrative assistance to micro, small and medium-sized enterprises (SMEs) through the SME office, and address the needs of smaller companies in the pharmaceutical sector.

Support by the SME office is open to enterprises that:

  • have a valid SME status assigned by EMA;
  • develop and market medicines in the European Union (EU) and the European Economic Area (EEA).

The Regulation was adopted in December 2005 to promote innovation and the development of new medicines for human and veterinary use by SMEs. 

15-year anniversary of the SME Regulation

In June 2021, the European Medicines Agency (EMA) published a report to mark the 15-year anniversary of the adoption of the SME Regulation.

Between 2005 and 2020, more than 130 medicines developed by SMEs have been approved following an EMA recommendation and contribute to public and animal health. 

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Between 2016 and 2020:

  • the success rate for SME marketing authorisation 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; 
  • almost half of the authorised veterinary medicines developed by SMEs benefited from EMA scientific advice;
  • SMEs developed nearly 20% of all human medicines recommended for authorisation in 2020; half of these target a rare disease.

Achievements, challenges and opportunities for EU support to SMEs in the pharmaceutical sector are also highlighted in a report from a stakeholder roundtable on the 15-year anniversary of the SME Regulation and the SME office's 2020 survey of SMEs' experience with the SME Regulation.

More information:

SME office surveys and roundtables

The SME office runs surveys and roundtable discussions with pharmaceutical industry associations representing SMEs to get feedback on their experience with the SME Regulation, EMA's services for SMEs and the challenges faced by SMEs.

This aims to help guide EMA's future support activities for SMEs. 

The survey outcomes and roundtables reports available:

SME office annual and multi-year reports

An overview of SME office reports on the SME initiative.


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