SME Regulation and reports

The main objective of the small and medium-sized enterprises (SME) Regulation (Commission Regulation (EC) No 2049/2005) is to provide financial and administrative assistance to these enterprises through the SME office of the European Medicines Agency (EMA). It also aims to address the needs of smaller companies in the pharmaceutical sector.
HumanRegulatory and procedural guidanceSME

Updated on 7 July:
‘Surveys and roundtables’ section to include an outcome report for a 2024 online survey for SMEs and pharmaceutical industry stakeholders

Support by EMA's 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 adopted in December 2005 promotes innovation and the development of new medicines for human and veterinary use by SMEs. 

Surveys and roundtables

EMA's SME office runs surveys and roundtable discussions with pharmaceutical industry associations representing SMEs. This is to get feedback on their experience with the regulation, EMA's related services and the challenges SMEs face.

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

A report is available on the main outcomes of a survey that the office conducted to assess the services and incentives it provides to stakeholders. 

EMA reports such outcomes at roundtable meetings. 

The office carried out this online survey in 2024.

Select the expandable panel below to access previous surveys and roundtables reports:

 

 

 

 

 

 

 

 

 

 

 

 

To find more reports and supporting documents on the office's activities, as well as upcoming events, go to:

For more information, see:

Annual and multi-annual reports

Find below an overview of the previous SME annual reports by year.

Select the expandable panels to access the documents (via de arrow symbol):

 

Share this page