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.

Updated on 25 April 2023
'Annual and multi-year reports' section

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. 

Surveys and roundtables

The 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. 

Outcomes of the survey and roundtables reports are available below:

Outcome of SME office survey on the implementation of the SME regulation - Commission Regulation (EC) No 2049/2005

Reference Number: EMA/277477/2020

Report on the European Medicines Agency roundtable with stakeholders - 15 years supporting SMEs

Reference Number: EMA/671119/2020

Outcome of SME office survey on the implementation of the SME regulation - Commission Regulation (EC) No 2049/2005

Reference Number: EMA/242286/2016

Report on the European Medicines Agency roundtable meeting with stakeholders - 10th anniversary of the SME initiative

Reference Number: EMA/821368/2015Summary:

To mark the 10th anniversary of the implementation of Commission Regulation (EC) No 2049/2005 (“SME Regulation”), the Agency held a meeting with representatives of stakeholder organisations on 27 November 2015.

Outcome of small and medium-sized enterprise (SME) office survey on the implementation of the SME regulation - Commission Regulation (EC) No 2049/2005

Reference Number: EMA/733642/2011

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

• SME documents
• SME events

For more information, see:

• Pharmaceutical industry

Annual and multi-annual reports

The 2023 annual report is available, highlighting main SME office findings, such as:

• 43% increase in the number of SME briefing meetings on regulatory strategy of medicine development
• 33% increase in the success rate for marketing authorisation applications for human medicines
• Strengthened collaboration with the European Innovation Council and SMEs Executive Agency
• Significant therapeutic advances achieved with SME-developed medicines, including Pedmarqsi, Aqumeldi and Loargys

Read the 2023 SME office annual report

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

Select the expandable panels to access the documents.

2021-22

Small and medium-sized enterprise (SME) Office annual report 2022

Small and medium-sized enterprise (SME) Office annual report 2021

2016-20

EMA's SME office report 2016-2020

Small and medium-sized enterprise (SME) Office annual report 2019

Small and medium-sized enterprise (SME) Office annual report 2018

Adopted

Small and medium-sized enterprise (SME) Office annual report 2017

Reference Number: EMA/123438/2018

Small and medium-sized enterprise (SME) Office annual report 2016

Reference Number: EMA/790421/2016

2013-15

Report on the 10th anniversary of the SME initiative

Reference Number: EMA/155560/2016

Small and medium-sized enterprise (SME) Office annual report 2014

AdoptedReference Number: EMA/699351/2014Summary:

The European Medicines Agency launched an initiative to provide financial and administrative assistance to micro, small and medium-sized enterprises (SMEs) in December 2005.

Small and medium-sized enterprise (SME) Office annual report 2013

AdoptedReference Number: EMA/716205/2013Summary:

The European Medicines Agency launched an initiative to provide financial and administrative assistance to micro, small and medium-sized enterprises (SMEs) in December 2005.

 

2006-11

Report on the small-and-medium-sized-enterprise initiative 2006-2011

AdoptedReference Number: EMA/956503/2011Summary:

The European Medicines Agency launched an initiative to provide financial and administrative assistance to micro, small and medium-sized enterprises (SMEs) on 15 December 2005