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 2 May:
'Annual and multi-annual 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.

The office conducted in 2024 an online survey aimed at SMEs and industry stakeholders on the support, services and incentives that EMA provides to them.

EMA will analyse the results and report them anonymously at a roundtable meeting with SME stakeholders in 2025. The office will later make available a report with the main outcomes.

Outcomes of previous surveys 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 2024 annual report is available, highlighting key achivements, such as:

• Increased success rates for marketing authorisations submitted by SMEs
• Higher SME registration figures, especially for veterinary companies
• Increased regulatory assistance
• High representation of SMEs in PRIME products and scientific advice received for orphan medicines

The report also highlights the SME office's role in:

• supporting innovative developments;
• offering training and education to SMEs;
• engaging with stakeholders.

Read the 2024 SME office annual report

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

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

2021-23

Small and medium-sized enterprise (SME) office annual report 2023

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