On 15 December 2025, Commission Regulation (EC) No 2049/2005 will reach its 20th anniversary. The regulation addresses the unique needs of small and medium-sized enterprises (SMEs) and promotes innovation and the development of new medicines for human and veterinary use by SMEs. In light of this important milestone, EMA is conducting this survey to receive feedback from SMEs and EU trade associations on the implementation of the regulation.

The questionnaire is opened to SMEs and industry stakeholder organisations for a 6-week public consultation (closing date on 12 July 2024). Contributions are sought from SMEs and enterprises, authorities, investors, academic organisations and individuals engaging with SMEs in the pharmaceutical sector.

Your feedback is important and will allow us to understand current issues faced by SMEs and help us tailor future activities to the needs of SMEs.

The survey results will be reported anonymously at a roundtable meeting with stakeholders planned in 2025 and published on EMA’s website.

The survey can be found at the following link: https://ec.europa.eu/eusurvey/runner/SME-survey-2024

Should you have any questions about the survey, please do not hesitate to contact the SME Office (sme@ema.europa.eu).