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The SME Action Plan 

19 th Jun The SME Action Plan 

TRAC - The Regulatory Affairs Consultancy

The SME Action Plan


The European Medicines Agency (EMA) launched the Small and Medium Enterprise (SME) initiative in December 2005. Ten years on, the EMA reviewed whether they provide adequate support and an appropriate regulatory environment for those that drive innovation including SMEs and academia in their 10 year SME report. You can find a summary of that report in our previous blog post, here.

Following this, in May 2017 the EMA published an action plan, outlining a series of objectives and actions which were identified in the EMA 10 year report and the SME survey. This report tackles the following four areas:

– Awareness of EMA’s SME initiative

– Training and education (for SMEs and academia)

– Support to the development of innovative medicines, in particular by facilitating the use of regulatory tools, providing assistance and enhancing cooperation with EU partners on projects subject to EU funding

– Engagement with SMEs, EU partners and stakeholders, inter alia via the EU Innovation Network and EU initiatives supporting SMEs and start-ups regarding funding and administrative burden.

In addition, the EMA also published its SME office annual report for 2016, which provides an overview of the SME related activities at the European Medicines Agency in 2016.

Read the action plan


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