On the occasion of the 10-year anniversary of the SME initiative, the European Medicines Agency published a 10-page Action Plan Document for SMES, and “which aims to foster innovation and support SMEs in the development of novel human and veterinary medicines”.
This report, which addresses the challenges identified by European SMEs, 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.