On 31th May, 2017 the European Medicines Agency (EMA) published an action plan for small and medium-sized enterprises (SMEs), which aims to foster innovation and support SMEs in the development of novel human and veterinary medicines.

This action plan builds on existing measures introduced to support SMEs pursuant to Commission Regulation (EC) No 2049/2005 and addresses the challenges identified by SMEs in a report published by EMA on the 10th Anniversary of the SME initiative.

A key point of the plan is the strengthening of the collaboration between SMEs and academia, in the light of its role in pharmaceutical innovation and the new EU innovation Network, as well taking into account the new EMA’s framework for collaboration with academia.

The plan covers four key areas and lists a series of new and enhanced actions:

  1. Awareness of EMA’s SME initiative: actions include stepped-up engagement with actors in the pharmaceutical innovation environment such as incubators, universities and investors.
  2. Training and education: actions include training for SMEs and academia, and expanding the EU Network Training Centre.
  3. Support the development of innovative medicines: actions include maximising the use by SMEs of regulatory tools to support the development of and access to medicines for unmet medical needs; providing assistance to academia; and enhancing cooperation with EU partners on projects subject to EU funding.
  4. Engagement with SMEs, EU partners and stakeholders: actions include contributing to the development of the EU Innovation Network, EU initiatives supporting SMEs and start-ups in relation to funding and administrative burden (Europe’s next leaders: the Start-up and Scale-up Initiative), and interacting with international regulatory authorities.

EMA, through its SME office, is always proactive to support SMEs throughout all stages of medicine development, providing active regulatory, financial and administrative assistance. More than 1700 companies are currently registered with the Agency operating in the human and veterinary fields.

On 31 May 2017, EMA also published its SME office 2016 annual report, providing an overview of SME-related activities in 2016 and highlighting incentives and platforms that SMEs can leverage to advance innovative developments and regulatory strategies.

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