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16 actions identified for implementation in 2017-2020

The European Medicines Agency (EMA) yesterday 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.

SMEs are the backbone of Europe's economy. They represent 99% of all businesses in the European Union (EU) and provide two-thirds of total private sector employment. In the pharmaceutical sector SMEs are a motor of innovation and play a major role in the development of new medicines.

To support SMEs throughout all stages of medicine development, EMA’s SME Office provides active regulatory, financial and administrative support to registered SMEs. More than 1,700 companies are currently registered with the Agency operating in the human and veterinary fields.

The action plan builds on the experience gained and addresses the challenges identified by SMEs in a report published by EMA on the 10th Anniversary of the SME initiative.

It also takes into account EMA’s new framework for collaboration with academia, which aims to strengthen its interaction with the academic world in light of its role in pharmaceutical innovation, and the new EU Innovation Network.

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 has also published its SME office 2016 annual report. This report provides an overview of SME-related activities in 2016 and highlights incentives and platforms that SMEs can leverage to advance innovative developments and regulatory strategies.