Monday, 19 June 2017 17:14

New action plan to support SMEs as drivers of pharmaceutical innovation


The European Medicines Agency (EMA) has published an action plan for small and medium-sized enterprises (SMEs), which aims to foster innovation and support SMEs throughout all stages of medicine development in both the human and veterinary fields. The Agency’s SME Office has been providing active regulatory, financial and administrative support to registered SMEs since the implementation of the SME Initiative. The action plan builds on existing measures and addresses challenges of SMEs that were identified in the EMA’s report on the “10th Anniversary of the SME Initiative”, also taking into account EMA’s new framework for collaboration with academia and the EU-Innovation Network guidelines. The plan includes a series of new and enhanced actions for implementation in 2017-2020, and covers four main topics:

i) Raising awareness of the EMA SME initiative to stakeholders in the innovation lifecycle.

ii) Developing regulatory knowledge base of SMEs in the pharmaceutical sector.

iii) Fostering pharmaceutical innovation for human and veterinary medicines.

iv) Engaging with SMEs, partners and stakeholders, e.g.: in light of new medical device legislation and advances in pharmacogenomics/therapies.

The plan does not contain any action that would require changes to the Commission Regulation (EC) No 2049/2005. The implementation of the plan will be monitored through dedicated contact points across the operational divisions.

 More information: EMA News, Action plan10th Anniversary of the SME InitiativeEU Innovation Network