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Regulatory News | 31 May 2017 | By Zachary Brennan
The European Medicines Agency (EMA) on Wednesday published an action plan for the next three years to help small and medium-sized pharmaceutical companies.
The plan seeks to support such companies through all stages of drug development and to further engage with sectors adjacent to pharmaceuticals (e.g. companion diagnostic technologies, medical technologies industries and digital health) in light of Europe’s new medical device legislation, advances in pharmacogenomics and advanced therapies.
EMA notes that the action plan builds on challenges identified by small and medium-sized enterprises (SMEs) and outlined in an EMA report on the 10th anniversary of the SME initiative. It also takes into account EMA’s new framework for collaboration with academia and the new EU Innovation Network.
Four key areas are highlighted by the plan:
1. Awareness of EMA’s SME initiative, with stepped-up engagement with pharmaceutical innovators, including incubators, universities and investors.
2. Training and education for SMEs and academia and expanding the EU Network Training Centre.
3. Support the development of new medicines by providing SMEs with regulatory tools to help develop treatments for unmet medical needs; aid academia and enhance cooperation on projects subject to EU funding.
4. Engagement with SMEs, EU partners and stakeholders to further develop the EU Innovation Network, EU initiatives supporting SMEs and start-ups in relation to funding, administrative burdens and interacting with international regulators.
EMA also on Wednesday published its SME office 2016 annual report, which features an overview of SME-related activities in 2016, and highlights incentives and platforms that SMEs can leverage to advance drug development and regulatory strategies.
Action plan for small and medium-sized enterprises
Tags: small- and medium-sized pharmaceutical companies, EMA on SMEs