The European Medicines Agency (EMA) and the European Innovation Council and SMEs Executive Agency (EISMEA) have signed a Letter of Intent to reinforce cooperation in support of Europe’s health innovators.
The agreement, signed by Emer Cook, Executive Director of the EMA, and Momchil Sabev, Director of EISMEA, aims to help companies better understand regulatory requirements earlier and prepare their technologies for successful development. The partnership will assist SMEs, start-ups, spin-offs, research organisations and universities in navigating the path from scientific discovery to healthcare solutions.
The cooperation will include advice, guidance, training and engagement with the wider research community. The partnership will also support horizon scanning, helping both organisations identify emerging health technologies and better understand the opportunities and challenges they may bring.
EMA Executive Director, Emer Cooke, said: “Innovation plays a central role in Europe’s medicines ecosystem ─ and EMA recognises both the opportunities and the challenges contributors face in navigating complex development pathways. Supporting innovators through our collaboration with EISMEA is one of our key initiatives to help tackle unmet medical needs, advance health outcomes and strengthen Europe’s competitiveness.”
EISMEA Director, Momchil Sabev, added: “The earlier health innovators can engage with regulatory expertise, the better equipped they are to make informed development decisions, reduce risk and achieve our shared objective: to get innovative solutions to patients. This partnership is another step in creating the conditions that allow Europe’s most promising companies to succeed.”
The partnership is the latest in a number of initiatives by the EMA to support the development of breakthrough medical devices in the EU. Earlier this year, the organisation launched a pilot programme to test a new regulatory pathway that supports patient access to highly innovative technologies, while maintaining the EU’s rigorous safety and performance standards. As part of the pilot, manufacturers whose devices are granted ‘breakthrough’ status benefit from enhanced regulatory support, including priority scientific advice from the medical device expert panels that are overseen by the EMA.
Breakthrough designation can be granted to highly innovative medical devices that demonstrate the potential to address unmet medical needs, or that offer substantial advantages over existing technologies. As part of the pilot, manufacturers seeking breakthrough designation can submit a request to the medical device expert panels. The subsequent assessment considers, among other aspects, the degree of innovation and the potential to address unmet medical needs or provide significant clinical benefit compared with existing alternatives.
The EMA pilot is being conducted in three phases. Phase one is open to class III (high risk) medical devices and class IIb active medical devices intended to administer or remove medicines from the body. Detailed guidance and application templates for manufacturers for phase one are published on the EMA’s website. Subsequent phases of the pilot will be open to other types of devices, including in vitro diagnostics (IVDs).
