EMA and EISMEA partnership helps Europe’s health innovators accelerate the journey from discovery to patients

The agreement, signed by Emer Cook, Executive Director of EMA and Momchil Sabev, Director of EISMEA, will help companies better understand regulatory requirements earlier and prepare their technologies for successful development. 

This support is key as bringing a new medicine or medical technology to patients requires more than breakthrough science. Innovators also need to navigate complex regulatory pathways to ensure their solutions can be developed safely and effectively. 

Bridging the gap between discovery and patient impact 

The two organisations have been cooperating since 2021 on initiatives supporting innovation in the life sciences and health sectors. The strengthened cooperation will help innovative SMEs, start-ups, spin-offs, research organisations and universities navigate the path from scientific discovery to healthcare solutions that can benefit patients. 

Concretely, 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. 

‘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.’ 
– Emer Cooke, Executive Director, EMA 

‘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.’  
– Momchil Sabev, Director at EISMEA 

Building on a collaboration that’s already making a difference 

The impact of this cooperation is already visible. A recent survey revealed that three quarters of European Innovation Council (EIC)-funded innovators increased their awareness of EMA’s regulatory support tools thanks to joint EMA-EIC training activities.  

Respondents said EMA support tools had a positive impact on both product development and regulatory strategy, while 95% said they would use these tools again for future projects. 

Turning science into solutions 

EIC-backed company Ebenbuild, which develops digital twin technology for lung disease diagnosis and treatment, illustrates how innovators benefit from the EMA-EISMEA cooperation. 

Through the proactive portfolio management activities of EIC Programme Managers, the company was connected with EMA to better understand regulatory expectations and identify the most appropriate development pathway for its innovation. 

‘Ebenbuild has greatly benefited from early interactions with EMA. These exchanges helped to better understand the regulatory landscape and identify appropriate pathways for our innovation at an early stage.’ 
– Dr. Jonas Biehler, CTO and Co-Founder, Ebenbuild GmbH 

For health innovators, engaging with regulatory expertise early can reduce uncertainty, strengthen development strategies and help promising technologies progress towards patients. This is exactly what the EMA-EISMEA partnership is designed to enable.