The European Union is steadily losing its competitive edge in pharmaceutical innovation, trailing behind the United States and Japan. To reverse this trend, the European Medicines Agency (EMA) is pushing for a regulatory overhaul that prioritizes accessibility and expertise.
In an interview with Smart Health, EMA Director General Emer Cooke outlined the key challenges and potential solutions. “We need to make sure that we are transparent and accessible, especially for Small and Medium-sized Enterprises (SMEs),” she said. “Because SMEs are our superheroes. 20% of the products that we authorise in Europe are developed by SMEs. And they don't have the same resources to deal with the complexity of some of the regulatory processes.”
Simplifying the Pathway for Innovators
Cooke emphasized that the current regulatory framework, established by EU legislation, often overwhelms smaller players. “We have to think about simplification. We have to think about signposting. We have to think about, is it meaningful? Does it make sense? Is it accessible?” she asked.
The EMA is developing tools to help innovators navigate the approval process more smoothly. “We are trying to put in tools that help to make the pathways clearer. And also to make sure that innovators can navigate those pathways with our help,” Cooke explained.
This push for clarity comes as the EU seeks to foster a more dynamic pharmaceutical sector, one that can compete globally. The agency’s focus on SMEs is strategic: these companies often drive breakthrough therapies but lack the legal and regulatory teams of larger corporations.
Beyond procedural hurdles, Cooke highlighted a deeper issue: the need for updated expertise. “The other challenge we have is expertise. Because if we think about the medicines of the future, the lines between medicines, and technologies and medical devices are blurring all the time,” she said.
This convergence demands a new kind of regulator. “We need to make sure that we have a combination of scientific skills, technological skills and that we are not just thinking the way we thought 30 years ago,” Cooke added.
The EMA’s efforts align with broader European health policy trends. For instance, the UK Enacts Generational Tobacco Ban, Setting Precedent for European Health Policy, reflecting a continent-wide shift toward proactive public health measures. Similarly, innovations showcased at CES 2026 Showcases European Health Tech demonstrate the region’s potential in digital health.
To maintain relevance, the EU must also address regulatory fragmentation across its 27 member states. A harmonized approach, coupled with investment in training for regulators, could accelerate approval times and attract more research and development investment.
Cooke’s vision is clear: a more agile EMA that supports innovation without compromising safety. “We are trying to put in tools that help to make the pathways clearer,” she reiterated. For Europe’s pharmaceutical sector, the path forward lies in embracing change—both in regulation and in mindset.
