Not Just Operating Within Our Own Lane: European Medicines Agency’s Role Expands Across Drug Development Life Cycle
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Interview with Emer Cooke, MBA, Executive Director, European Medicines Agency
As the European Medicines Agency (EMA) navigates the most significant expansion of its mandate in a generation, Executive Director Emer Cooke highlights how the regulator is further strengthening its role across the full life cycle of medicines. Cooke sets out how EMA is enhancing its engagement—from early developer support and clinical trial reform to artificial intelligence governance and the emerging health technology assessment interface—and why she believes the conditions for a step-change in European competitiveness have rarely been better aligned.
“ I often say that you can be the best regulator in the world, but if the products don’t reach the patient, they have no value.”— Emer Cooke
PharmaBoardroom: With the European Union (EU) pharmaceutical legislation now agreed and the EMA’s extended mandate fully operational, Europe is asking far more of its regulator than it did a decade ago. Has the EMA’s DNA changed to reflect that broader role?
Emer Cooke: I started as executive director in November 2020, right in the middle of the COVID-19 pandemic, which was a real wake-up call in terms of the importance of working collaboratively. That lesson is still shaping our work and outlook today, especially in the context of the new EU pharma legislation, health technology assessment (HTA) regulation, and the EMA’s extended mandate.
Even if our core mission as a medicines regulator remains unchanged, we are increasingly focused on making that work matter more for European patients. I often say that you can be the best regulator in the world, but if the products don’t reach the patient, they have no value. We have to think not only about what we do, but about how our scientific work is perceived, how it is translated into the work of other bodies, and what it ultimately takes to get to the patients.
PB: The new EU pharmaceutical framework gives much greater weight to unmet medical need in determining incentives for innovation. How are you working to standardize that definition and ensure sufficient predictability for developers?
EC: It is important to realize that the concept of unmet medical need already exists across various pieces of legislation—in our conditional marketing authorizations, in the orphan regulation—and we already use it to determine regulatory pathways. But it is a difficult concept, because one person’s unmet need is not necessarily another’s.
The new legislation requires us to produce a guideline on the application of the criteria for unmet medical need, and, critically, we are required to consult with payers and HTA bodies on this guidance development. That has not been the case before. It gives us the opportunity to look at unmet medical need from a wider perspective but also places a responsibility on EMA to ensure that our understanding better aligns with that of other stakeholders—including patients, whose conception of unmet need can be very different from that of health systems.
The challenge, in the context of the new legislation, is to find the right balance: one that provides sufficient certainty for developers, while giving downstream decision makers a voice in the criteria for identifying an unmet medical need.
PB: In 2024, your colleague Peter Arlett told us that while European clinical trial numbers were stable at around 300 per month, they were not growing at the same pace as in the United States or China. He described ACT EU as a potential game changer. Two years on, where do things stand?
EC: ACT [Accelerating Clinical Trials] EU is a broad initiative, established in 2022, that aims to accelerate and streamline clinical trials across the EU. It is a joint effort between the EMA, the European Commission, and the Heads of Medicines Agencies and was born out of a recognition that concerted action on clinical trials in Europe was needed. The Clinical Trials Regulation had not yet come into full operation, fragmentation was increasing, and Europe was losing ground as a destination for trials.
The challenge is to find the right balance: one that provides sufficient certainty for developers, while giving downstream decision makers a voice in the criteria for identifying an unmet medical need.
ACT EU addresses this by focusing on several priority areas. We have established a multistakeholder platform to help set those priorities and are working across 8 different workstreams. One covers clinical trials in public health emergencies and the acceleration of the clinical trial approval process, which could include having a standard protocol ready to deploy by sponsors—rather than starting from scratch each time a crisis emerges. Another looks at the landscape of scientific advice offerings across Europe: how they can work better together and where there is a case for streamlining. We also have a dedicated workstream on methodological innovation in clinical trial design and conduct.
Two other developments are worth highlighting. First, ethics committees have been brought into the ACT EU framework, recognizing the essential link between ethics approval and clinical trial authorization. Second, we collaborate closely with the COMBINE initiative, which brings together efforts on clinical trials for medicines and medical devices—an area that has historically operated in silos.
PB: With so much already underway, what are the key remaining objectives for the EMA, particularly around speed and simplicity for developers?
EC: There are a few things I would add. One is transparency. We now have an interactive clinical trial map where you can click on any part of Europe and see which trials are running, in which therapeutic areas and diseases, which are recruiting, and which are in progress. That is available across all EU languages, and it is a genuinely useful tool for patients and doctors to navigate the clinical trial landscape and, importantly, to find suitable trials.
Perhaps the most concrete initiative to highlight here is FAST-EU [Facilitating and Accelerating Strategic Clinical Trials in the EU], a pilot project run with EU member states that aims to bring the current average assessment time down from 106 days to 70 days. The results so far are encouraging: 83 expressions of interest and 17 clinical trials accepted for accelerated assessment across 15 different member states and with 18 different sponsors. Three have already been completed—all within the FAST-EU timeline.
One of the more significant shifts in the last 2 years has been an initiative whereby we reach out to developers rather than waiting for them to come to us.
What makes this particularly meaningful is that participation was voluntary. Member states that signed up had to commit to delivering on that timeline and had to bring their ethics committees along with them. That kind of institutional buy-in is not easy to secure, and the fact that it is working is impressive.
PB: Life sciences venture capital in Europe now represents just 7% of the global market, and many biotechs continue to look outside Europe for funding and IPOs. Is there a role for the EMA in making Europe more attractive in that regard?
EC: This is something we are very much aware of, and it connects directly to the question of whether we are more than a medicines regulator and can also be an active contributor to innovation and competitiveness.
We already offer scientific advice to academic sponsors and small and medium-sized enterprises (SMEs), and there are specific regulatory incentives in place for SMEs. Companies can come to our Innovation Task Force to discuss regulatory challenges early, which also helps us build the expertise we may need at a European level.
But one of the more significant shifts in the last 2 years has been an initiative whereby we reach out to developers rather than waiting for them to come to us. What we were finding was that many early stage developers simply were not aware of the regulatory requirements, which meant they risked failing in delivery of medicinal products not because of the science, but because they had not addressed the regulatory dimension.
But it is not only about awareness. It is also about connectivity—helping developers understand where European funding is available and making the right introductions. Increasingly we see our role is about bringing partners together across the lifecycle, not just operating within our own lane.
We also have an innovation network spanning all member states, with innovation offices in each country that know the national funding landscape. The support structure already exists at both the European and member state levels; the challenge now is making sure developers know how to access it.
PB: At the same time as faster approval pathways are being pursued, HTA bodies are now demanding more robust comparative evidence. How do you manage those potentially competing pressures?
EC: I would push back slightly on the idea that what HTA bodies are asking for today is inherently more robust than what we look at during marketing authorization evaluations. I would say it is different.
That said, the real challenge is achieving a shared understanding of what evidence is needed for regulatory purposes versus what is needed for HTA. This is work we have been doing since 2010, even before the HTA Regulation was adopted.
But the regulation is still in early rollout. We currently have 5 products that have received a positive opinion from our human medicines committee and are in scope of the Joint Clinical Assessment process, with the first one completed in April [editor’s note: 2 more products completed the process in July]. It is a fantastic achievement seeing these parallel, European-level reviews of clinical data progressing. This work is certainly a catalyst for supporting the introduction of innovative medicines into healthcare systems. And at the same time, the transparency of these assessments provides the insights that show there is still significant work to do on aligning approaches to evidence between the regulatory and HTA sides and for developers to generate a holistic evidence plan.
It is a fantastic achievement seeing these parallel, European-level reviews of clinical data progressing. This work is certainly a catalyst for supporting the introduction of innovative medicines into healthcare systems.
One encouraging sign from this collaboration is that HTA bodies have developed a much greater appreciation of just how rigorous the regulatory process is. That shared understanding matters. But we cannot require a full comparative assessment for every innovative product. For medicines in situations where there are few available treatments, or where the standard of care differs across member states, that simply is not feasible—and we have a responsibility to patients that means we cannot always wait. The answer lies in greater use of the tools available to us: real-world evidence, additional follow-up studies, registries. These are some of the means by which we can build confidence in new products over time.
PB: You have spoken recently about artificial intelligence (AI) and data being the backbone of trustworthy medicines regulation. What progress is the EMA making, and where do you see AI having the greatest impact?
EC: AI is part of everyone’s work these days, whether they know it or not. For us at the EMA, this technology’s impact falls into 3 broad areas.
The first is understanding how AI is being used in medicines development itself: screening for new medicines, accelerating clinical trials, preparing regulatory dossiers. The industry is already using these tools extensively, and we need to understand how, in order to regulate them properly.
The second is using AI to make ourselves more efficient: managing pharmacovigilance data, handling large datasets, embracing digitalization more broadly. There is significant work underway in this space.
The third covers our operational processes: social media monitoring, literature surveillance, managing invented names (where AI can flag similarities with existing names and help prevent medication errors), and more generally freeing our staff from routine procedural tasks so they can focus on critical thinking.
Across all 3 areas, trustworthiness is the central concern. We have rolled out an AI literacy program for all staff, we are developing common approaches across the European network of regulatory agencies, and we are fully compliant with the AI Act. We have a risk assessment process that every new tool must go through before it is deployed, and keeping the human in the loop is something we are very deliberate about.
On the international side, we have published good AI principles for medicines regulation jointly with the US Food and Drug Administration, with the aim of extending these to the broader international community.
PB: Finally, what gives you cause for optimism about Europe’s future in medicines regulation?
EC: Honestly, I think the future is now, and the stars are aligned for a brighter future. There is a huge opportunity to enable innovation and improve competitiveness in Europe. We have done the thinking. Now is the time to put it into practice.
