n the 2026 Sir Alasdair Breckenridge Lecture, EMA Executive Director Emer Cooke set out her vision for fundamentally reimagining medicines regulation in response to accelerating scientific, technological, and societal change. Her central argument is focusing on changes for those who are at the interface between regulations and developer: the Regulators. In her view, Regulators must evolve from primarily being gatekeepers of medicines to becoming enablers of responsible innovation, while preserving the principles on which credible regulation depend: independence, scientific rigor, transparency, and trust.

EMA Executive Director Emer Cooke (courtesy of European Medicines Agency)

Cooke frames this challenge around a paradox: Biomedical science has never been more capable, yet significant patient needs remain unmet. mRNA vaccines, cell and gene therapies, personalized medicines, artificial intelligence, advanced manufacturing, and treatments for extremely small patient populations are impressive examples of the extraordinary pace of innovation. The question is therefore no longer whether science will innovatively advance, but whether regulatory frameworks can evolve quickly enough to translate that innovation into benefits for patients.

Medicines regulation needs adaptable individuals and communicators who can work on tasks across different domains and in multidisciplinary teams, whether regulatory, healthcare, or technology-based, and can collaborate with business. AI ethics, knowledge, and judgment become incredibly important skills in a future that is dominated by this technology.

Why the regulatory model must change

Much of today’s medicines regulation was designed for an era of small-molecule drugs, large-scale manufacturing, relatively predictable development pathways, and conventional clinical trials. Today’s environment includes gene editing, individualized cell therapies, platform technologies, decentralized manufacturing, device-drug combinations, digital twins, and AI-supported discovery and development.

For Cooke, incremental improvements to existing processes are insufficient. The “regulator of the future” must be as innovative and adaptable as the science it assesses. It must be able to deal with complexity, new technologies, and new approaches. And the outputs must remain anchored in the values that give regulation its legitimacy: independence, rigor, transparency, and trust.

COVID-19 demonstrated what is possible

Looking back through her tenure at EMA to date, Cooke finds that the COVID-19 pandemic provides the clearest evidence that regulatory systems can operate differently. EMA and Europe’s regulatory network mobilized more than 4,000 scientific experts, adapted working methods, intensified international cooperation, and evaluated vaccines and treatments at unprecedented speed.

Crucially, speed did not require abandoning regulatory standards. Instead, regulators collaborated more closely, worked in parallel rather than sequentially where appropriate, and concentrated resources on the issues that mattered most.

Cooke argues that this agility must become part of normal regulatory practice. Future infectious-disease outbreaks, antimicrobial resistance, medicine shortages, climate-related health threats, and geopolitical instability will demand regulatory systems that are adaptive, resilient, and capable of moving quickly without compromising standards.

Europe’s pharmaceutical reform

The proposed overhaul of EU pharmaceutical legislation represents, in Cooke’s view, the most important reform of European medicines regulation in a generation. It is intended to support the vision of a system that is faster, simpler, more flexible, and more supportive of innovation, while continuing to protect patients.

The reforms include simplifying EMA’s committee structure, reducing assessment times, embracing digitalization, and strengthening engagement with academia, biotechnology hubs, technology-transfer offices, start ups, and small and medium-sized companies.

Europe has been creating a more attractive environment for clinical research. Initiatives such as ACT EU and FAST-EU are underway to make clinical-trial assessment faster and more coordinated and facilitate innovative trial methodologies.

New tools will enable a new way of working: an EMA pilot to connect to tech transfer offices and biotech hubs across Europe. The sandbox concept will allow Regulators to learn and adapt safely together with Developers.

The objective is proportionality: AI as regulatory challenge

Regulators must simultaneously facilitate responsible AI innovation and safeguard the quality, safety, and efficacy of medicines developed or monitored using AI. Regulation that is too rigid may suppress useful innovation; regulation that is too weak may expose patients to unacceptable risks.

Cooke identifies three requirements to achieve this:

• Clear, predictable regulatory expectations across the medicines lifecycle;
• Robust governance from the beginning, including early agreement between developers and regulators on evidence requirements; and
• Deep international collaboration, with common principles emphasizing human-centered design, transparency, and multidisciplinary oversight.

Cooke’s vision of the ideal Regulator is one that understands which evidence genuinely matters and asks for neither too much nor too little.

One globally accepted single development plan for medicines

Future regulation should involve more joint scientific advice, collaborative assessments, reliance and recognition between regulators, and harmonized approaches to emerging technologies. Her long-term aspiration is particularly ambitious: a globally accepted single development plan for medicines.

International networks such as the International Coalition of Medicines Regulatory Authorities (ICMRA) remain an excellent model for a more integrated global regulatory ecosystem.

New technology requires new regulatory skills

Reimagining regulation also means reimagining the regulatory workforce. EMA is investing in digital skills, AI literacy, and stronger connections between data scientists and professionals with clinical and traditional regulatory expertise.

Future regulators will need multidisciplinary capabilities combining scientific judgment, data expertise, technological literacy, communication, and ethical awareness. Importantly, Cooke argues that greater reliance on AI will make human judgment more—not less—important.

Trust is ultimately the foundation

Cooke’s final—and perhaps most fundamental—theme is public trust. Regulatory reform cannot succeed through faster assessments, better data, or AI alone. In an environment of misinformation and declining confidence in institutions, regulators must communicate evidence clearly and with empathy, acknowledge uncertainty honestly, and engage people through channels they actually use.

EMA is therefore strengthening social listening, collaboration with trusted experts and stakeholders, multimedia communication, and efforts to counter misinformation and improve vaccine confidence.

Cooke’s ultimate vision is not simply a faster regulator. It is a learning regulatory system: agile Regulators, scientifically sophisticated, digitally capable, internationally connected, and responsive to patients, firmly anchored in independence, rigor, transparency, and public trust.

The full text of the lecture has been published on the EMA website.