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Singapore, 30 July 2026
Check against delivery (The published text is based on the prepared speech. Minor differences may have occurred during delivery)
Thank you, Prof. Lim, for that very generous introduction.
It is a great honour to deliver this lecture. Sir Alasdair was one of those rare individuals who managed to combine scientific excellence with public service. He understood that the regulation of medicines is more than just ensuring compliance with the rules. It must be about people, patients, and trust.
He ensured that innovation and scientific progress could be translated into tangible benefits for society. I am humbled to be speaking to you in his honour.
He had a vision. He pushed boundaries and opened minds. And I sometimes wonder what he might make of the changes we are experiencing in medicines regulation today, because these changes are profound.
We are living through an age of paradoxes, where everything is technically possible, but patient needs still go unmet. Never in human history have we been able to develop and roll out treatments as quickly as we can today. The science is here; the technologies are available. Scientific and technological progress is not the barrier.
During the COVID-19 pandemic, we saw mRNA and other vaccines move from scientific promise to global deployment in record time. Technologies that once seemed futuristic are now becoming routine. Cell and gene therapies are changing lives. We are looking at how to approve medicines with for very small patient populations, sometimes only one patient. Artificial intelligence is accelerating discovery. Advanced manufacturing is reshaping production.
And yet, despite all this progress, we must recognise that we could still do better for patients and help them get the medicines they need faster. This paradox sits at the heart of modern healthcare. It is also why we are here today. Because the question before us is not whether innovation will continue. It will. The question is whether our institutions can evolve quickly enough to ensure that this innovation reaches patients.
For medicines regulators, this means embracing a slightly different identity. Historically, we were often viewed as gatekeepers. Our job was to say ‘yes’ or ‘no’. Today, while safety, efficacy and quality remain non-negotiable, we increasingly see ourselves as enablers of innovation. Our role is to help science reach patients while maintaining public trust.
That requires something more profound than reform. It requires reimagining.
It is not about improving existing processes around the edges, but it poses a much bigger question: what must a medicines regulator become to be fit for purpose in our current world? That is the question I want to explore with you today.
The regulator of the future must be every bit as innovative as the science it is asked to assess. It must be able to deal with complexity, new technologies, new approaches. And the outputs must remain anchored in the values that give regulation its legitimacy: independence, rigour, transparency and trust.
Now let’s discuss the case for change. The first reason we need change is simple. The rules that govern much of medicines regulation were written for a different era. I had the privilege of contributing to the development of some of that legislation in Europe. Those regulatory frameworks were groundbreaking at the time, and they served us well.
But they were designed for a world where medicines were largely small molecules, manufactured at scale, developed in predictable pathways, and evaluated through relatively conventional clinical programmes. Today, we face a completely different landscape.
Just think about the amount of innovation in the medicines pipeline, from gene editing to personalised medicines, from cell therapies manufactured for individual patients to platform technologies. Earlier this month, for example, we recommended an ocular implant which gradually releases a medicine to treat several types of eye diseases. The only alternative for patients, until now, was to receive frequent injections in the eye.
We have AI systems capable of identifying drug candidates, analysing data and supporting clinical development. We even have AI companies trying their hand at developing new treatments for rare diseases from scratch.
The game has changed. And when it does, the rulebook needs to evolve too.
The great thing is we have already shown that we can adapt quickly to support innovation. The COVID-19 pandemic required that of us all. It tested every institution: regulators, governments, healthcare systems. And it taught us something important: in crisis mode and when we work together, we can move much faster than we thought possible. Europe’s greatest strengths lie in its people and its expertise: more than 50 national competent authorities, 27 Member States and 24 official languages working together for a population of around 450 million people.
During those years, we were able to mobilise our network of more than 4,000 scientists. We were able to intensify our scientific activities, adapt and enhance our transparency work, and approve new vaccines and medicines, as well as to issue advice and recommendations, all at unprecedented speed, so that European citizens could benefit. We were able to think outside of the box, introduce new ways of working, focus on what really mattered.
International cooperation also reached unprecedented levels. We met at least weekly as an international community. We held workshops to figure out what was needed, what we could do together. We were able to allow parallel rather than sequential nonclinical and clinical development. We incorporated international regulators in our review processes. We discovered that urgency can be a powerful catalyst for innovation. The challenge now is to preserve that agility in the new normal.
Because we know future shocks are coming. What was once seen as a crisis is becoming the new reality. Since COVID, we’ve seen mpox outbreaks, hantavirus outbreaks, Ebola outbreaks, and medicine shortages. We can expect new infectious disease challenges, impacts from antimicrobial resistance and climate-related health effects.
We also live in a time marked by geopolitical instability and conflicts. This might also be the new norm, with the future marked by greater uncertainty, not less. All these emerging challenges mean that regulators must become more adaptive. More responsive. More agile. We need to move faster, but without compromising standards. Because in our line of work, what is at stake is human life.
In Europe, we have recognised that we needed to be more attuned to where innovation is happening and we need to move from a reactive to proactive model of regulation... from a system that waits for innovation to arrive, to one that helps shape the conditions in which responsible innovation can succeed. The task for us all is not to choose between speed and safety. It is to design systems that deliver both: faster pathways for promising innovation, and stronger safeguards for the people who depend on us.
We need a more agile regulatory system. We need to use the power of data to enable better evidence generation, whether from randomised clinical trials or from real world sources. Our system needs to be capable of adapting as science evolves, supporting emerging technologies before they become mainstream, and engaging developers early rather than only at the final stages of development. We need to enable innovation to flourish, rather than constraining it.
The proposed revision of the EU pharmaceutical framework represents the most significant reform of medicines regulation in a generation. It has a clear purpose: to create a system that is faster, more flexible and more supportive of innovation while continuing to protect patients. We see it as a game changer, but what exactly is changing?
We are moving from complexity to simplification. We are simplifying the make-up and number of our human medicines committees. Reducing assessment times, cutting the time it takes to get approvals, embracing digitalisation. These are not minor administrative tweaks - they represent a fundamental shift toward reducing unnecessary burden while focusing our collective resources on what truly matters: scientific excellence based on the best evidence and patient safety.
We are increasing our engagement and proximity to innovators: academia, biotech hubs, technology-transfer offices, start-ups and small and medium enterprises. We are embracing patient experience data, making better use of real-world evidence. Our engagement with biotech clusters and technology-transfer offices is intended to make regulatory support more accessible, more practical and easier to understand, especially for innovators who may be encountering the regulatory system for the first time. This connection and early dialogue matters. Our stakeholders need us to deliver on this.
And then, of course, clinical trials. We all want to enable the clinical trials that drive medicines innovation. In Europe we need to take more advantage of our population of 450 million people to drive European and global research to new heights. We have initiatives to accelerate the delivery of larger clinical trials underway (ACT EU and FAST-EU) where we are testing ways to make clinical trial assessment faster and more coordinated and to enable innovative methods such as adaptive approaches, platform trials, decentralised trials.
What are some of the new tools at our disposal? We are exploring new mechanisms to position regulators as genuine partners in innovation. We launched a pilot to work better with tech transfer offices and biotech hubs across Europe. We are going to where innovation is happening. Not waiting for it to come to us. We are helping smaller innovators to make connections with funders and investment bodies. Access to capital is one of the key barriers to enabling innovation.
Regulatory sandboxes are another example. These environments allow innovators and regulators to work together in controlled settings to understand emerging technologies and develop appropriate oversight. What I love about the sandbox concept is the ability to learn and adapt. We can use them to learn safely, together.
They provide a structured and supervised space for regulators and developers to explore innovations that do not fit neatly into existing frameworks, including personalised medicines, platform technologies, decentralised manufacturing, digital twins and other AI-enabled approaches.
Artificial intelligence is perhaps the clearest example of this shift in our role: AI creates a dual responsibility for us. We must be facilitators, helping responsible AI innovation reach patients. But we must also remain gatekeepers, ensuring that any medicine developed, manufactured, monitored or supported by AI still meets the same standards of quality, safety and efficacy.
I believe that there are three things that need to be in place to ensure that AI-driven innovation reaches patients.
These 10 principles provide guidance on the use of AI in evidence generation and monitoring, from early research and clinical trials through to manufacturing and pharmacovigilance.
The challenge is to strike the right balance: regulation that is too rigid can hold back promising innovation, but under regulation can expose patients and society to unacceptable risks. Our task is to find the middle ground where innovation can thrive, while safety, quality and public confidence remain protected.
That balancing act has always been part of the art of regulation. Today it is becoming even more important. It is always tempting to ask for more, but the best regulator, my future regulator, understands what really matters and gets it just right, like Goldilocks. Using the power of that better data to ask and get answers to the right questions.
Equally important is the evolving model of international collaboration. I’ve spent many years talking about the ‘six Cs’ as the basis for good international regulation. Communication, cooperation, coordination, collaboration, convergence and coalitions.
In our increasingly interconnected world, we need to move away from working in silos or within our geographies. The future is characterised by closer cross-agency collaboration and harmonisation, joint scientific advice, collaborative assessment pathways, greater reliance and recognition, and looking at innovation collectively. My dream of a globally accepted single development plan will become reality.
More connected, more integrated and more global. These are things Sir Alasdair championed during his career. We need to think not just about what the future of medicines regulation looks like, but how we bring our partners and stakeholders with us on the journey. My tenure has convinced me of the strength of global partnerships. A lesson of the past and a learning for the future is that we are always stronger when we work together.
It is really the DNA of our regulatory network. And I think if we reimagine the networks we create as medicines regulators, a future reimagined must be more connected (not less), more integrated and more dynamic than it is today. They will be larger networks to reflect the complex, dynamic production ecosystem that is steered by data-generated decisions.... as medicines development becomes more automated.
I have always maintained that a network such as ICMRA, which came into its own during the COVID pandemic, is an excellent model of this type of collaboration. We can go further as a global community.
Reimagining medicines regulation for an uncertain future has implications for our most valuable resource: our people. I am now entering the final stretch of my time as executive director of EMA. In this role I am responsible for more than 1000 people. Medical doctors, pharmacists, veterinarians, data analysts, business analysts, scientists, communications professionals, data scientists and administrators. We have people like me, who have been around for a long time and new graduates who see the world very differently. We must make the most of our respective strengths.
With AI disrupting our work, a reimagined medicines regulator includes reimagined roles and reimagined functions. Our regulatory network consists of different people with different skills, and this is valuable, but we also need the skills of tomorrow. The sheer speed of innovation requires us to interpret where the digital expertise is required and the right mix of skills we need for today and for tomorrow. At EMA, we are focusing on digital upskilling, AI literacy and investing in training and development, knowing that combinations of skills will be important. We are urgently considering how to support our staff and build bridges between skillsets (those with more data skills and those with more regulatory or clinical skills).
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 judgement become incredibly important skills in a future that is dominated by this technology.
We are also thinking more broadly about the scientist’s role in a system where digital change is ubiquitous and where resources are tight. The future regulator, reimagined, will build on the foundations we are putting in place today. The legislative reforms, digital tools and collaborative models we are developing are not ends in themselves. They are enablers of a system that is faster, smarter, more resilient and more responsive to patients' needs.
Getting to the point where we realise our ambition will require guts and clarity of purpose. And good communication. Now more than ever, we must explain the evidence clearly, communicate uncertainty honestly and help people understand not only what we do, but why it matters. Which brings me to the role that transparency and communication must play.
We need to navigate a world in which fewer people believe in us. We are effectively playing a new game, a game of non-believers.
People who trust scientific findings are more likely to follow health guidance, adopt new technologies, and support policy recommendations. However, trust is eroding in front of our eyes. Coupled with the current geopolitical situation, there is a pressing need for medicines regulators to be 'out there’, fill the gap left by others and speak up for science, evidence-based medicine regulation and international collaboration as hallmarks of our way of working.
And we need to think about new ways of working, if we want to remain trusted and relevant, we must evolve. We must communicate not only with scientific rigour, but with empathy, clarity and timeliness. Meeting people where they are, not where we wish they were.
Let me share some of our ideas on rebuilding trust. We need to activate content locally: working with networks of experts and stakeholders, content creators, and national media. We need a wider range of tools to connect, especially with younger generations: for example, through podcasts, media seminars and more innovative uses of multimedia. We have started our own podcast series, Inside EMA, to showcase our experts and the incredible work that they do to protect public health.
We have developed a framework to address misinformation. It relies on three core pillars:
Better collection of insights: To drive management of misinformation EMA has developed a listening process, similar to infodemic management: a proactive approach that addresses misinformation, misconceptions, concerns, communication voids, building on learnings and guidance from other public health institutions.
Overall, we're aiming to make best use of all the data available to EMA through social listening, collecting queries from media/public, direct engagement with stakeholders… to identify trends, and gather intelligence on misinformation issues, to act more effectively.
Collaboration: We are working with regulatory partners, stakeholders and experts in infodemic management, to join forces, share best practice and expertise. We are activating our allies: people will not believe that a piece of information is false only because an institution says it; they trust it is false because other credible voices say the same.
We are also standing up for science and trust in science through our communications activities. We are diversifying our reach on social media: since individuals tend to be more trusted than institutions, we are empowering EMA colleagues to be effective ambassadors of EMA’s public health actions and relay scientific facts in areas of misinformation. We provide accurate and science-based information in areas of misinformation and misconceptions.
Above all, this is about earning and maintaining trust. If I look into the future, a reimagined medicines regulator won’t be simply about a faster or more efficient system. It will be a learning system that earns trust and remains worthy of the public confidence on which medicines regulation, and public health, ultimately depend.
And I believe one of the people who best understood this is Sir Alasdair. He would have recognised the importance of this challenge. And I hope he would have approved of everything we are doing today, and our great ambition, to meet it.
Thank you so much for the honour of inviting me to talk to you today.