Europe is testing plenty of new medicines—but mostly at the later stages. The earliest, most experimental studies, where drugs are first tried in humans, remain surprisingly scarce. According to Dr Peter Arlett of the European Medicines Agency (EMA), this imbalance could shape the future of medical innovation in the EU.
“In terms of being the hub of R&D for the pharmaceutical industry,” Dr Arlett said at a recent Clinical Trials Forum by the Belgian pharmaceutical industry, “we want to be attracting early phase I clinical trials, because often then the investment stays in that country or region.”
The issue isn’t just about numbers. The earliest trials—so-called phase 1 studies—often determine where the rest of a drug’s development takes place. They shape where larger studies are run, where scientific know-how builds up, and where long-term investment ultimately settles.
Phase 1 trials accounted for nearly 40 per cent of all new drugs studied in China.
Industry data echo the concern. Earlier analysis published by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and IQVIA shows that Europe has seen a particular decline in the proportion of phase 1 trials. This raises concerns about weakening the pipeline of future studies.
China’s early-phase boom
The contrast with China is increasingly difficult to ignore. According to China’s 2024 Annual Report on the Progress of Clinical Trials for New Drug Registration, phase I trials accounted for nearly 40 per cent of all new drug studies and almost half of innovative drug trials. Early-stage activity was particularly pronounced in cell and gene therapies and radiopharmaceuticals. In addition, phase I studies represented close to three-quarters of completed trials, reflecting both speed and throughput.
Multinational investment patterns reinforce the trend. Last week, pharma company AstraZeneca committed $15bn to expanding its China operations through 2030. The investment spans early research, clinical development and manufacturing.
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The company operates global strategic R&D centres in Beijing and Shanghai that collaborate with more than 500 clinical hospitals and have led a large number of global clinical trials over the past three years.
McKinsey’s assessment of China’s clinical research boom points less to trial volume than to execution. The consultancy argues that China has compressed the path from discovery to first-in-human studies by 50–70 per cent compared with global averages. This is driven by parallelised workflows, dense CRO ecosystems and a culture of executional intensity.
The world has not stood still over the past year and neither has Europe’s clinical trials ecosystem. – Katarina Nedog, Director Regulatory Policy, EFPIA
Rather than a single policy lever, McKinsey frames China’s rise as an ecosystem effect. Large hospital networks, regulatory speed, Contract Research Organisation (CRO) and Contract Development Organisation (CDMO) density combine to let programmes start quickly, and then stay.
Three lanes, one direction
The difficulty lies in timing: Europe is reforming its clinical trials system while global competition continues to accelerate.
“The world has not stood still over the past year,” Katarina Nedog, Director Regulatory Policy, said at the Clinical Trials Forum. “And neither has Europe’s clinical trials ecosystem.”
Her message was that progress is now happening on three fronts at once. And failure in any one of them risks undermining the rest.
One track is structural. The proposed Biotech Act, alongside targeted changes to European rules on in vitro diagnostic medical devices (IVDR) and European medical devices regulation (MDR), is meant to reset the framework for the next decade.
The goal is a system that is more predictable and proportionate, with shorter and more harmonised timelines, stronger coordination through the reporting member state, less duplication via a core dossier model and a single pathway for combined drug, device and diagnostics studies.
A second track is experimental. With legislation still moving, initiatives such as FAST-EU and COMBINE are being used to test whether faster, more coordinated regulatory pathways can work in practice. Particularly for multinational and complex trials, within the current rules. The point, Mrs Nedog argued, is not just to pilot new processes, but to generate evidence before the law catches up.
Some people say it’s not ambitious enough. Others say, what if we don’t reach those figures? – Dr. Peter Arlett, European Medicines Agency
The third track is immediate delivery. Under the existing Clinical Trials Regulation, EFPIA’s own data show a mixed picture: mono-national trials can move quickly. But multinational and innovative studies still run into delays, administrative burden and operational inconsistency.
Europe cannot, Nedog warned, afford to compensate for weakness in one area with progress in another. “We cannot outperform in one and then compensate for the lack of success in any of the other,” she said. Competitiveness, depends on all three moving together, now.
Ambition in numbers
Above all three lanes sit the numbers regulators have now attached to success. The European medicines network has set two headline targets. An additional 500 multinational clinical trials by 2030, and two-thirds of studies starting recruitment within 200 days of application.
Dr Arlett acknowledged the unease those benchmarks have provoked. “Some people say it’s not ambitious enough,” he said. “Others say, what if we don’t reach those figures?’”
Industry: speed
The same point resurfaced days later in a different setting. At a discussion of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) on trade pressures and investment decisions, industry executives again returned to the constraint shaping Europe’s competitiveness in clinical trials: execution speed.
For Italian pharma company Menarini, the priority remains unmistakable. “Reforming the clinical trial regulation for all products, and making sure that that process is a lot more streamlined, and can catch up with other regions that are going at lightning speed, like China, that is number one, is key,” said Emanuele Degortes, Head of Government Affairs and Patient Advocacy.
Others stressed that progress does not hinge on reopening legislation. Speaking for EUCOPE, Alexander Natz, Secretary General, pointed instead to operational drag within the existing framework. “We don’t always have to change our legislation,” he said. Mr Natz argued that administrative burden and system performance now matter more than new rules.
Asked whether the current reform window would be sufficient, Mr Natz answered. “At the moment, that is the best shot we’ve got. So we need to make the most of it and not lose that opportunity.”
The question of whether Europe can turn regulatory stability into (early-phase) delivery will soon move from conference rooms to ministerial tables.
On 26 February, EU health ministers will convene in Lefkosia, Cyprus, for an informal EPSCO meeting, where one session will focus on the idea of a European Centre of Clinical Excellence for Pharmaceuticals. Chaired by Cyprus health minister Neophytos Charalambides, the discussion will test whether Europe is ready to translate ambition on clinical trials into coordinated political action.
