If you are a new biotech company with $30–50 million burning a hole in your back pocket, the most important country in the world is not necessarily the one in which you are likely to make the most money (one day). More likely it will be where you can recruit that all important first participant into your trial fastest and start generating credible human data.
Drug development is brutally time-sensitive. Faster development reduces capitalised development costs and, perhaps more importantly for a small biotech, accelerates you to the point where a programme can be partnered, financed or killed. Modelling has shown that reducing development time has a substantial impact on the economics of R&D [1]. Meanwhile, site selection is strongly influenced by site capability, data quality and the ability to get participants enrolled quickly [2][3]. This makes time to first patient a useful, if imperfect, measure of national competitiveness. And the USA has noticed.
The FDA has recognised a problem
The FDA’s 2026 programme to accelerate and modernise clinical development is unusually explicit about the need to improve the US position. Its initiatives span the development pathway, from Phase 1 IND preparation through to pivotal trials and evidence generation [4].
The early-development measures are particularly interesting. The FDA has introduced a Phase 1 IND Navigator, clarified phase-appropriate CMC expectations, established a Phase 1 contact mechanism and proposed an Expedited IND model involving Qualified Research Institutions, rolling submission of IND components and more iterative interaction with sponsors. The agency says that, in appropriate circumstances, its revised Phase 1 CMC approach could save 6–12 months of development time. Clearly, this is the FDA’s guestimate, not an independently confirmed metric, and it should therefore be treated as such [4].
The FDA is also pursuing New Approach Methodologies, including computational and human-relevant approaches. It is also reconsidering just how much information needs to be provided for each stage of development. In late-stage development, it is revising its approach to substantial evidence, master protocols and innovative trial designs [4].
Perhaps most radical is the move towards real-time clinical trials. In April 2026 the FDA reported proof-of-concept studies in which selected trial endpoints and data signals were being transmitted to the agency as trials progressed. A proposed pilot was intended to explore whether AI-enabled technologies could improve early-phase decision-making [5][6].
It’s clear that this is more than an attempt to shave a few days from a regulatory clock. If successful, it could markedly alter the architecture of drug development, reducing the white space between development stages. But this raises the question: Is the FDA actually the bottleneck?
A clinical trial does not begin when a regulator says yes. It is a multi-step journey that involved:
candidate → preclinical development → IND/CTA → regulatory review → ethics → contracts → site selection → site activation → recruitment → first patient → useful clinical data.
Every step has the potential for delay. Global trial start-up data identifies regulatory processes, budgets and contracts, insurance, supplies, site selection, site activation and inefficient contracting and onboarding processes as major contributors to delay [7]. Benchmarking of 105 global trials observed that the early stages of site initiation accounted for much of the cycle time, noting substantial variations between regions and site types [8].
This matters enormously. A faster FDA cannot, by itself, make an American hospital negotiate a contract faster, activate a research pharmacy sooner, recruit eligible participants more effectively or provide an investigator with greater capacity. In other words, the FDA controls the gate, it does not control the path. That distinction is central to America’s competitive problem.
The Australian fast lane
Australia has successfully marketed itself as first choice for early clinical development because its regulatory architecture is designed to get studies moving with lower regulatory burden than required by other major regions.
The Therapeutic Goods Administration operates the Clinical Trial Notification and Clinical Trial Approval pathways, with ethics review and institutional authorisation forming important parts of the system [9]. Australia is now attempting to go further through the National One Stop Shop, designed to replace fragmented state and territory processes with a national platform that would reduce duplication [10]. This is important because Australia is not standing still while the rest of the risk-averse world, including the FDA, considers their options.
Its advantage is not simply regulatory speed. It has involved the rapid recruitment of early-phase investigators, opening specialist centres, and establishing clinical-trial industry, mimicking traditional systems familiar to international sponsors. Discussions with one site indicated how their unit had grown from 2 to 300 people in less than 3 years. There are obvious limitations. Australia’s population is small compared with the US, Europe or China, and that can become important when recruitment requirements expand. The same site reported a recruitment team of over 90 people compared with 5 or 6 for most UK/EU units, implying recruitment issues. Geographic distance and state-level governance have also historically created friction. But for a small biotech asking a very simple question, those limitations can be glossed over and may not matter initially.
China: not just another regulator
China presents a different challenge. Its competitive proposition increasingly combines regulatory reform with scale, infrastructure, domestic biotech capability, CRO capacity, government investment and a huge patient population [11][12]. The most important change may therefore be structural rather than regulatory.
A 2026 JAMA analysis found that the US share of global early-stage biopharmaceutical development programmes fell from 48.2% in 2015 to 37.4% in 2024, while China’s share rose from 8.0% to 32.3% [13]. That represents a striking shift, although it is not definitive evidence that China is universally faster or better at clinical development. Definitions and data matter, and domestic Chinese development activity is a major component of the increase.
Nevertheless, the strategic implication is difficult to ignore. America is not competing with the Chinese regulator alone. It is competing with an increasingly integrated biotechnology ecosystem. Chinese CROs have become important intermediaries connecting domestic R&D capability with global pharmaceutical development [11]. Chinese companies are also increasingly licensing innovative assets internationally, reflecting a shift from a predominantly ‘bring-in’ model towards ‘go-global’ development [12].
There remain obvious constraints, including geopolitical risk, intellectual-property concerns, international data considerations and delicate relationships between China and Western pharmaceutical companies. But China’s advantage is potentially its ability to combine speed, scale and industrial capability.
Europe: trying to fix the fragmentation problem
Europe has traditionally had a different problem. Its enormous potential clinical population, strong academic medicine and sophisticated pharmaceutical industry have been offset by what was seen as fragmentation between countries, regulators, ethics systems and healthcare organisations [14]. The Clinical Trials Regulation and CTIS were intended to address some of this fragmentation.
There are questions over the lost value from the homogenisation [14], and the transition has not been painless. Early experience identified document burden, technical problems and continuing complexity, although there was also evidence of improved approval timelines compared with previous arrangements [15]. More importantly, Europe is now at least measuring the problem.
The EU’s 2030 targets include 500 additional multinational authorised clinical trials and a goal of two-thirds of trials beginning recruitment within 200 days of application. By the end of June 2026, 84 additional multinational trials had been authorised and 40.8% of trials were recruiting within 200 days [16]. ACT EU’s 2026–2027 workplan continues the process, with an emphasis on implementation of the Clinical Trials Regulation, clinical-trial analytics, multinational trials, patient involvement and reducing administrative burden [17].
It is clear that Europe is offering an interesting counterpoint to USA. The EU is not claiming that its system is fixed, but it is attempting to measure, manage and improve it.
The UK experiment
The UK has set off on its own path in separating itself from the European regulatory framework. It has also faced its own problems due to mismanagement. In an attempt to address what at best would be called a missed opportunity, the MHRA recently amended the UK Clinical Trials Regulations. The reforms introduced risk-proportionate approaches, a notifiable-trial route and changes intended to accelerate first-in-human studies and lower-risk modifications [18].
Practical applications have not yet met the MHRA’s stated vision. However, Route B is a particularly interesting initiative. Eligible modifications can now be automatically approved unless concerns are raised within 14 calendar days [19]. It has yet to be seen what this means in terms of trail numbers.
On paper at least, the UK hopes to deliver something conceptually similar to the FDA: reduce regulatory friction while maintaining scientific and participant safeguards. But regulation is only part of the equation. The UKs population is smaller that of the US and the NHS research infrastructure under pressure and persistent challenges around contracting and site activation. Older UK evidence demonstrated how long bureaucratic processes delay site opening, while more recent international evidence shows that such problems are not unique to the UK [7][20]. Brexit may provide the UK with greater freedom to redesign its regulatory system. It does not magically deliver study ready sites and participants.
Ecosystem: The real competition
This is where the FDA’s challenge becomes clearer. Research into clinical-trial site selection consistently shows that sponsors care deeply about recruitment, investigator capability, site resources, data quality and operational commitment [2][3]. Regulatory speed matters, but it is not enough. Biotechs need systems capable of delivering the entire sequence. That means regulators, ethics committees, investigators, hospitals, CROs, contract offices, manufacturing, patients, venture capital and pharmaceutical partners. It also requires leadership.
Drug-development organisations involve increasingly complex networks in which expertise is distributed across companies, academic institutions, CROs and specialist teams. Research suggests that innovation increasingly depends on organisational structures capable of connecting these dispersed sources of expertise [21]. Work examining R&D leadership similarly highlights the importance of distributed leadership rather than relying solely on centrally positioned decision-makers [22].
The implication for US policy is uncomfortable. It takes a government time to change regulations. Changing an ecosystem is harder.
Biotech choices
Returning to our biotech and their $30–50 million in cash and one valuable asset. The decision as to where to ‘go-clinical’ is unlikely to be based on regulatory prestige. It will more likely be based on questions such as:
This is why the FDA reforms are necessary but cannot, by themselves, settle the competitive question. The agency can potentially make the regulatory gateway faster and more predictable. That could materially improve the US proposition. But if the subsequent journey remains slow, the competitive advantage simply evaporates.
Can America lead?
There are three possible futures for the FDA. The first is incremental improvement. FDA reforms reduce unnecessary regulatory work, improve sponsor understanding and remove typical CMC delays. US competitiveness improves (but so will that of its competitors).
The second is system transformation in which the FDA reform is accompanied by improvements in IRBs, contracts, site activation, recruitment, digital infrastructure, trial design and evidence generation. In this scenario, the US delivers something much more powerful than a faster regulator: a faster development ecosystem.
The third is a faster front door and the same slow road. This is where the biggest threat sits. The FDA could make an IND process considerably more efficient while sponsors continue to face the institutional and operational delays that occur afterwards. The evidence already indicate that such delays matter [7][8].
No need to beat everyone
Whether the US can become the fastest place in the world to conduct every clinical trial is probably the wrong question. The more useful definition of success is whether the US can become fast enough, predictable enough and scientifically attractive enough for a biotech to not feel compelled to get its first patient data elsewhere.
Despite the issues that emerge on closer inspection, Australia has built a credible early-phase proposition. China has developed an increasingly formidable combination of scale, infrastructure and domestic innovation. Europe is attempting to reduce the friction created by its attempts to iron out perceived fragmentation. The UK has embarked on its own regulatory reset. The FDA recognises that the US cannot simply rely on the historic gravitational pull of American science, capital and pharmaceutical expertise. “Buy American” is little more than a platitude in the post-MAGA world. Its reforms are significant. But they are only the beginning.
The FDA may be fixing the front door. America will only win back the race to first patient if it fixes the road behind it. The next phase of global clinical-development competition will not be won by regulatory speed alone. It will be won by the jurisdiction capable of combining speed, predictability, scientific quality, patients, infrastructure, capital and regulatory credibility. And that is a much harder race to win.
References
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