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Not long ago, the idea of submitting to dozens of regulatory agencies at the same time would have been considered overwhelming, if not impossible.

Today, it’s happening, thanks to innovative pathways powered by cloud technology.

Across the ecosystem, we are seeing biopharma submit to regulators simultaneously, engage in real-time dialogue, and significantly compress approval timelines. In some cases, what historically took three plus years is being achieved in under a year. The implications are deeply human. Therapeutic innovation is reaching patients faster than the industry has ever been able to deliver before.

At the same time, regulatory agencies worldwide are under increasing workload pressure and exploring innovative ways to accelerate reviews while upholding the highest standards of quality, safety, and efficacy, while also preserving their sovereign decision-making authority. The EMA, for example, recently reported 31 PAC reliance pilots to date, with nine finalized, eight ongoing, and 14 more expected to begin in 2026. Participation is also expanding, with 77 countries already involved in one or more finalized or ongoing pilots—a number that continues to grow. The results have been consistent: faster approvals, greater harmonization, reduced workload, and improved supply continuity.

From where we sit, supporting real submissions and facilitating exchange between industry and regulators, this momentum feels different from past waves of innovation. For decades, global regulatory exchange has followed a sequential pattern. A submission is made in one market, reviewed, and then adapted and resubmitted to the next. Questions are asked and answered in isolation. The same work is repeated across countries, not because anyone intends inefficiency, but because the system has historically made it the operational norm.

What we are seeing now is the emergence of an alternative to older ways of working. One that reflects the realities of a connected, digital world powering regulatory innovative pathways.

Instead of one market at a time, submissions are happening across many. Instead of fragmented exchanges, regulators are working with greater visibility into shared data and responses, built on trust and transparency. Instead of recreating dossiers country by country, companies are beginning to operate from a single, aligned global submission. The shift may sound incremental on paper, but in practice it fundamentally changes how work gets done.

From “Pilot” to Practice

One of the most notable aspects of this transition is how regulators themselves are engaging. Increasingly, they are not just participating in these efforts. Rather, they are seeking them out. We are seeing agencies request inclusion in submissions, ask for earlier access to data, and engage more actively in collaborative review processes. There is also a growing willingness to align requirements and reduce steps that once added time without truly added value.

That change in posture matters. Reliance has always depended on trust. Trust in the data, in the assessment, and in the process itself. What we are seeing now is that transparency, enabled by cloud technology such as the Accumulus platform and real-time exchange, is helping to build that trust in a way that was previously difficult to achieve at scale.

And yet, despite the progress, much of this work is still described as “pilot.”

From an operational perspective, that label is becoming increasingly misleading. These are not theoretical exercises. They involve live submissions, real products, and decisions that directly impact patient access. The reason the term persists is not because the model is unproven, but because it has not yet been embedded into the standard way of working and/or formalized in agency official guidance.

That distinction matters, because it points to the next challenge.

What It Takes to Make This the Standard

Momentum alone will not make this the default.

Reliance, by its nature, is collaborative. But collaboration at global scale requires more than aligned intent, it requires infrastructure. Many of the existing systems and processes in regulatory affairs were built for a document-centric, sequential world. As reliance expands, those legacy approaches can create friction, limiting how far and how fast these new models can scale.

What is becoming clear is that enabling reliance at scale means enabling a different kind of exchange: one that is simultaneous rather than sequential, transparent rather than siloed, and integrated rather than duplicative.

That is the role the Accumulus platform is playing today. By providing a shared platform for real-time regulatory exchange, we are helping to operationalize what reliance has always aimed to achieve: one action reaching many agencies, with visibility and collaboration built in from the start. The Accumulus platform network now connects more than 70 regulators across six continents, and it continues to grow as both industry and agencies recognize the value of working this way. 

The Measure That Matters

What we are witnessing is not the beginning of a shift, but the middle of one. It’s fascinating to see agencies around the world collaborating without geographic or political barriers, united by the shared goal of accelerating therapies for the populations they serve. 

The pieces are coming together: regulatory pathways are evolving, technology is enabling new workflows, and both industry and regulators are demonstrating a willingness to work differently. The question now is how quickly it becomes routine.

From our perspective, the next phase will be defined by scale and normalization. More programs will move through these pathways. More regulators will participate as a matter of course. Companies will begin to build repeatable processes rather than treating each effort as a one-off. Over time, what is currently described as innovative will simply become expected.

That transition requires continued collaboration, updates to regulatory frameworks, and thoughtful change management across organizations. But the direction is clear, and the progress to date suggests that the rate of change may be faster than many anticipated.

Ultimately, this is about more than efficiency or modernization, but rather about what becomes possible when the barriers between organizations, markets, and regulators begin to fall away. When submissions can be shared once instead of many times. When questions are answered collectively rather than repeatedly. When decisions are informed by a broader, more connected view of the data.

For patients, that translates into something very concrete: time.

Time gained in development.
Time saved in approval.
Time brought forward in access.

And that is the measure that matters most.

The limitations of sequential submissions are no longer theoretical—they are structural, measurable, and increasingly untenable.

For decades, regulatory execution has followed a market-by-market approach. What began as a practical necessity has become a systemic constraint. As global expansion accelerates and pressure on speed and efficiency intensifies, the consequences of this model are becoming harder to ignore.

When submissions move sequentially, the impact extends far beyond timelines.

Drug lag increases, delaying patient access not because of science or safety, but because of process. Approvals cascade one market at a time, compounding delays across regions and extending the time it takes for therapies to reach patients globally.

At the same time, lifetime revenue is reduced. Each delay pushes approvals further into the product lifecycle, shortening the window for full commercialization. Lost time at the front end of global rollout translates directly into lost value.

Patent protection is also eroded. While submissions progress sequentially, the patent clock continues to run. Protected time is consumed without corresponding access, compressing return on R&D investment and weakening the economics of innovation.

Operationally, cost rises as duplication becomes embedded in the process. Regulatory teams repeat the same work across markets—authoring, responding, and revalidating—shifting effort away from strategy toward process management.

And perhaps most importantly, portfolio velocity slows. When resources are tied up executing submissions one at a time, fewer products, variations, and expansions can move forward in parallel, limiting global scale and increasing concentration risk.

But the most critical consequence is this: patients wait.

These delays are not evenly distributed. Patients in low- and middle-income countries often experience the longest gaps—waiting years for access to therapies that are already approved, safe, and available elsewhere. Sequential models reinforce disparities that modern regulatory systems are increasingly capable of eliminating.

A New Operating Standard Is Emerging

The industry is now at an inflection point.

Simultaneous submissions—supported by shared visibility and coordinated review across markets—are redefining what regulatory execution can look like. This model replaces multi-year, wave-based timelines with parallel engagement, enabling approvals in months rather than years.

What was once constrained by feasibility is now enabled by infrastructure.

Leading organizations are no longer focused on managing sequential execution. They are optimizing for global regulatory performance—executing across markets in parallel, with coordination rather than delay.

When supported by fit-for-purpose digital infrastructure, simultaneous submissions unlock a fundamentally different set of capabilities:

1. Regulatory reliance becomes operational, not theoretical
When multiple regulatory authorities receive the same submission at the same time, reliance can be applied during review—not just after approval. Insights, questions, and assessments can inform parallel reviews, reducing duplication while preserving independent decision-making.

2. Review cycles run in parallel rather than in series
Instead of waiting for approvals to cascade, reviews proceed concurrently. Timelines shift from cumulative to overlapping, dramatically accelerating the path to global approval.

3. Redundant work is reduced across markets
Shared visibility into submissions and responses minimizes repeated authoring and rework. Regulatory effort is focused where it adds value, rather than reproducing the same activities market by market.

4. Global timelines are compressed by years
What historically required multiple years through wave submissions can now be achieved in a fraction of the time—protecting product value and increasing portfolio throughput.

5. Patients gain access sooner, regardless of geography
By enabling earlier approvals across regions, simultaneous submissions reduce disparities in access—particularly in markets that have traditionally experienced the longest delays.

From Constraint to Choice

Technology is no longer the limiting factor.

The shift from sequential to simultaneous is ultimately a shift in mindset: from managing process to enabling performance, from local execution to global coordination, from delay as a constraint to speed as a system capability.

But at its core, this is not just an operational decision—it is a patient one.

Every month gained in regulatory timelines is a month patients receive treatment sooner. Every market reached in parallel is a population no longer asked to wait its turn. And every reduction in duplication is an opportunity to focus more effort on delivering safe, effective therapies where they are needed most.

The future of regulatory submissions will not be defined by how efficiently we manage delay, but by how effectively we eliminate it for patients everywhere.Now is the time to act.

If you’re exploring how to transition from sequential execution to a simultaneous model, click below to learn more.

The life sciences industry has spent decades scaling scientific innovation, yet regulatory operations remain constrained by a model built for a paper-based era. For most biopharmaceutical companies, regulatory submissions follow a slow, sequential pattern known as the wave model. A change is approved in one country, then cascades market by market, often taking years to finally reach global approval. Each step depends on the one before it, locking sponsors and regulators into an outdated, linear process. 

This isn’t just an efficiency issue.

What was once accepted as inevitable is now becoming a competitive and access-limiting constraint. The wave model has become an increasingly costly operating structure that:

• Drives drug lag
• Inflates regulatory burden
• Compresses patent value
• Erodes lifetime revenue

Most critically, it delays patient access by months or even years despite the science being ready.

The critical vantage point

At Accumulus Technologies we work at the intersection of life sciences organizations and national regulatory authorities (NRAs) to enable real-time regulatory collaboration. This vantage point affords us a front-row view into what’s driving delays – and what’s changing fast.

One shift is unmistakable: the era of waiting in line is ending.

In 2026, we believe the industry will cross a tipping point: organizations will shift from managing sequential regulatory execution to optimizing global regulatory performance through parallel, coordinated engagement.  

For a deeper look at why we believe the era of waiting in line is over and our predictions for what comes next, download our latest industry perspective.