From Momentum to Standard: What We’re Seeing Across the Ecosystem

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.