Reimagining Global Drug Approvals: How Regulatory Reliance Is Transforming Patient Access
For decades, pharmaceutical companies have grappled with a frustrating reality: bringing a post-approval change to market globally could take up to seven, or in some cases more, years. That meant patients in some countries had to wait years longer than others to benefit from manufacturing improvements, new production sites, or process enhancements. But a shift is underway in the regulatory world, and it's fundamentally changing how drugs get approved across borders. In a presentation at the 2026 ISPE Facilities of the Future Conference, Bob Iser, Vice President of Quality Policy and Advocacy at Genentech/Roche, shared his company's journey through regulatory reliance pathways, and the results are nothing short of remarkable.
His keynote emphasized the critical role of regulatory reliance—global health authorities leveraging each other’s assessments and inspections—to accelerate approval of post-approval changes and ensure consistent, timely access to medicines worldwide.
The Vision That Started It All
In 2011, Roche/Genentech articulated their "Blue Sky Vision": one product, one regulatory standard, one inspection, and one assessment. At the time, it seemed almost impossibly ambitious. The pharmaceutical industry was fragmented across regulatory jurisdictions, with each country maintaining its own approval processes, inspection requirements, and assessment standards. A single manufacturing change could trigger a cascade of separate submissions, inspections, and approval timelines that stretched across continents and years.
Fast forward to today, and something extraordinary has happened. Not only has the industry made significant progress toward this vision, but regulatory authorities themselves have adopted nearly identical language. In 2024, the European Medicines Agency (EMA) presented slides referring to "single submission, single assessment, single agreed outcome,” almost word-for-word matching what Genentech had envisioned over a decade earlier. Even the US Food and Drug Administration (US FDA) has joined the chorus, adding "one inspection" to their collaborative vision.
The Challenge: A Seven-Year Wait
To understand why this matters, consider the baseline Iser shared. Historically, a post-approval change, such as transferring production to a new facility or implementing an improved manufacturing process, required five to seven, or maybe even more, years to achieve global approval. Think about what that means in practical terms: a company develops a better way to manufacture a life-saving drug, but patients in many countries must wait the better part of a decade to benefit from that improvement.
Through various reliance initiatives and collaborative efforts, the timeline has already been reduced to three to five years. But Genentech's ambition is bolder still: 18 months for global approval. And they're not just talking about aspirations, they're achieving it through participation in regulatory reliance pilots.
What Is Regulatory Reliance?
Regulatory reliance is a framework in which one health authority relies on the assessment work of another health authority rather than duplicating the entire review process. Instead of every country conducting its own independent assessment and inspection, reliance allows regulators to share information, coordinate their work, and ultimately depend on each other's expertise and findings.
The concept isn't just about efficiency for pharmaceutical companies, though that is certainly a benefit. It's fundamentally about better use of limited regulatory resources and, most importantly, faster access to medicines for patients worldwide. Reliance pathways allow smaller countries to leverage assessments by more established authorities, ensuring their populations have access to safe, effective medicines without the delays caused by duplicative reviews.
Why Now?
Iser posed an interesting question during his presentation: "Why now?" But he quickly reframed it as "Why not now?" The convergence of several factors has created an unprecedented opportunity for regulatory transformation:
Lessons from the Pandemic: COVID-19 forced global health authorities to collaborate in ways they never had before. The world got smaller, communication improved, and regulators discovered they could work together effectively under pressure. Those lessons haven't been forgotten.
Technology: New information-sharing platforms, AI tools for assessment, and structured data formats are making collaboration technically feasible in ways that weren't possible a decade ago.
International Harmonization Efforts: Organizations like the International Council for Harmonisation (ICH) have developed guidelines—particularly ICH Q12 on lifecycle management—that provide common frameworks for post-approval changes.
Mutual Recognition Agreements: Bilateral and multilateral agreements between regulatory authorities have laid the groundwork for mutual recognition of each other's work.
Pilot Programs: Multiple engagement pathways and pilot programs have demonstrated that regulatory collaboration can work and deliver tangible benefits.
The International Coalition of Medicines Regulatory Authorities (ICMRA) Pilots: Proof of Concept
The ICMRA launched collaborative assessment pilots that have produced impressive results. In the first round, five joint assessments were completed with harmonized outcomes in just 120 days. Perhaps more importantly, these collaborative assessments resulted in 25 percent fewer information requests sent to companies, a clear sign of improved efficiency.
Genentech participated in the second round of these pilots through a drug-substance manufacturing-site transfer. The submission involved four major regulatory authorities: the US FDA, the European Union, the UK, and Switzerland. In December 2025, all four authorities approved the change management protocol simultaneously significant achievement that would have been nearly impossible under the old system.
The Inspection Challenge
While collaborative assessments have been successful, inspections present unique challenges. Different regulatory authorities conduct inspections for different reasons and at different times. The US FDA, for instance, requires pre-approval inspections for new facilities, while other authorities may have different triggers.
The Collaborative Hybrid Inspection Pilot (CHIP) is tackling this complexity. Genentech participated in a CHIP pilot in 2024, with Swissmedic as the lead inspectorate, the US FDA participating remotely, and observers from the EMA and Health Canada. The pilot demonstrated that hybrid inspection models combining on-site and remote participation could work effectively while reducing the burden of multiple separate inspections.
Swissmedic's head of the inspectorate publicly announced participation in the pilot, signaling genuine regulatory enthusiasm for these new collaborative approaches. When regulators publicly acknowledge their participation, you know something meaningful is happening.
ICH Q12: The Foundation
While some have questioned whether ICH Q12 on lifecycle management has been successful, Iser, who worked on Q12 during his time at the US FDA, highlighted several important achievements. Post-Approval Change Management Protocols (PACMPs), previously known as comparability protocols, are now available in countries where they didn't previously exist. Risk-based classification of changes has been adopted by countries that previously required prior approval for all changes, regardless of significance.
These may seem like technical details, but they represent fundamental shifts in regulatory philosophy—from one-size-fits-all requirements to flexible, risk-based approaches that acknowledge the sophistication of modern pharmaceutical quality systems.
The Path Forward
Despite the progress, challenges remain. Iser was candid that collaboration, while valuable for learning, isn't the ultimate goal. True reliance, where companies submit to one authority, and others accept that assessment, is the end state that will deliver maximum efficiency and patient benefit.
Getting there requires continued participation in pilots, investment in technology infrastructure, and patience. These are long-term transformations, not overnight fixes. But the momentum is building. The fact that regulatory authorities are now using the same language and articulating the same vision as the industry suggests genuine alignment on the destination, even if the journey isn't complete.
A Culture Where Anything Is Possible
Iser concluded with a quote from Genentech Co-founder Bob Swanson: "What we tried to do in the early days of Genentech was create a culture where anything was possible." As Genentech marks its 50th anniversary, that spirit endures—not just within the company, but across the industry and among regulatory authorities worldwide.
The pharmaceutical industry stands at the cutting edge of countless technologies, from cell and gene therapies to advanced biologics and AI-driven drug discovery. As Iser noted, it would be a shame if we couldn't bring these innovations to patients quickly due to regulatory barriers. Progress in regulatory reliance suggests otherwise.
Looking Ahead: Hope and Commitment
The transformation of global drug regulation from a fragmented, duplicative system to one based on reliance and collaboration is well underway. The timeline for global post-approval changes has already been cut in half, and companies like Genentech are demonstrating that the 18-month target isn't just aspirational—it's achievable. Pilots involving dozens of countries are demonstrating that reliance works, delivering faster patient access without compromising safety or quality.
But this progress didn't happen by accident. It required senior leadership commitment, patience for the long game, and willingness to invest time and resources in pilots and collaborative initiatives. It required regulators willing to trust one another and the industry willing to pioneer new pathways. Most importantly, it required everyone to keep their eyes on what matters most: patients waiting for access to lifesaving and life-improving medicines. As these reliance pathways mature from pilots to standard practice, that seven-year wait for global approvals will become a relic of the past—and patients everywhere will be better for it.
Conclusion
Regulators, including EMA and US FDA, are now publicly aligned with the long-standing industry vision: one product, one regulatory standard, one assessment, one inspection (or potentially none), signaling meaningful convergence ahead.
Overall Implication: The convergence of regulatory collaboration, technological modernization, and shared global standards is accelerating the pace at which companies can implement changes, innovate, and deliver therapies to patients worldwide. Continued industry participation in pilots and early engagement with regulators will be essential to realizing full reliance adoption.
DISCLAIMER
This is a summary of a presentation made on 3 February at the 2026 ISPE Facilities of the Future Conference in San Diego, California, US. It has not been vetted by any of the regulators or agencies mentioned in this article, nor should it be considered the official positions of any of the agencies mentioned.
About the Presenter, Bob Iser
Bob Iser is the Global Head of Quality Policy and Advocacy at Genentech (Roche), drawing on 30 years of experience ensuring lifesaving medicines are produced at the highest quality and in compliance with global health authority regulations. He is a senior leader who leverages deep experience as a former regulator (US FDA), a practical biotech industry professional, and a global consultant to address complex quality, CGMP compliance, and regulatory challenges. Passionate about influencing policy, Mr. Iser has been a frequent contributor on CMC, CGMP, and US FDA policy topics to expert groups such as ICH, USP, ISPE, PDA, PhRMA, and AAM.
