In the life sciences world, there’s been no shortage of excitement around the potential of FHIR (Fast Healthcare Interoperability Resources). As a data standard, FHIR promises to modernize how we share, update, and use health and regulatory data across systems, borders, and teams. It fosters global interoperability and reliance, reducing the amount of work and time required to move life-saving products safely across the approval stage gates. From CMC dossiers to clinical trial submission to ePI and global labels, FHIR has quickly become a synonymous with digital transformation in pharma and a catalyst for a better, more connected, and efficient future in regulatory and clinical information management.
But here’s the reality: FHIR isn’t a global standard yet—and it’s hard to predict what the future is like if it becomes one.
Only a handful of countries, such as Jordan and the EU, have begun implementing FHIR-based requirements. Others like Japan and Singapore are also making meaningful progress, particularly in areas like eLabeling and regulatory data exchange, along with Belgium and Luxembourg with the e-PIL. Still, for most of the world, FHIR remains in pilot phases or under consideration, leaving pharma teams to prepare amid uncertainty.
So, what happens in the meantime?
The Frustration: When Hype Outpaces Implementation
If you’ve been following digital transformation efforts, you’ve likely heard (or felt) the tension firsthand. There’s a growing tension in the industry about how much we’re talking about FHIR without seeing more tangible progress by most health authorities. Companies invest time and resources preparing for a FHIR-based model only to be met with unclear timelines, perpetually evolving requirements, and a sense that we’re always in the pre-launch phase.
Some regulatory professionals are already asking the question: “When are we actually going to stop talking about FHIR and start doing something with it on a broad scale?”
It’s a fair concern—and a strategic one. Planning for FHIR is essential, but what’s equally important is planning for the scenario where FHIR doesn’t become the universal standard. Because the reality is, global harmonization and reliance is a massive, slow-moving effort, and different regions will adopt standards at their own pace—if at all.
A Better Question: Is Your System Built for Change?
The question isn’t whether FHIR will succeed or fail. It’s whether your systems and processes are flexible enough to handle either scenario.
Many life sciences companies find themselves stuck with rigid tools and workflows that were built for one market, one format, or one moment in time. That’s where real risk lies—not in the success or failure of a standard like FHIR, but in the inability to adapt when the regulatory tide shifts.
That’s why future-proofing your labeling and regulatory content systems isn’t about betting on one standard. It’s about investing in platforms and partners that understand how regulations evolve—and can evolve with them.
Why We’re Building for What Comes After the Buzz
At Glemser, we’ve been working in the life sciences for over 20 years, and we’ve seen the waves of change before, SPL, IDMP, PIMS, ePI—each brining a promise of a more connected future, and each required significant investment to implement. Some stuck, some didn’t.
That experience is why our software isn’t just FHIR-ready—it’s built to adapt to whatever standards emerge across regions. Because we’re a life sciences company first, our focus is on aligning with regulations, not chasing trends. Whether your product is marketed in Jordan, Germany, Japan, or the U.S., we configure our solutions to meet the local, regional, and global standards that actually matter to your compliance strategy.
So if FHIR accelerates and becomes a true global standard, you’re ready. If it doesn’t, you’re still ready.
What Flexibility Looks Like in Practice
Here’s what we mean when we talk about future-proofing:
- Geographic Configuration: Our regulatory software for pharma is customized to align with the specific regulations and standards of the markets where your product is registered.
- Standards Agnostic: Whether it’s FHIR, IDMP, or a country-specific schema, our structured content approach is built to map to the standard, not be locked into one.
- Scalable Infrastructure: As requirements evolve, our systems scale with you—whether you’re preparing for an implementation of a global FHIR standard or managing regional FHIR implementations.
- Process Alignment: We don’t just install software—we align it with your internal teams, workflows, and regulatory strategies, ensuring long-term sustainability no matter how the landscape shifts. Need to submit a regulatory filing through a portal like Accumulus Synergy and directly to a Health Authority? We’ve got you covered.
Staying Ahead Without Betting the Farm
The future of FHIR may still be unwritten. But that doesn’t mean companies have to stay frozen in wait-and-see mode. Now is the time to act—not by committing to one format, but by committing to flexibility.
Investing in adaptable systems today puts you in a position to scale, respond, and lead—regardless of whether FHIR becomes the global standard or another model takes its place.
Digital transformation in life sciences will continue—with or without FHIR. The question is whether you’re ready for it.
Interested in learning how to adapt your labeling processes without locking into a single standard? Contact Glemser today to get started.
