The Next Phase of Pharma Serialisation by Ankhero Insights
In 2019, serialisation decisions were made in a state of urgency.
In 2026, those same decisions are being revisited in a state of understanding.
2019: A Reactive Phase
In 2019, pharmaceutical companies faced a hard deadline — and an even harder reality.
Regulations were coming into force. Timelines were immovable. Internal expertise was limited. Budgets were under pressure. And above all else, the objective was clear: implement quickly and remain compliant.
The market offered several options, but one vendor stood out. It was the most visible, the most widely marketed, and the name most organisations already recognised. Under intense regulatory pressure, selecting the largest and most established provider felt like the safest and fastest route to compliance.
In that environment, interoperability, data standards, and long-term conformance were rarely decisive factors. Deeper considerations — such as conformance to recognised standards including GS1 identifiers and EPCIS-based event models, and long-term interoperability across systems — were often deferred. The priority was demonstrable compliance, with the expectation that broader alignment could be addressed later.
For that moment in time, the approach was effective.
Compliance Achieved… But Understanding Deferred
As systems went live, the industry moved forward.
Serial numbers were generated. Packs were labelled and aggregated. Data was exchanged with national systems. Compliance obligations were met.
However, the focus on rapid implementation left little space for deeper consideration of long-term data ownership, system flexibility, or future operating models.
These questions were not ignored — they were simply deferred.
2026: A Deliberate Phase
Fast forward to 2026, and the industry has matured.
Serialisation systems have been operational for years. Billions of serial numbers have been commissioned, managed, and reported. Organisations now have real-world experience of how their systems perform — not only under regulatory scrutiny, but within day-to-day operations.
Many are now reassessing their landscape and asking more deliberate, regulator-familiar questions — particularly around interoperability, data standards, and ongoing conformance:
- How well does our platform conform to recognised industry and regulatory data standards?
- How consistently are GS1 identifiers and EPCIS event models implemented across connected systems?
- How easily can we adapt if our partners, markets, or operating models change?
For some organisations, the answers reveal a growing misalignment between current needs and platforms selected during the reactive phase.
Systems designed primarily for rapid rollout can:
- Limit transparency and control
- Constrain integration and interoperability
- Make change slow, complex, and costly
The industry is increasingly recognising that compliance alone is no longer a sufficient measure of success.
Migration as an Indicator of Maturity
For many years, migration between Level 4 systems was viewed as exceptional and high-risk. As a result, organisations often accepted sub-optimal platforms to avoid perceived disruption.
That view is evolving.
Interoperability and standards conformance have become central to this shift. Migration is only feasible at scale when systems share common data models, predictable interfaces, and a consistent interpretation of regulatory requirements. Without these fundamentals, flexibility remains theoretical.
As expectations move from implementation to optimisation, migration is increasingly understood as a normal consequence of strategic maturity, rather than a response to failure.
Organisations are now approaching migration with intent:
- To establish clearer ownership of serialisation data
- To improve data quality, consistency, and accessibility
- To support future regulatory, commercial, and digital requirements
These decisions are no longer driven by urgency, but by informed evaluation.
The Next Phase
Pharma serialisation has moved beyond its reactive origins.
The next phase is defined by understanding: of data, of systems, and of the standards-based interoperability that allows serialisation to remain compliant, adaptable, and demonstrably under control as requirements evolve.
Compliance was the starting point.
Understanding and ownership now define the path forward.