What pharmaceutical traceability can teach us about moving from regulatory requirements to operational readiness
The Digital Product Passport is moving from framework to implementation.
The EU Digital Product Passport Registry became operational on 20 July 2026. The Registry provides an important piece of the DPP infrastructure, giving economic operators a central EU-level system for registering and finding passport-related information, while detailed product information remains in the relevant decentralized systems. The European Commission has also established a testing environment and support resources for organizations preparing to use the system.
The technical foundation is progressing at the same time. CEN-CENELEC JTC 24 has developed standards covering areas including unique identifiers, interoperability, data carriers, APIs, data exchange and data storage.
The first major sector-specific milestone is now approaching.
18 February 2027 is the date from which the Battery Passport becomes mandatory for relevant electric vehicle batteries, light means of transport batteries and industrial batteries above 2 kWh placed on the EU market. Other sectors will follow through the DPP implementation roadmap, including textiles, construction products, aluminium, tyres, furniture and mattresses.
The DPP journey is therefore no longer theoretical.
But there is a question behind all these dates:
What happens when a regulatory timetable meets the reality of implementation?
A perspective from pharmaceutical traceability
My perspective comes from more than a decade implementing traceability solutions in the life sciences industry.
I documented much of this experience in my book, Track and Trace for Supply Chain Visibility in Pharmaceuticals, Beverages, Foods and Cosmetics, published in 2024. The book covers serialization, standards, regulations, track & trace software, system integration, vision inspection and the practical elements required to implement traceability systems in regulated environments.
It was written with a broader objective: to use experience from life sciences to help other industries understand what implementing traceability really means.
I also previously examined the fundamentals of Digital Product Passports in my Packaging Europe commentary, Everything You Need to Know About Digital Product Passports.
The question has now changed.
The DPP concept is becoming infrastructure. The more interesting question is how organisations will move from regulatory requirements and standards to functioning systems.
Pharmaceutical traceability provides a useful precedent.
DSCSA: regulation meets ecosystem readiness
The US Drug Supply Chain Security Act (DSCSA) introduced a phased approach to pharmaceutical traceability, progressively increasing requirements across manufacturers, repackagers, wholesale distributors and dispensers.
The enhanced electronic tracing requirements introduced in November 2023 provide a particularly relevant example.
The FDA established a one-year stabilization period from 27 November 2023 through 27 November 2024, giving trading partners additional time to build, validate, troubleshoot and mature interoperable systems and processes.
The process did not simply stop when the stabilization period ended.
The FDA subsequently introduced targeted exemptions for certain trading partners and small dispensers. In August 2026, for example, the FDA issued exemptions from certain DSCSA requirements for qualifying small dispensers until 27 November 2027.
The lesson is not simply that a pharmaceutical regulation was “delayed.”
The more useful observation is that the regulator used stabilization, additional implementation time and targeted exemptions to manage differences in readiness across the ecosystem.
EU FMD: one framework, different implementation paths
The European Union (EU) has a similar lesson from the Falsified Medicines Directive (FMD).
The EU FMD created a common European framework for pharmaceutical verification and serialization, but implementation has not been identical across every country.
Italy provides an interesting example.
The Italian system has followed a structured stabilization approach. The Italian National Medicines Verification System connected to the EMVS EU Hub production environment on 11 May 2026. However, that technical connection was not the end of implementation. Further onboarding activities and Pilot Phase 2 continued as the system moved towards broader operational use.
This demonstrates an important principle:
Connecting a system is not the same as completing an ecosystem.
A technical platform can be connected while manufacturers, software providers, distributors and other stakeholders are still completing their data preparation, testing and operational processes.
That distinction will also matter for DPP.
What can pharmaceutical traceability teach us about DPP?
Product identification
When a product is uniquely identified, traceability becomes possible.
In pharmaceuticals, serialization creates a mechanism for identifying individual saleable units and linking them to relevant information. It can support verification, investigations, recalls and anti-counterfeiting activities.
Serialization does not eliminate counterfeit products from the market. It creates additional barriers and verification mechanisms that can make illicit activity more difficult.
For DPP, reliable product identification will similarly be foundational, but the level of granularity may vary from lot- or batch-level identification to item-level identification.
A passport needs a dependable connection between the physical product and its digital identity.
Integration
Having systems that can communicate with each other is complex and expensive.
My book identifies the stabilization of integration between systems as one of the factors that has historically limited the development of fully integrated track & trace systems.
DPP will face the same fundamental challenge, but across an even broader range of industries and organizations.
The question will not simply be whether a company can create a DPP.
It will be whether that passport can interact reliably with the systems of suppliers, manufacturers, service providers, regulators and other ecosystem participants.
Traceability does not stop at manufacturing
For many years I have argued that traceability should start much earlier in the supply chain. I have explained the details on my article Tracking Brings Visibility from Raw Material to Customer Hands published in Supply & Demand Chain Executive.
Pharmaceutical serialization has created strong capabilities around the identification and verification of finished medicinal products and their movement through the supply chain. But this is different from the broader lifecycle visibility envisioned by DPP.
Depending on the product and regulatory requirements, a DPP can connect information about materials, production, use, maintenance, repair, recycling and end-of-life.
This creates a broader data challenge.
DPP is not simply asking:
“Where is this product?”
It can also ask:
“What is this product made of, where did relevant materials come from, how was it produced, and what should happen to it at the end of its life?”
A successful project needs more than technology
- Technology is only one component of a successful traceability project.
- Governance is required: who owns the data, who maintains it and who can make decisions?
- The right people need to be involved.
- Internal processes need to be established.
- Systems need to be tested.
- Data needs to be accurate.
- Standards need to be understood and followed.
These are not purely IT questions. They are organizational and operational questions.
This is why implementation experience matters.
What could this mean for DPP?
As DPP implementation progresses, businesses will inevitably encounter challenges.
The pharmaceutical experience suggests that complex regulatory programmes need mechanisms for managing differences in implementation maturity.
Several mechanisms are already familiar from other regulatory programmes:
- Transition periods: Additional time can allow industries to move from preparation to operational implementation.
- Phased implementation: Requirements can be introduced step by step rather than requiring the entire ecosystem to become operational simultaneously.
- Targeted treatment of smaller organisations: Smaller organisations may have different technology, financial and human-resource constraints and may require specific regulatory mechanisms.
- Stabilization periods: A defined period can allow organizations to implement, test and mature systems and processes while moving towards full compliance.
- Additional guidance: Regulators can provide clarification and practical guidance as implementation experience identifies areas of uncertainty.
- Testing and pilots: Testing environments and pilot programmes can identify technical and operational issues before requirements become fully applicable.
This does not mean that DPP deadlines will necessarily move.
There is not enough evidence to make that prediction.
The lesson from pharmaceutical traceability is different:
When complex regulatory requirements meet a large and diverse ecosystem, implementation mechanisms can become almost as important as the original deadline.
Conclusion
The DPP deadlines are now becoming part of the planning calendar for manufacturers, economic operators and technology providers.
The first major mandatory implementation date is approaching on 18 February 2027 for certain batteries.
The question that may therefore be more useful than simply asking “What is the deadline?” is:
“What really needs to be ready when the deadline arrives?”
That means more than putting a data carrier on a product.
It means having the right identification, data, governance, systems, integration, processes, testing and people in place.
Pharmaceutical serialization provides more than a decade of evidence that regulatory implementation is a journey.
The regulation establishes the framework, but the ecosystem has to make it work.
About the author: Daniel Sabín Díaz is a life sciences and traceability professional with more than a decade of experience implementing pharmaceutical serialization and track & trace solutions. He is the author of Track and Trace for Supply Chain Visibility in Pharmaceuticals, Beverages, Foods and Cosmetics (2024). Author website.
Expert commentary contributed by the author. Views expressed are those of the author.