Drug traceability in 2026: why it's no longer optional for the pharmaceutical industry

La traceability of drugs ceased to be a trend and became a global regulatory and health security requirement. With increasingly strict systems based on international standards, manufacturers and distributors face new challenges to protect patients, ensure the authenticity of their products and remain competitive in global markets.

An increasingly demanding regulatory environment

Several countries and regions have strengthened their serialization and traceability mandates to ensure supply integrity:

• Europe requires GS1 DataMatrix codes with full serialization (GTIN, serial number, lot and expiration), with verification schemes moving forward to 2027.
• Africa is progressing with mandatory reports via EPCIS for national Track & Trace systems during 2026.
• Gulf (GCC) it already operates with interoperable GS1 ecosystems for import and export.

👉 The requirement is global and multidirectional: those who cannot draw will be left out of markets.

The threat of counterfeit drugs remains high

The World Health Organization estimates that up to 1 in 10 drugs in certain regions may be counterfeit or sub-standard. This impacts:

• Patient safety
• Reputation of laboratories
• Costs for recalls and sanctions
• Losses due to diversions and parallel markets

Without digital visibility, detecting the problem is nearly impossible.

Argentina: stricter controls

The ANMAT deepened the traceability criteria for high-risk substances, with online reports of each logistics event and more frequent audits.

The focus is no longer just serializing, but demonstrating the complete product journey.

Faced with this context, the question is no longer “whether to implement traceability”, but with what platform to do so without holding back the business.

Verifarma's Track & Trace solution

Frictionless compliance

• Native serialization under standards GS1
• Connecting to local regulatory repositories
• Management of automatic reports by market
• Validation of events required by authorities

Real visibility of the chain

• Unit-to-unit traceability
• Batch and aggregation tracking
• Early detection of deviations
• Real-time distribution maps

Recall-ready operation

• Immediate identification of affected batches
• Selective product blocking
• Agile communication with distributors and pharmacies

Integration with the laboratory ecosystem

• Connection with ERP, WMS and packaging lines
• Onboarding with logistics operators
• Third-party management without losing control of the data

Track & Trace as a competitive advantage

Beyond compliance, a robust platform allows:

✅ Reduce losses due to diversions
✅ Protect the brand against counterfeiting
✅ Speed up audits
✅ Export to multiple markets
✅ Make decisions with real data

In 2026, traceability is a business pillar.
Companies that approach it only as an obligation will see costs; those that integrate it strategically will gain control, efficiency and trust.

💡 Does your current system allow you to meet these requirements without rework?
👉 Request a demo and learn how to implement it without interrupting your operation.