Drug traceability and serialization represent one of the most significant challenges for the international pharmaceutical industry. The shared goal is to ensure that every package of medicine released onto the market is authentic, safe, and traceable throughout the supply chain, minimizing the risk of counterfeiting and shortages.
In Europe, the Anti-Counterfeiting Directive (AFD) introduced the requirement to affix unique codes and tamper-evident devices to prescription medicine packaging. This serialization system allows manufacturers, wholesalers, and pharmacies to verify drug authenticity through the centralized European database, thus increasing patient and healthcare professional trust.
In the United States, this evolution is being marked by the Drug Supply Chain Security Act (DSCSA) . After a phased implementation phase, the system provides for the electronic tracking of each package, with full implementation expected by November 2025, after the FDA granted an extension to certain supply chain players, such as wholesalers and third-party logistics providers (3PLs). This step marks a crucial shift: every package of medicine will be monitored in real time throughout the entire distribution chain.
Best practices for companies that want to be ready include:
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implement advanced serialization systems integrated with ERP and WMS;
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ensure the management of unique codes compliant with GS1 standards;
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arrange for distributor verification checks to ensure product integrity;
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maintain constant alignment with regulatory deadlines in different markets.
For pharmaceutical companies and distributors, the ability to adapt their Track & Trace systems to European and US regulations will be crucial not only for compliance, but also for building a resilient and transparent supply chain.
Browse our guides for practical implementation examples and concrete solutions for your business.
