Which global regulatory framework, implemented in regions like the European Union, required track-and-trace based on unique product identifiers?

Answer

The Falsified Medicines Directive (FMD)

While the DSCSA drove US implementation, global efforts toward serialization and track-and-trace mirror similar regulatory mandates elsewhere, aimed consistently at patient safety. In the European Union, the framework established to address these concerns was the Falsified Medicines Directive (FMD). This directive implemented a sophisticated verification system centered on unique product identifiers affixed to medicines. Although the implementation methods and timelines might differ from those in the US, the FMD shares the core goal of creating an auditable chain of custody for pharmaceuticals to prevent fraudulent products from reaching patients. The comparison between FMD and DSCSA illustrates that while the intent is universal, the method of serialization implementation can vary regionally.

Which global regulatory framework, implemented in regions like the European Union, required track-and-trace based on unique product identifiers?

Related Questions

Which act established the clear timeline for phasing in unit-level tracking for the US drug supply chain?What mechanism electronically links serialized units, like individual blister packs, to their next level of packaging, such as an outer carton?What fundamental requirement distinguishes modern supply chain serialization from earlier tracking methods like batch or case tracking?Which individual is cited as being instrumental in defining the scope of modern supply chain thinking that preceded serialization?What key characteristic ensures that a manufacturer's serialized data can communicate successfully with a wholesaler's system, regardless of software vendor?What is the typical 2D barcode format utilized to encode the serialized National Drug Code and associated data on individual pharmaceutical containers?Beyond mitigating counterfeit risk, what long-term operational benefit does precise unit serialization enable for managing product recalls?What crucial element must be present on a pharmaceutical unit alongside the unique serialized NDC for regulatory tracking purposes?What operational constraint necessitates significant scaling of IT infrastructure when moving to high-volume unit verification?Which global regulatory framework, implemented in regions like the European Union, required track-and-trace based on unique product identifiers?
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