U.S. and EU Regulators and Industry Grappling with Track-and-trace Standards to Combat Drug Counterfeiting
This article was originally published in The Gold Sheet
Pharmaceutical industry groups and lawmakers in the U.S. and the EU are continuing to grapple with what a pharmaceutical track-and-trace system will look like to thwart drug counterfeiting. The EU has three different track-and-trace models with various levels of traceability in each, while in the U.S., efforts to attach a national traceability system to the user fee legislation failed to garner consensus on the best approach, and meanwhile industry is instituting brand protection programs.
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November signing of Drug Quality and Security Act into law sets in motion a deadline-packed three-phase process of establishing tracing and serialization requirements for drug products to protect the U.S. market from counterfeits.
The European Union July 1 published its directive on falsified medicines, setting into motion a tightening of Europe’s pharmaceutical supply chain that will for the most part take place over the next 18 months – and that could cost pharmaceutical companies billions of Euros.
Anti-counterfeiting traceability pilot under way in Europe.