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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

Executive Summary

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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