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U.S. and EU Regulators and Industry Grappling with Track-and-trace Standards to Combat Drug Counterfeiting

 
• By Joanne S. Eglovitch

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.

Pharmaceutical industry groups as well as lawmakers in the U.S. and the European Union are devising a number of different approaches to implementing drug traceability with various levels of track and trace to fight drug counterfeiting.

In the EU, three different models of track and trace are being developed with different levels of governance.

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