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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

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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EU Shaping Biotech Act To Unleash SME Potential

 
• By Neena Brizmohun

European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.

New EU Filings

 
• By Neena Brizmohun

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
• By Tim Casey

Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.