EFPIA Starts Traceability Pilot Program to Combat Drug Counterfeiting
This article was originally published in The Gold Sheet
Anti-counterfeiting traceability pilot under way in Europe.
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Europe is largely ignoring drugs theft while focusing on medicines counterfeiting, but a new Italian report could spur stakeholders to unify behind EFPIA's supply chain tracking system.
U.S. and EU Regulators and Industry Grappling with Track-and-trace Standards to Combat Drug Counterfeiting
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.
More flexibility, greater accountability for APIs expected in Europe with new guidelines on the European Union's variations regulation and an anti-counterfeiting legislative proposal, say speakers at APIC/CEFIC meeting in Paris. The European Parliament has agreed with a European Commission proposal to require communitywide alignment of member state variations requirements, and to allow more types of manufacturing changes to proceed without prior approval. However, EU API makers have some concerns. Quality by design for APIs discussed. European Commission proposes counterfeit directive requiring tracking features, audits of API manufacturers and posting of inspection results. Tips shared for auditing API suppliers and traders.