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EU Moving to Tighten GMP Requirements on Outsourcing and Supply Chain Control

Changes to the EU regulations that govern technical agreements, outsourced activities, active pharmaceutical ingredient (API) supply chains, and the storage and transit of medicines are in progress and expected to be released soon for public consultation....

EU and Cambodia Take Steps to Fight Counterfeit Drugs

The EU and Cambodia have recently taken additional steps in the fight against counterfeit drugs: the Council of Europe (EC) updated the EU draft guidance on “falsified medicines,” and Cambodia initiated a crackdown on illegal pharmacies operating in their country.....

European Trade Associations Step Up to the Plate on Drug Counterfeiting

Two trade associations in Europe, through separate but related efforts, are advancing the dialogue on preventing counterfeit medicines from entering the legitimate drug supply chain: one by publishing a set of guiding principles to call attention to the issue; the other by successfully executing a pilot program on security of drug products in the supply chain....

FDA Shares Concerns, Expectations Regarding Pharma Cargo Thefts

FDA sent a letter to medical companies expressing concern about the increase in cargo thefts of FDA-regulated drug products, and clarifying its expectations from companies and the agency’s role when thefts occur....
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