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China Seizes $315M in Counterfeit Drugs and Arrests 1,770 Suspects

Chinese police seized two billion yuan ($315-million) in counterfeit drugs and arrested over 1,700 suspects in a nation-wide crackdown on fake medicines in late November, according to the international news organization AFP. AFP cited a press release from China’s Ministry of Public Security, which stated that over 1,400 “dens” that made or sold counterfeit medicines […]

EC Publishes Concept Paper on Safety Features to Support Falsified Medicines Legislation

In mid-October, the European Commission (EC) published a concept paper for public consultation on proposed requirements for “safety features” for medicinal products as part of its implementation of the EU falsified medicines legislation. Comments are due by April 27, 2012....

Anticounterfeiting Initiatives on Criminal Penalties and Serialization Advance in the US and Europe

Lawmakers in the US and Europe are moving forward with initiatives to significantly increase criminal and monetary penalties for the manufacture and distribution of counterfeit drugs and to create an internationally-harmonized serialization system....

Hydrochloric Acid Shortage Prompts Testing of Incoming Shipments

A recent shortage of technical grade hydrochloric acid (HCl) is beginning to impact the supply of high purity HCl used in pharma manufacturing, according to the supply chain consortium Rx-360.  It has confirmed the shortage condition and notes that there have been recent reports of specification failures of HCl tested at incoming inspection at some […]

Council of Europe Bolsters Anticounterfeiting Efforts with Framework for Criminal Penalties

The Council of Europe has taken a major step to in its effort to fight the growing problem of counterfeit medicines by adopting a convention that includes, for the first time, criminal penalties for counterfeiting medicines, marketing medicines without authorization, being non-compliant with conformity requirements or falsifying related documents. The scope of the “Medicrime Convention,” […]

WHO Reaffirms Role in Medicine Safety and Access

A World Health Organization working group has drafted a two-page resolution that backs WHO's role in ensuring the public's access to safe, effective and affordable medicines of acceptable quality. However, Rx-360 notes in its analysis of the resolution that it “indicates that the agency should take something of a back seat on the topic of what have become known as substandard/spurious/falsely-labeled/falsified/counterfeit (SSFFC) medical products.”

Suppliers See Cost/Quality Disconnect in Big Pharma Decision Making

Suppliers are experiencing a significant disconnect between big pharma’s avowed quality-by-design-based supply chain objectives and the actual purchasing decisions it is making based only on price....

FDA Guidance Finalized on Tab/Cap Physical-Chemical IDs

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Pharma Purchasing and Outsourcing Approach Needs Overhauling, Supply Chain Expert Asserts

Regulatory pressure and “true cost” understanding will push pharmaceutical firms to reverse the current outsourcing trend and gain back more control of their critical ingredients and components, supply chain expert Andrew Cox asserts....

Drug Shortage Price Gouging Draws Attention of Congress, Media

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