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FDASIA Title VII Empowers FDA in Supply Chain Arena; Congress Adds Other Tools to Help on Drug Shortages and Theft

Title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA) gives FDA additional tools it has been seeking to better confront the challenges of regulating a global supply chain....

USP Releases New Draft General Chapter on Good Distribution Practices and Supply Chain Integrity

USP has released for comment a new draft general chapter <1083> titled “Good Distribution Practices – Supply Chain Integrity” that will be expand its series of information chapters addressing various aspects of the pharmaceutical supply chain. The formal proposal will be published in March/April issue of Pharmacopeial Forum.  Comments are due by May 31. An advance […]

EDQM Launches Harmonized Serialization Program eTACT to Strengthen Europe’s Anticounterfeiting Efforts

On January 26th and 27th, the European Directorate for the Quality of Medicines & Healthcare (EDQM) officially launched its “eTACT” anti-counterfeiting IT-based traceability service with a workshop and live demonstration at its Strasbourg, France headquarters....

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....

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.”

FDA Guidance Finalized on Tab/Cap Physical-Chemical IDs

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FDA Releases Report on Drug Diversion and Counterfeiting Cases

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