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EDQM Launches Anti-Counterfeiting Database

In late March, as part of its anti-counterfeiting activities, EDQM announced the launch of a new database called “Know-X.” The database collates reports on counterfeit/falsified medical products that have been detected in European member states, and also contains details on closed cases of counterfeit/falsified medical products, technical information on the testing performed, the authorities involved, […]

Congressional Hearing on Counterfeit Drugs and Supply Chain

A February 27th hearing was held by the House of Representatives’ Committee on Energy and Commerce to discuss the FDA effort to combat counterfeit drugs and what additional authorities may be needed to aid this effort. Appearing at the hearing were FDA Deputy Commissioner Howard Sklamberg, Elizabeth Jungman of Pew Charitable Trusts, as well as […]

EDQM Launches Webpage on Counterfeit Medicines

EDQM has launched a new website capturing its activities in the field of “Counterfeit Medicines and Similar Crimes.” The website covers risk communication, facts, and practical advice regarding counterfeit issues. The website also lays out legislative, public health, and criminal legal strategies.

FDA Increasing Involvement with Europol on Counterfeiting

FDA is expanding its collaboration with Europe in the fight against counterfeiting. The agency is placing an agent from its Office of Criminal Investigations within the EU law enforcement agency, Europol. A key focus of the joint effort is illegal website pharmacy trafficking.

FDA Accredits GS1 and HIBCC to Issue Unique Device Identifiers

GS1 and HIBCC have been named by FDA as two of the organizations able to assign Unique Device Identifiers (UDI). The UDI rule, issued in September 2013, requires the label of medical devices, including combination products that contain devices, to include a UDI. The labeler must submit product information concerning devices to FDA’s Global Unique […]

Revision of GMP “Orange Guide” Issued by MHRA

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released a revision of its GMP “Orange Guide” in January that incorporates the changes made to EU’s GMP Guide in the wake of the Falsified Medicines Directive (FMD). Included are new chapters regarding brokers of finished medicines and active substance manufacturers, distributors and brokers, along with […]

FMD Implementation in Europe Drives Better API Sourcing Knowledge and Interagency Communications

Implementation of Europe’s Falsified Medicines Directive (FMD) has shed important light on what the active pharmaceutical ingredient (API) part of the global pharmaceutical supply chain actually looks like and has led to enhanced communication between the countries that participate in it....

IPQ Monthly Update — May, 2013

The IPQ "Monthly Update" for May is now available. Read this story for a concise summary of its contents.

FDASIA Title VII Implementation Priorities and Action Plans Taking Shape

FDA has been sorting through the multi-faceted supply chain provisions of Title VII of the FDA Safety and Innovation Act (FDASIA) to identify which should be tackled first and to put action plans in place to implement them....

U.S. and Five Other Countries Await Listing Decision Under EU’s Falsified Medicines Directive

The U.S. is among six countries with applications pending at the European Commission (EC) to be listed as a third country with GMPs equivalent to those in force in the EU, which allows continued export of active pharmaceutical ingredients (APIs) into the EU without a company-specific certification under the terms of the EU’s Falsified Medicines […]
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