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IPQ Inside the global regulatory dialogue

European Trade Associations Step Up to the Plate on Drug Counterfeiting

May 27th, 2010

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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.

In May of this year, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) published a document titled “Ten Principles on Counterfeit Medicines” to “re-focus attention on this issue and underline the R&D-based pharmaceutical industry’s stance in the global fight against counterfeit medicines.”

According to IFPMA, this document was written in part due to the continued rise in the incidence of counterfeit medicines and the resulting public health concerns.

Protecting patient health was also the focus of a recent pilot program carried out in Sweden by the European Federation of Pharmaceutical Industries and Associations (EFPIA) between September 2009 and January 2010.   The pilot involved creation and use of a system for tracing and verification of drugs in the legitimate supply chain from manufacturers and wholesalers through pharmacy retailers.  EFPIA released an analysis and final report on the pilot in April.  (More detail and links to the IFPMA and EFPIA documents are provided in the full story available to subscribers).

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[Editor’s Note:  The June issue of IPQ will provide an in-depth report on the changing inspection and GMP enforcement landscape in the US, EU, and globally.]

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