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 Directive (FMD).

As part of the EU’s effort to ensure the quality of imported APIs, after the beginning of July, API manufacturers must get written confirmation from their domestic regulatory authority that they are in compliance with EU GMPs, if their country does not have the “third country” equivalency designation, before the EU will grant entry of their product.

As of late March, the EC website indicates that only Switzerland has been approved.  The other applicants are in the process of being assessed (see box below right).

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In a late-January press release, FDA states that its request “sends a clear and strong message that recognition of equivalent scientifically-based standards better protects the public and provides a greater level of protection for more people.”

“Working with the EU under this Directive is evidence of the FDA’s commitment: (1) to meet the challenges of globalization, (2) to rely on our trusted partners in other countries, and (3) to better use our resources where there is greatest risk. In addition, United States exporters of APIs benefit greatly from FDA’s listing request. If the FDA’s listing request is approved, exporters will avoid duplicative administrative efforts, which could impede trade and delay the manufacture of needed medicines.”

The FMD was approved by the European Parliament in February 2011, and is aimed at “protecting patients against the rising threat of falsified medicines” (IPQ “The News in Depth” May 31, 2011).  It is one of three prongs of a broad-based EU legislative effort known as the “Pharmaceutical Package.”  Also part of this package is legislation to: ● strengthen the EU’s pharmacovigilance effort, and ● better regulate the way health information is supplied to the general public.