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FDA Obtains Waiver From the European Commission to Facilitate Export For U.S. Pharmaceutical Manufacturers


The FDA has announced that the U.S. is now a “listed” country with the European Commission (EC) so that U.S. companies need not obtain an export certificate from the FDA before shipping certain pharmaceutical products to Europe. Without the waiver, all U.S. companies shipping active pharmaceutical ingredients (APIs) to Europe after July 1, 2013 would have had to first submit documentation from the FDA that the product was manufactured in accordance with Europe’s good manufacturing practices.


To avoid that burden for companies, the FDA filed a formal “listing request” with the EC in January 2013 that the FDA’s good manufacturing practices be considered at least equivalent to those in Europe. The EC has now approved that request following a comprehensive audit of the FDA’s regulatory and inspectional oversight of APIs. The audit took place from May 13 – 20, 2013.


Europe’s requirement for the import of APIs falls under its Falsified Medicines Directive, enacted in 2011 in response to the challenges posed in keeping the pharmaceutical supply chain safe at a time when products are increasingly sourced from around the world. Protecting consumers around the globe from falsified medicines is an enormous and complex undertaking that requires international cooperation. Over the past several years, the FDA has been transforming from a domestically-focused agency to a proactive, global public health agency in order to carry out our mission more effectively in a world where trade, and product safety and quality, have no borders.


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