The U.S. is now a “listed” country with the European Commission, meaning U.S. companies do not need to obtain an export certificate from the U.S. Food and Drug Administration before shipping certain pharmaceutical products to Europe, according to the FDA.
Without the waiver, all U.S. shipping companies shipping active pharmaceutical ingredients to Europe after July 1, 2013, would have had to submit documentation from the FDA showing that the product was manufactured in accordance with Europe’s manufacturing practices. To avoid that situation, the FDA filed a formal “listing request” with the EC in January 2013 to ask that the FDA’s good manufacturing practices be considered at least equivalent to those in Europe.
The EC has now approved that request following an audit of the FDA’s regulatory and inspectional oversight of APIs.
“Working with the EC, the FDA has helped U.S. pharmaceutical companies avoid duplicative administrative efforts which impede trade and delay the manufacture of needed medicines,” said Margaret A. Hamburg, FDA Commissioner, in a written statement. “At the same time, the FDA applauds Europe for taking steps to protect its pharmaceutical supply chain and will continue to collaborate with its regulatory counterparts around the world to help keep our own supply chain safe.”