The United States is now a “listed” country with the European Commission, so that U.S. pharmaceutical companies need not obtain an export certificate from the Food and Drug Administration before shipping certain 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 European Commission in January that the federal agency’s good manufacturing practices be considered at least equivalent to those in Europe.
The European Commission 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, FDA said.
“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 FDA Commissioner Margaret A. Hamburg in a 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.”
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.
Europe drops certificate for U.S. pharmaceutical shippers
