Europe grants automatic import approval to many FDA-approved drugs
European regulators have approved an FDA request for a waiver allowing active pharmaceutical ingredients to be shipped to Europe without an export certificate.
The European Commission (EC) has agreed that the FDA’s good manufacturing practices be considered “at least equivalent” to those in Europe, according to an FDA press release.
“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,” FDA Commissioner Margaret A. Hamburg, MD, said in a press release.
The agreement followed an EC audit in May of how the FDA regulates and inspects production of active pharmaceutical ingredients (APIs).
Without the authorization, U.S. companies shipping APIs to Europe after July 1 would have been required to submit FDA documentation confirming that the products met Europe’s good manufacturing regulations.