Waiver from European Commission to help exporting for US pharmaceutical manufacturers

The US Food and Drug Administration announced on Friday (June 21) that the USA is now a “listed country” the European Commission (EC) so that US companies need not obtain an export certificate from the FDA before shipping certain pharmaceutical products to Europe.

Without the waiver, all US 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 (GMP).

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 last month of the FDA’s regulatory and inspectional oversight of active pharmaceutical ingredients (APIs).