US FDA does not need to issue Written Confirmations by 2 July 2013

Recommendation

6/7 September 2022

Drug Master File Procedures in the EU, the US and Japan - Live Online Training
Taking into account the guidance on metal impurities (ICH Q3D) and genotoxic impurities (ICH M7)

In a Press Release the US FDA 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. 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.

The European Commssion published the implementing decision on the Webpage.