The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration announced today 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.
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 of the FDA’s regulatory and inspectional oversight of APIs. The audit took place from May 13 - 20, 2013.
For more please visit: Waiver
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