US FDA does not need to issue Written Confirmations by 2 July 2013
![Drug Master File Procedures in the EU, the US and Japan - Live Online Training](files/eca/userImages/training.img/Z-ECA-Drug-Master-File-Procedures-LOT.jpg)
Recommendation
17/18 September 2024
With updates on the CEP 2.0!
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.
Related GMP News
26.06.202410 points on how the FDA's CDER monitors the Quality of Medicinal Products
08.05.2024EMA Plans for the next three Years
30.04.2024Lean GMP: is "right-sizing" GMP and Compliance possible?
24.04.2024Unexpected Deviations: the Role of the QP
10.04.2024FDA's current Thinking on KPIs and Quality Metrics
21.02.2024What is the African Medicines Agency?