The USA is now a “listed country” with the European Commission. This means that American companies do not need to get an export certificate from the FDA (Food and Drug Administration) before delivering certain pharmaceutical products to the European Union.

The waiver comes into effect from July 1st, 2013. Without it, all US companies shipping APIs (active pharmaceutical ingredients) to the European Union have to submit documentation to the FDA first, showing that the product was manufactured according to Europe’s GMP (good manufacturing practices). On approval, the FDA provides an export certificate.

To reduce that burden for American companies, the FDA submitted a formal “listing request” with the European Commission at the beginning of this year. The request asked that the European Commission consider the FDA’s GMP to be at least equivalent to those in Europe.

After carrying out a comprehensive audit of the FDA’s regulatory and inspectional oversight of active pharmaceutical ingredients, the EC has approved the request. The FDA was audited from May 13th to 20th, 2013.

FDA Commissioner Margaret A. Hamburg, M.D., said:

“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. At the same time, the FDA applauds Europe for taking steps to protect its pharmaceutical supply chain and will continue to collaborate with its regulatory counterparts around the world to help keep our own supply chain safe.”

As pharmaceutical products are increasingly sourced from all over the globe, the EC wanted to tighten up on the quality control of API imports. So, it enacted The Falsified Medicines Directive in 2011, under which the import of APIs falls.

Protecting consumers worldwide from counterfeit medications is a huge and complex task which cannot be done without international cooperation.

In an online communiqué, the FDA wrote “Over the past several years, the FDA has been transforming from a domestically-focused agency to a proactive, global public health agency in order to carry out our mission more effectively in a world where trade, and product safety and quality, have no borders.”

The European Commission has granted export waivers to the following “listed countries”:

  • Switzerland
  • Japan
  • Australia
  • The United States of America

Written by Christian Nordqvist