Processing Magazine

U.S. pharmaceutical companies granted easier access to EU market

June 25, 2013
Pharmaceutical processing
The FDA is working to facilitate exports for all U.S. pharmaceutical companies through avoidance of duplicate administrative procedures. (iStockphoto/Thinkstock) 

The United States is now considered a "listed country" by the European Commission, which means that U.S. companies don’t need an FDA export certificate before shipping certain pharmaceutical products to the European Union.

The move is expected to facilitate exports for pharmaceutical businesses based in the United States.

According to a statement by the Food and Drug Administration, the waiver comes into effect from July 1st, 2013. Without it, all U.S. companies exporting active pharmaceutical ingredients to the European Union have to submit documents to the FDA first, proving that the product was manufactured according to Europe's good manufacturing practices (GMP). If the products are approved, the FDA provides the manufacturer with an export certificate.

In a bid to reduce the administrative burden for American companies and promote growth overseas, the FDA submitted a formal "listing request" to the European Commission early this year. The request asked that the European Commission deem the FDA's GMP to be equivalent to those in Europe and thus relieve exporting procedures.

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The European Commission agreed to approve the request, after carrying out a detailed audit of the FDA's regulatory practices and inspection oversight of active pharmaceutical ingredients. The audit took place between May 13 and May 20, 2013.

According to FDA commissioner Margaret A. Hamburg, working together with the European Commission has allowed the FDA to facilitate exports for all U.S. pharmaceutical companies by avoiding duplicate administrative procedures that could hinder international trade and delay the production of active pharmaceutical ingredients and much needed medicines.

The FDA welcomed the efforts of the European Commission to take measures to protect its pharmaceutical supply chain, Hamburg added. The FDA will continue to work together with its counterparts across the globe to ensure that the U.S. supply chain is just as safe, she concluded.

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Previously, the European Commission has granted listed-country status to Switzerland, Japan and Australia. In an effort to protect European consumers the European Commission enacted the Falsified Medicines Directive in 2011, under which the import of APIs falls.

In its announcement, the FDA stated that over the past few years the agency has been working on its transformation from a predominantly domestically-focused entity into a proactive, global public health agency, aiming to carry out its mission in a more effective way in a world where trade and product safety have no borders.