Real World Evidence Evidence & Data Partnerships

Oct 14, 2014 - Oct 15, 2014, Bethesda

This year real patient data will change healthcare.

FDA/EC Agreement Allows a More Efficient, Safer US-EU Drug Supply

US pharmaceutical companies can now export certain pharmaceutical products to the EU without additional documentation, as the U.S. is granted status as a ‘listed’ country by the European Commission.



Earlier this year, the FDA filed a formal ‘listing request’ with the EC so that their Good Manufacturing Practices could be seen as equal. The EC has now approved this request after having a detailed audit of the FDA’s regulatory and inspectional practices related to importing active pharmaceutical ingredients (APIs).

Currently, Europe regulates the import of APIs through its 2011 Falsified Medicines Directive which aims to maintain the safety of pharmaceutical products on a supply chain as several drugs continue to be sourced from various parts of the world.

Without this waiver, all drug manufacturers in the US who export APIs to Europe after July 1, 2013 would have to initially submit paperwork from the FDA, which demonstrates that their product was manufactured in line with Europe’s Good Manufacturing Practice (GMP). This development also means that medicines from the US could reach patients in the EU at a quicker, more efficient rate.

FDA Commissioner Margaret Hamburg praised this advancement saying, “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.”

Apart from the FDA, this development was also celebrated by the Bulk Pharmaceuticals Task Force (BPTF), who is part of the Society of Chemical Manufacturers and Affiliates (SOCMA).

Executive director of the BPTF, John DiLoreto, believes that this change will allow the continued safe supply of drugs from the US into the EU. He said, “We are pleased that US drug manufacturers will not be required to provide written confirmation of quality for the exportation of active pharmaceutical ingredients into the EU.”

“We hope FDA and EU officials will continue to attain the maximum achievable level of information sharing and greater harmonization on implementation of GMPs throughout the drug supply chain.”


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Real World Evidence Evidence & Data Partnerships

Oct 14, 2014 - Oct 15, 2014, Bethesda

This year real patient data will change healthcare.