US companies no longer need an export certificate from the FDA before shipping certain medicines to Europe
The US is now a ‘listed’ country with the European Commission (EC), which means that US companies do not need to obtain an export certificate from the US Food and Drug Administration (FDA) before shipping certain pharmaceutical products to Europe.
Without the waiver, all US companies shipping active pharmaceutical ingredients (APIs) to Europe after 1 July would have had to submit documentation from the FDA showing that the product was manufactured in accordance with Europe’s manufacturing practices.
To avoid that process, the FDA filed a formal ‘listing request’ with the EC in January to request that the FDA’s good manufacturing practices be considered at least equivalent to those in Europe.
The EC has now approved that request following an audit of the FDA’s regulatory and inspectional oversight of APIs, which took place from 13–20 May.
‘Working with the EC, the FDA has helped US pharmaceutical companies avoid duplicating administrative efforts which impede trade and delay the manufacture of needed medicines,’ said FDA Commissioner Margaret Hamburg.
The FDA applauds Europe for taking steps to protect its pharmaceutical supply chain
‘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.’
The Bulk Pharmaceuticals Task Force (BPTF) of the US Society of Chemical Manufacturers and Affiliates (SOCMA) also welcomed the announcement.
‘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,’ said John DiLoreto, Executive Director of BPTF.
The BPTF said it supports negotiations between the US and the EU to eliminate trade barriers, to promote greater global harmonisation of current Good Manufacturing Practices (GMP) requirements and to improve the safety of drugs throughout the supply chain.
‘We hope FDA and EU officials will continue to attain the maximum achievable level of information sharing and greater harmonisation on implementation of GMPs throughout the drug supply chain,’ DiLoreto added.