U.S., EU on collision course over API rules
When two powers play the game of chicken, the question is which will yield first. The U.S. and the EU appear to be on a collision course in the modern version of that test of wills, but it is drugmakers and U.S. API makers that look like they might get hit by the flying debris.
Come July 2, all active pharmaceutical ingredients imported into Europe must be certified that they meet EU regulations by the country of their origin. That is, unless the EU has exempted its association of countries because it has determined its regulators are on top of their manufacturing. The U.S. asked for that exemption in January, but it took Europe 7 months to grant just one, which Switzerland received. Now U.S. API makers are panicking that they will lose their business, in-PharmaTechnologist reports.
U.S. companies are getting "frantic," John DiLoreto, executive director of the bulk pharmaceuticals task force for the Society of Chemical Manufacturers and Affiliates (SOCMA), tells the publication. DiLoreto said it is clear that the EU does not intend to yield on its implementation timetable, and it is clear the FDA will not be issuing certifications. The FDA did not comment.
Originally, there was more concern whether some of the key suppliers like China and India would be able to meet the timeline. Now it is a question of whether the U.S. and EU can get around the current impasse. DiLoreto tells in-PharmaTechnologist that it is unlikely European API makers could meet all of the demands, leaving drugmakers there up in the air as well. "If you've only got a couple of countries that will provide individual certificates, and only a couple with an exception in place, where are they going to get their product from? All in the EU? It's doubtful."
- read the in-PharmaTechnologist story