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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.
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