EU says U.S. companies can ship APIs without export certificate

FDA said the European Commission approved a request from the agency to consider FDA's GMPs as at least equivalent to those in Europe. The decision means U.S. companies will be able to ship APIs to Europe after July 1 without written confirmation from FDA in the form of an export certificate that GMPs comply with those in the EU. Companies in Australia, Japan and Switzerland also will be able to ship APIs to Europe without written confirmation from their regulators. ...