FDA, European regulators to cooperate on generic drugs

By Reuters Staff U.S. and European drug regulators will work together on joint inspections around the world to try to make sure consumers are buying generic medications that are both safe and effective, the U.S. Food and Drug Administration said on Wednesday. The European Medicines Agency and France, Germany, Italy, the Netherlands and the United Kingdom are taking part in the initiative, which will focus on the testing stage that precedes generic drug applications. They will cooperate on inspecting facilities used in clinical trials and assess the acceptability or reliability of data obtained in the trials. The FDA last year settled an ongoing legal battle over questionable manufacturing practices and other issues at several manufacturing facilities operated by Ranbaxy Laboratories Ltd, a global producer of generic drugs and India’s largest pharmaceutical company.