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. A pilot phase of the program will begin on Jan. 2.

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.

The agency has also warned consumers not to buy prescription medications over the Internet because the drugs may not contain the correct ingredients and could even be toxic.

U.S. and European agencies already cooperate in assessing whether studies adhere to "Good Clinical Practices" regulations. For a generic drug to be deemed equivalent to a branded medicine, bioequivalence tests are done to make sure they work the same way in the body, and it is those tests that are the focus of the new initiative.

Teva Pharmaceuticals Industries of Israel and Pennsylvania-based Mylan Inc are another two of the world's largest producers of generic drugs.