FDA, European regulators to cooperate on generic drugs

Wed Dec 18, 2013 3:38pm EST

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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 January 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.

(Editing by Andrew Hay)

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