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FDA and European regulators to cooperate on generics inspections

Source: Reuters - Wed, 18 Dec 2013 03:20 PM
Author: Reuters
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Dec 18 (Reuters) - 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 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, so-called 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 two of the world's largest producers of generic drugs.

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