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More Biotechnology news
U.S., Europe, Australia to expand drug inspections


ASSOCIATED PRESS

8:20 a.m. July 9, 2008

WASHINGTON – Faced with the globalization of drug production, the United States is joining with Europe and Australia to inspect factories in China and India that make raw materials for medications.

Bush administration officials said Wednesday the agreement will allow regulators to cover a wider territory and inspect more plants.

“What we are seeing is the maturing of a global market and we have to invent new tools to deal with a changing environment,” Health and Human Services Secretary Michael Leavitt said.

The pilot program will concentrate first on facilities in China and India.

The reach of U.S. inspectors took on new focus last spring after the blood thinner heparin – made with Chinese ingredients – was linked to dozens of deaths and hundreds of allergic reactions. The drug has been recalled by Baxter International and the U.S. has blocked imports from the Chinese company.

The Food and Drug Administration found the drug was contaminated with oversulfated chondroitin sulfate, which mimics heparin and thus was not detected in routine testing.

The FDA wants to establish foreign offices in three Chinese locations – Beijing, Shanghai and Guangzhou. Thirteen employees would be assigned to work there.

The program announced Wednesday with Europe and Australia would give FDA the option of going into a facility that already has been inspected by another country's inspectors.


 On the Net:
Health and Human Services Department: www.hhs.gov/
Food and Drug Administration: www.fda.gov/








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