China Orders New Oversight of Heparin, With Tainted Batches Tied to U.S. Deaths

China officially investigates on the Heparin case, but it takes a defensive tone by saying the U.S. imported Heparin is from a China-U.S. joint venture company. From The New York Times:

China’s top drug safety agency has ordered its local bureaus to increase supervision over the production of heparin, a blood-thinning drug that has been linked to at least 19 deaths and hundreds of allergic reactions in the United States, China’s state-run news agency reported Friday.

The drug agency, the State Food and Drug Administration, said producers of the active ingredient in heparin must now obtain their raw material from registered suppliers, and it ordered the suppliers to strengthen their checks on the quality and safety of those raw ingredients.

The announcement, just hours after American officials said they had identified a contaminant in heparin from China, represents a turnabout for Chinese drug regulators. Previously, they had said they did not have oversight of large parts of the industry, and they had called on importing countries to take responsibility for ensuring heparin’s safety. China is the world’s largest supplier of the active ingredient in heparin.

Read also the Wall Street Journal’s report: In a Reversal, China to Up Regulation of Heparin Production

China’s State Food and Drug Agency has posted a notice requiring heparin producers to get the raw chemicals used to make the drug from registered suppliers. And the suppliers will be required to improve their tests on their products, the AP reports this morning.

“The Ministry of Commerce is highly concerned about this issue,” said a statement posted on the ministry’s Web site, Bloomberg reports. “The ministry will continue to work with the State Food and Drug Administration and other agencies to carry out relevant work.”

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