FDAnews Drug Daily Bulletin

China Requires Heparin Makers to Get Raw Material From Registered Suppliers

March 25, 2008

China’s Ministry of Commerce is requiring local heparin makers to increase testing of raw materials, improve postsale tracking and ensure their raw material comes from registered suppliers.

The requirement follows U.S. congressional inquiries into the FDA’s overseas inspection process in the wake of Baxter’s recall of contaminated heparin products originating in China. The House Oversight and Investigations Subcommittee scheduled a hearing for April 15 on the distribution of contaminated heparin. A follow-up hearing is scheduled for April 22 during which the committee expects to ask FDA Commissioner Andrew von Eschenbach how the agency will address concerns regarding its efforts to inspect foreign drug facilities.

Adding to the FDA’s difficulties: Some heparin-producing plants are not registered as drugmakers. The factory where the suspect raw heparin was made is classified as a chemical plant, China’s official Xinhua News Agency reported earlier this month.

The U.S. and Chinese actions are part of expanding international efforts to ensure the safety of heparin. Other nations testing their heparin supplies include Australia, Canada, Germany and Switzerland.