China's drug agency says importing countries must ensure product safety

China's drug safety agency, commenting on a probe into the recalled drug heparin, said it enforces strict controls on chemicals used in pharmaceuticals, but that importing countries are ultimately responsible for ensuring product safety.

The State Food and Drug Administration, in a statement on its Web site, said it was cooperating with a U.S. probe into a factory that makes heparin, a blood-thinning drug by Baxter International that is subject to a massive recall due to adverse patient reactions.

"We attach high importance to this," the agency said in its first comment on the heparin recall. SFDA officials have not responded to repeated inquiries about the case.

But the SFDA said that based on international practice, "safeguarding the legality, safety and quality of raw materials imported for use in pharmaceuticals is the responsibility of the importing country."

Deerfield, Illinois-based Baxter recalled thousands of vials of the blood thinner and halted production earlier this month after it was linked to four deaths and hundreds of allergic reactions.

So far, the cause of the adverse reactions remains unclear.

The U.S. Food and Drug Administration is conducting inspections at a Baxter facility in New Jersey, at company supplier Scientific Protein Laboratories of Wisconsin and at Changzhou SPL, a factory in the eastern Chinese city of Changzhou that is 55 percent owned by Scientific Protein Laboratories.

China's SFDA said it also was investigating the factory, but gave no details.

The heparin scare is the first big issue to arise since Washington and Beijing signed an agreement in December that was meant to improve coordination on food and drug safety following a spate of scandals over tainted or substandard products.

FDA officials say cooperation has improved.

But the heparin case highlights the difficulties both sides face in improving oversight given paltry levels of staffing and funding on both sides. The FDA acknowledged that Changzhou SPL was never inspected by the FDA, contrary to its own regulations, due to what it says was a mix-up with names.

The Chinese food and drug agency apparently did not inspect the factory because it was classified as a chemicals manufacturer, not a pharmaceuticals company.

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On the Net:

FDA: http://www.fda.gov/

Baxter International: http://www.baxter.com