Pact aims to ensure safety of Chinese drug imports

Popular drugs made in China are targeted in a new system for inspecting and certifying manufacturers.

By Susan J. Landers — Posted Jan. 21, 2008

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Assuring the safety of medical products imported from China, including certain antibiotics and a popular statin, is the goal of a new agreement signed in Beijing by Health and Human Services Secretary Mike Leavitt and the head of China's State Food and Drug Administration.

The two nations are embarking on a plan to build safety into importation from the start, Leavitt said in a Dec. 19, 2007, speech at the National Press Club in Washington, D.C. "We can't inspect everything," he noted. "We need to know who to trust."

President George W. Bush appointed Leavitt to head a Working Group on Import Safety. This panel was established to determine controls to put into place to stem the tide of harmful goods in an era of global trade.

Two new agreements were unveiled Dec. 11. One covers imported drugs and medical devices. The other focuses on food. Both were developed after a number of dangerously tainted products, including toothpaste and pet food as well as toys coated with lead paint, made their way last year from China into American homes.

"To keep up with the pace of global commerce, we need a fundamental shift, from trying to catch unsafe products as they come in, to building quality and safety into products before they reach our border," Leavitt said in announcing the agreements.

The pact on imported drugs and medical devices covers the following items manufactured in China for export to the U.S.: gentamicin sulfate, atorvastatin, sildenafil, dietary supplements intended to remedy erectile dysfunction, human growth hormone, oseltamivir, cephalosporins, glycerin, glucose test strips and condoms.

The agreement calls for all Chinese producers of these drugs and devices to register with their government. A certification program is planned to ensure that the imported items meet standards set in the United States.

The two countries also will conduct joint training programs and activities to cover inspection methods, clinical trials and the development of technical guidance documents, laws and regulations, according to the agreements. "We want the Chinese to have access to our markets, but they must meet our standards," Leavitt said.

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