China Signs Agreement to Improve Drug and Food Drug Exports

December 20, 2007
Angie Drakulich

Angie Drakulich was editorial director of Pharmaceutical Technology.

ePT--the Electronic Newsletter of Pharmaceutical Technology

After a negative year in the news, China has finally agreed to improve the safety of its drug and food exports, according to the US Department of Health and Human Services.

Washington, DC (Dec. 11)-After a negative year in the news, China has finally agreed to improve the safety of its drug and food exports, according to the US Department of Health and Human Services (HHS).

Li Changjiang, minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People’s Republic of China, and HHS Secretary Mike Leavitt signed two Memoranda of Agreement (MoA) on Dec. 11 in Beijing, just before the third session of the US–China Strategic Economic Dialogue began. The first MoA focuses on food and feed, the second on drugs and medical devices.

“Taken together, these agreements will enhance the safety of scores of household items the American people consume on a daily basis,” said Leavitt.

The agreement has three major components:

  • To promote information-sharing, all Chinese producers will register with Chinese authorities, who will then share the information with US regulators. In this context, China’s State Food and Drug Administration (SFDA) will inform US authorities if a Chinese facility fails inspection or loses certification, and US Food and Drug Administration officials will gain more access to Chinese production facilities.

  • To ensure safety, Chinese regulators will certify that food and feed covered by the agreement meets FDA standards.

  • To ensure compliance, the Chinese companies will adopt quality-assurance methods (e.g., electronic tracking systems for products).

According to Leavitt, the US will import $2 trillion worth of goods from 825,000 importers in 2008. “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 borders,” he said.

Leavitt submitted an Action Plan on Import Safety to President George W. Bush in November outlining this new approach, which is supported by the MoA. The plan was part of Leavitt’s work as chair of the Import Safety group, initiated last summer by Bush.

Chinese and US representatives began work on the MoA during the second session of the US-China Strategic Economic dialogue last May. The dialogue began this time last year to ensure “that citizens of both countries benefit equitably from our growing economic relationship and that we work together to address economic challenges and opportunities,” according to Bush’s statement on the initiative. The dialogue has been overcast by several reports of contaminated “made in China” products, including pet food, toothpaste, juice, and fish, throughout the world.

The MoA, however, promise to bring “concrete, measurable results” toward alleviating, and fielding off, this problem, said Leavitt.

To read the full US–China agreements, click here: