China continues to dominate US regulatory agenda

Richard Clarke

July 21, 2008

2 Min Read
China continues to dominate US regulatory agenda

Agreement will see three FDA offices established in Chinese territory by end of year

United States China remains top of mind for US regulators, who are stepping up efforts to improve the safety of food and drug products exported from the country into America.

The Food and Drug Administration is understood to have received the go-ahead from the Chinese authorities to establish inspection offices in three cities — Beijing, Shanghai and Guangzhou — before the end of the year, with a staff of nine to 12 people between them.

According to Reuters, department of health and human services secretary Mike Leavitt said at a briefing during high-level US-China economic talks that the initiative was not just about ensuring the safety of Chinese products sold on the US market, but also about helping China improve its safety record overall.

"We are working very closely with the government to create a new strategy on the way we deal with imports," he said. "We see this office not just necessarily as an inspection group. It will be a capacity-building group."

News of the offices follows the signing of a memorandum of agreement on food and feed safety, agreed by both countries in December of last year.

Leavitt has also signed a memorandum of understanding with Chinese vice minister of health Wang Guoqiang that will see scientists in the US and China collaborate on research into integrative and traditional Chinese medicine.

"This project will advance our understanding of when and how to appropriately integrate traditional Chinese medicine with Western medical approaches," said Leavitt.

The spotlight has been on Chinese products following a string of incidents that have shaken confidence in products from China.

Most recently, a consignment of heparin, the blood-thinning drug, from China was discovered to have been contaminated with over-sulphated dermatan chondroitin. The tainted drug has been blamed for scores of deaths in America.

The climate of fear is providing a new avenue of business for some companies, such as US consultancy Aim & Act, which has launched a service designed to help Chinese companies market safe dietary supplements on the American market.

Andrew Buirge, president of consulting for the Montana-based firm, said: "In less than one week, most manufacturing processes can complete a quality-assurance audit. This detailed examination of each step in a manufacturing process identifies any problem areas and reduces the possibility of contaminations to virtually none."

It's not just China in the FDA's sights: the agency is also now planning inspection offices in India. The agency plans to open sites in Mumbai and New Delhi by early 2009 at the latest, reported Reuters.

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