FDA opens new China office in Beijing yesterday

Ajit Basrur

According to (broken link removed) -

The U.S. Food and Drug Administration opened an office Wednesday in China's capital — its first outside the United States — as part of a new global strategy to ensure the safety of trillions of dollars of imports.

Product safety has become a key issue as American manufacturers shift operations overseas and foreign producers make inroads in the U.S.

Worries about the quality of Chinese exports to America have become a major feature of bilateral trade ties, with substandard Chinese food and toxin-laced toothpaste among product safety scares this past year.

"In the past we have always been at our borders to try and catch things that were not safe or did not meet our standards," U.S. Health and Human Services Secretary Mike Leavitt said at a ribbon-cutting ceremony to mark the opening of the Beijing office. "In the future our new strategy is to build safety into products at every step of the way."

After meetings with Chinese officials on Tuesday, Leavitt said both countries would work on a joint initiative to use better technology for detecting contamination, demand greater corporate responsibility and increase sharing of data and information.

Health minister Chen Zhu has said that Chinese quality officials will soon be stationed in the U.S.

In the past year, China has stepped up inspections and tightened restrictions on food production and other industries, after a series of global product scandals. Still, it's an uphill climb for Chinese authorities to regulate countless small and illegally run operations, which are often blamed for introducing chemicals and food additives into the murky food chain.

Most recently, dairy products tainted with the industrial chemical melamine have been blamed in the deaths of at least three babies in China. Tens of thousands of other children were sickened.

Shao Mingli, a vice health minister and head of the country's food and drug administration, said the opening of the FDA office "provides a very clear signal to the whole world."

"As food and drug regulatory agencies, our first priority is to protect public health and life," Shao said. "This is our top responsibility."

The FDA office in Beijing will be followed by two more in the Chinese cities of Shanghai and Guangzhou. Offices will also be opened in India, Latin America and Europe in coming months as the FDA tries to globalize its presence to reassure consumers. This year alone, the U.S. imported $2 trillion worth of goods, equal to four times the size of Brazil's economy

Bob the QE

Having been to and worked in China and worked with in the culture and communities I have to question how effective this will be. I am comforted by the fact that the FDA has taken this action but I still have concerns as to the effectiveness of such a set-up. I will be interested in how exactly the inspection, quarantines and recalls will work. I noticed you mentioned the amount of imports from China however I did not see what percent of this will be under the FDA, any idea? Does any one in this forum have an idea what type of products the US will be receiving under the FDA controls and how consumers would know. As we all know if we want to see approximately where our products we purchase was produced there is a tag or label, how will this work with food and drugs?

Thanks for the information.


As a employee of an American-owned company in China (not a Chinese-owned company managed by an American) that manufacturers sterile, single use medical devices totally in China and exports them ready for commercial distribution in the US, I can say that this move by the FDA is a welcome event. Our Chinese company is FDA registered, holds 510(k)s, is ISO certificed and has CE Mark certification.

We look forward to the day when all medical device companies in China have to comply with the same level of regulator oversight.

Bob the QE

I am glad to hear from someone on that side of the ocean who works in that industry. I am not going to pick a fight over this but do not let that ISO cert on the wall influence anything. I know from personnal experience working in the manufacturing environment in the Shenzhen area that ISO means very little in China. Case in point, on one audit I had over 8 major (using major/minor as a classification) and 22 minor findings sever enough in nature that we pulled business and put other business on hold. Here is the clincher they had just passed there registration audit 3 months prior to my visit. When the closing meeting was held they were quite upset with the fact that these findings (sound in fact) were not turned up by the registration audit. This was the worst case I have seen but not unusual I am sorry to say. In my industry it was more of who the owner was and how much they wanted to pay for the cert. It was sad. I am glad to hear a positive side to it. Good luck
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