China hopes to learn ins and outs of regulation from U.S. FDA

Print 29 April 2015
EJ Lane / FeircePharmaAsia

China's FDA is laying plans to work directly with its U.S. counterpart to learn the secrets of drug and medical-device regulation and bring China drugmaking and other regulated industries up to international standards.

Representatives of the two agencies just completed a visit to the U.S. FDA facilities, where they laid out a program of reforming China's regulatory procedures. The Washington, DC, visit was the first of the two agencies to work together throughout the year to instruct CFDA officials on how the U.S. FDA regulates food and drugs.

A total of 159 officials from both agencies held the initial information exchange, including professors from Peking and Nankai Universities and provincial drug and food regulators.

The meeting was sketched in a release by the CFDA.

As a backdrop, the U.S. FDA has complained repeatedly that China's visa system, which is slow to grant permits to work there despite a couple of agreements between the two countries going back two years, has stymied efforts on closer cooperation.

An FDA spokesman told the Wall Street Journal earlier this month that staffing in China usually fluctuates because of tours of duty assignments that require constant replacements. He said 6 members of the 10-person staff in the FDA's Beijing office received their visas only recently.

One possible solution the FDA is looking at, the spokesman said, is assigning inspectors for only two, three or 6 months, presumably to get around the visa problem.

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