FDA office opens in China

The US Food and Drug Administration's office in Beijing was officially opened today (November 19).

This is the first overseas office set up by the FDA, which said it plans to also open offices in Shanhgai and Guangzhou that will serve as inspection stations. 

The Beijing headquarters will house eight FDA staff seconded from the US, along with five Chinese nationals, and will provide advice on quality standards and inspection training, as well as maintaining an inspection function.

Shao Mingli, Commissioner of the State Food and Drug Administration (SFDA), Mike Leavitt, US Secretary of Health and Human Services, FDA Commissioner Andrew von Eschenbach, and US Ambassador to China Clark Randt cut the ribbon at the opening ceremony.

"We're opening up a new era, not just new offices, " said Secretary Leavitt at the ceremony.

"By having a presence in other parts of the world, we can work more closely with manufacturers and other governments, better share best practices and further ensure that quality and safety are built into ... products at the point of manufacture."

Shao Mingli said in his speech that - along with economic globalisation - drug safety has become an issue that crosses the borders of individual countries.

"To ensure drug safety for the public and protect public health is the historic mission in front of the governments of all countries, and to enhance cooperation is the only choice," he said. 

The establishment of this office will become a platform to facilitate exchanges between the regulatory departments of U.S. and China, and make positive contributions to the bilateral cooperation in the field of food and drug supervision.

The opening of the new offices comes after a series of scandals involving Chinese products in the US and other world markets, including contaminated medicines, foods, and personal care products such as toothpaste.

China is at the top of the list of countries for products which have had import permission to the US refused.

The FDA has been taken to task about its inspections record in the wake of the heparin scandal, in which contaminated heparin active pharmaceutical ingredient (API) sourced from China found its way into medicines, sparking a worldwide recall.

Some critics have argued that the agency should carry out more inspections of overseas plants. Recently-published figures show that the FDA carried out 13 visits to Chinese production facilities, out of more than 700 sites in 2007. That compared with 24 to France, which has 162 drug manufacturing plants.