FDA officially opens its doors in China
The FDA’s main office will be in Beijing, with the Shanghai and Guangzhou locations serving as inspection stations. This is part of a major plan by the agency to expand its international presence, with additional branches due to open in Europe, Latin America and India before the end of the year.
The Beijing office was opened in a formal ceremony last week attended by US Secretary of Health and Human Services Michael Leavitt, FDA Commissioner Andrew von Eschenbach, and Shao Mingli, China’s deputy health minister and head of the State Food and Drug Administration (SFDA).
"We're opening up a new era, not just new offices, " Secretary Leavitt said.
"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."
The opening of the new offices is timely, coming at the tail end of 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 also at the top of the list of countries for products which have had import permission to the US refused.
With a headcount of just eight, plus five Chinese nationals, the FDA’s presence in China is considered mainly advisory, providing advice on US quality standards and training local inspectors, although it will also maintain an inspection function.
That said, a permanent FDA presence in China will help the agency to “address the challenges presented by globalisation, " said von Eschenbach. In particular it would allow the FDA to respond more quickly to any problems that occur.
The FDA has been under fire from US politicians in recent weeks, with questions raised about the agency’s oversight of the pharmaceutical supply chain in the wake of the heparin scandal, which saw product from around the world recalled after contaminated heparin sourced from China found its way into medicines, the ongoing probe into quality standards at India’s Ranbaxy and slew of food safety incidents.
One of the persistent criticisms is that the agency should do more inspections of overseas plants. 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.
Meanwhile, the European Union and China are also looking at working more closely in the future. The SFDA is planning to send a delegation to the EU next year to meet with regulators and industry groups.
The visits had been planned to take place in 2008, but were held back after the massive governmental budget drain which came about as a result of the earthquake in Chengdu earlier this year.
