SHANGHAI - The US Food and Drug Administration (FDA) aims to have more in-depth cooperation with Chinese food and drug manufacturers, as it prepares for the global launch of its new IT risk-based screening system.

"In order to ensure food and drug safety in the US, we have to collaborate with more countries like China," said Dara Corrigan, associate commissioner for Regulatory Affairs of the FDA, on her first visit to Shanghai on Tuesday.

Corrigan and her team in the US are currently testing the new system, which will gather information about the source of drugs coming into the US and make the online system available for the whole industry to see whether the drugs pose any safety risks.

"It could help us to identify the risks better and also convince people about the value of good information, which is the tremendous potential the system will have," said Corrigan.

The new system will expedite the clearance of lower-risk cargo, but only if accurate and complete data is provided by importers and entry filers.

"We have to make a large step to integrate such information in terms of communicating with regulators and manufacturers in the industry from different countries, especially China, to make it really work," said Corrigan.

The FDA's Office of Regulatory Affairs, which has 4,400 employees, inspects regulated products and manufacturers, analyzes samples of regulated products, reviews imported products offered for entry into the US and responds to public health emergencies.

The FDA has conducted inspections of Chinese facilities for several decades, but its cooperation with China entered a new stage in 2009 when it posted inspectors in the country on a full-time basis.

Launched in 2008, the China office of the FDA in Beijing aims to strengthen the safety, quality and effectiveness of food and medical products produced in the country for export to the US.

"We've carried out inspections with the help of the central government at 80 local drug companies in China last year to ensure the safety of products exported to the US, which will continue as a regular task for us," said Christopher J. Hickey, FDA country director in China.

During her stay in Shanghai, Corrigan visited a plant producing drug products for export to the US and discussed the importance of safe drug products with Chinese regulators and drug manufacturers.

China Daily

(China Daily 11/02/2011 page11)