Pharmaceutical Business review

FDA to establish offices in China

This is an important step forward in the FDA’s plans to hire and place FDA staff in China over the next 18 months. In addition, the FDA will be hiring a total of five local Chinese nationals to work with the new FDA staff at the US Embassy in Beijing and the US Consulates General in Shanghai and Guangzhou.

Building the FDA’s capacity outside of the US is said to support the agency’s ‘Beyond our Borders’ initiative. The initiative facilitates the building of stronger cooperative relationships with the FDA’s counterpart agencies around the world and enhanced technical cooperation with foreign regulators. The permanent overseas offices in China will also allow greater access for inspections and greater interactions with manufacturers to help assure that products that are shipped to the US meet US standards for safety and manufacturing quality.

Murray Lumpkin, deputy commissioner for International and Special Programs, FDA, said: “Along with the important memoranda of agreement signed with two FDA counterpart Chinese agencies, our efforts to fill permanent FDA positions in China are a significant step toward ensuring access to safe food, drugs, and medical devices in the global market.”