The FDA's "Beyond our Borders" initiative has taken a major step forward. The initiative (for establishing on-ground FDA posts in Asia, Europe, Latin America, and the Middle East) has been approved by the State Department to create eight positions within the People's Republic of China. Authorization from the People's Republic is still in process. FDA staff will be hired and placed within China over the next year and a half, and Chinese nationals will also be hired to collaborate with staff at U.S. embassies and consulates.

The FDA created the Beyond our Borders initiative to address concerns about overseas food and drug production, such as the recent problems with the drug Heparin that contained an active pharmaceutical ingredient from China. The posts are intended to improve inspections and interactions with manufacturers. In addition, the permanent offices will facilitate cooperation with the foreign counterparts to the FDA, and enable better exchange of information.

Murray M. Lumpkin, M.D., FDA deputy commissioner for International and Special Programs commented that the China program would bring a benefit to the global market of safer food, drugs, and medical devices. Lumpkin acknowledged that a global economy requires more efficient regulation and information exchange regarding product quality.

In December of last year, the FDA and the State Food and Drug Administration of the People's Republic of China signed Memoranda of Agreements that set out measures and deadlines to enhance the safety of products manufactured in China and sold in the U.S., including food, drugs, and devices. Under the Memoranda, Chinese producers will register with Chinese Authorities, and the Chinese authorities will share data with the U.S. Department of Health and Human Services and will certify that the products meet U.S. standards.

FDA Commissioner Andrew C. von Eschenbach, M.D. recently testified to the Senate Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, on the need to improve safety of medical products with foreign components. Dr. von Eschenbach's testimony included a review of the Beyond our Borders initiative and the importance of an FDA presence in China. The Commissioner stated that "limited engagement" with India's agency counterparts was planned for the near future.

More information may be found on the FDA's website:
http://www.fda.gov/ola/2008/foreigninspection042208.html

Back to HCB News

More Industry Headlines