"China, Here We Come," Says FDA

March 20, 2008
Angie Drakulich
ePT--the Electronic Newsletter of Pharmaceutical Technology

As part of ongoing efforts to improve the quality of imported drug products, the US Food and Drug Administration is setting up shop in China.

Rockville, MD (Mar. 14)-As part of ongoing efforts to improve the quality of imported drug products, the US Food and Drug Administration is setting up shop in China. After finally receiving approval from the US State Department, FDA is making plans to establish eight full-time permanent positions at US diplomatic posts in China. The only potential hold-up is getting permission from the Chinese government.

If all goes well, FDA plans to fill the eight posts within the next 18 months. An additional five staff-all to be local Chinese nationals-will be hired to work with the new FDA staff at the US Embassy in Beijing and the US Consulates General in Shanghai and Guangzhou.

“In an age when a border is not a barrier, the globalized economy demands nothing less than heightened regulatory interoperability, information exchange, and cooperation, especially on product quality and enforcement matters,” said FDA’s Murray M. Lumpkin, MD, deputy commissioner for International and Special Programs, in an agency release. “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.”

The China-based offices are only the beginning of FDA’s new “Beyond our Borders” initiative, which was announced in late February. The program is meant to give the agency a greater presence and capacity abroad, starting with China. Four other regions will be targeted as well: India, the Middle East, Central America, and South America.

According to the agency news release, the China-based offices will also allow greater access for inspections and greater interactions with manufacturers to help assure that products imported into the US meet FDA standards.

Senator Chuck Grassley (R-IA) supports FDA’s expansion of overseas efforts. On Mar. 11, he proposed the use of registration fees as a way to help pay for more inspections of pharmaceutical drug manufacturers abroad and to limit the number of facilities that may register with the FDA without any intention of shipping products to the US. According to a letter he wrote to the agency’s commissioner and the US Secretary of Health and Human Services, medical device makers located outside the US are required to pay registration fees to FDA, under the Medical Device User Fee and Modernization Act (MDUFMA), and in accordance with a congressionally established schedule of registration fees. For FY 2008, MDUFMA registration fees are $1,706 and set to increase to $2,364 in FY 2012.

“There is currently no corresponding requirement that establishments involved in the production of drugs or active pharmaceutical ingredients pay registration fees,” wrote Grassley. “Though only a beginning, requiring registration fees for these establishments may help bolster the FDA’s inspection capacity while also reducing the number of establishments that register without shipping products to the United States.” Such fees could have a potentially huge impact given than there may be as many as 6800 foreign pharmaceutical manufacturing facilities importing products into today’s US market.