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US FDA chief going to China for drugs review

By PAUL WELITZKIN in New York (China Daily USA) Updated: 2014-11-17 10:26

The head of the US Food and Drug Administration (FDA) is going to China this week to complete agreements on inspection and regulatory reviews for drugs with seventh-largest provider of pharmaceuticals to the United States.

Dr Margaret Hamburg, who is scheduled to arrive in Beijing on Monday, will also attend the ninth International Summit of Heads of Medicines Regulatory Agencies meeting, which starts Wednesday. The three-day meeting is an important forum for the chief executives of major medicine regulatory agencies from around the world.

"I think we are in a productive place to share information and we have rapidly expanded our offices in China," she told China Daily in a preview of her trip to the mainland."We have also trained over 1,000 inspectors in China to ensure drugs and food coming from China meets the highest of standards."

China is also responsible for many of the active pharmaceutical ingredients (APIs) that make prescription and over-the-counter drugs work. It's an area that Hamburg believes will be ripe for targeted negotiations.

"CFDA (China Food and Drug Administration) has been working with us on API," she said."One of the issues that have come up is that API has been regulated as a chemical and not as a drug in China. There may be changes in that regulatory arrangement. We think that API is a critical component for which the CFDA should play a more active role."

Earlier this year, Christopher Hickey, director of the FDA's China office, told a Congressional hearing that improvements are needed in the production of drug ingredients in China to alleviate safety risks. The FDA China office was opened in 2008 after safety problems arose with Chinese products including a counterfeit active ingredient for the blood thinner heparin.

Hickey said there have been instances where inspectors were impeded."We now have the authority to put those firms on alert," he said.

Hamburg also believes that the Chinese now realize the importance of having a strong regulatory agency. In 2013 the CFDA was elevated back to a ministerial-level agency after a series of scandals.

"It takes time to build an agency with a knowledgeable staff. Remember the FDA here is over 100 years old," Hamburg said.

Earlier this month the FDA said it would increase the size of its office in China, adding more inspectors to check food exports to the US under an agreement reached last year between the agency and China. The expanded FDA office will total 26 US employees and seven Chinese staff members.

Hamburg said the FDA will add seven food and 10 drug inspectors to its China-based staff.

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