FDA in China Increasing FDA Capacity in China

Editor: Anke Geipel-Kern

China moves this year even more into the focus of the FDA. The Authority will send more inspectors to China and train companies and government agencies intense.

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Ren De Quan, former Director CFDA speaking at Vogel Pharmaceutical Engineering International Forum 2013.
Ren De Quan, former Director CFDA speaking at Vogel Pharmaceutical Engineering International Forum 2013.
(Bild: PROCESS China)

This year FDA receives more money to carry out inspections in China. U.S. Food and Drug Administration maintains offices in Beijing, Guangzhou and Shanghai since 2009, which do not satify the inspectors expectations.

According to an FDA report, particularly Chinese API manufacturers do not work according to GMP and are considered as starting point of drug counterfeiting. This is particularly critical because now almost 80% of the APIS comming from China and India. Customers are primarily European and American pharmaceutical companies.

China, the problem now wants to tackle apparently stronger than before and has made an agreement with the U.S. government. As a result, the FDA should also train Chinese authorities in order to help them to better regulate pharmaceutical products which are exported to the United States.

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