Executive Briefings

500 Chinese Pharma Companies Registered in U.S., But Quality Continues to Be Stumbling Block

Chinese companies now account for more than 50 percent of the global active pharmaceutical ingredient (API) market. It has more than 500 companies registered to sell in the U.S. and 10 times that many serving its own market. But many of those continue to struggle to meet international standards.

As an example, Bloomberg says that last year Chinese authorities ordered about 700 Chinese firms to review pending drug applications and withdraw any that were false or incomplete in an effort to step up its drug quality oversight. About three-quarters of the applications were voluntarily withdrawn or rejected by China's regulators, even though some of the drugs also were approved for sale in the U.S.

Several of the company's explained the disparity by saying that their products sold in China were tested by Chinese labs that provided faulty information while those sold in the U.S. were certified by research firms in North American companies and, as a result, are safe. It was a sentiment that echoed China's regulators. 

"Drugs approved in the past are still being used, but there may not be accurate data to prove that their efficacy reached international levels," Wu Zhen, vice minister of China's FDA said.

Of course, the U.S. FDA is not relying on its Chinese counterparts to ensure drug safety. It has upped its own staff dedicated to plant inspections there and has recently posted a steady stream of warning letters issued to Chinese drugmakers.

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As an example, Bloomberg says that last year Chinese authorities ordered about 700 Chinese firms to review pending drug applications and withdraw any that were false or incomplete in an effort to step up its drug quality oversight. About three-quarters of the applications were voluntarily withdrawn or rejected by China's regulators, even though some of the drugs also were approved for sale in the U.S.

Several of the company's explained the disparity by saying that their products sold in China were tested by Chinese labs that provided faulty information while those sold in the U.S. were certified by research firms in North American companies and, as a result, are safe. It was a sentiment that echoed China's regulators. 

"Drugs approved in the past are still being used, but there may not be accurate data to prove that their efficacy reached international levels," Wu Zhen, vice minister of China's FDA said.

Of course, the U.S. FDA is not relying on its Chinese counterparts to ensure drug safety. It has upped its own staff dedicated to plant inspections there and has recently posted a steady stream of warning letters issued to Chinese drugmakers.

Read Full Article