As recently reported by Bloomberg: China Drug Sales to the U.S. Grow Despite Safety Concerns at Home
Yet even as China’s drug industry has grown in global stature, so have questions about the safety of its products.
Consider: Last year, about 700 Chinese firms were told by regulators in China to review their pending applications to sell new drugs and voluntarily withdraw any that were false or incomplete. Within months, about 75 percent had been retracted by the manufacturers or rejected by Chinese officials.
Among those were some medicines that were separately approved for sale in the U.S. by the Food and Drug Administration. Some of the companies say their data in China were flawed because of faulty information by local research firms, and their applications for the U.S. usually include tests done by research firms in North America — indicating those drugs should be safe. Chinese pharma exports to the U.S. rose 4 percent last year.
The withdrawn applications in China show both the country’s progress and the scale of its task in cleaning up its sprawling pharmaceutical industry, which for years has been plagued by instances of substandard generics. At home, the government is seeking to elevate the standards of locally made medicines to curtail the use of expensive foreign-made drugs. At the same time, Chinese conglomerates with deep pockets are racing to ramp up quality to international levels to grab a bigger slice of the U.S. pharmaceutical market.
“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 the China Food and Drug Administration, said at a press conference last year, referring to locally made medicines sold in China. The China FDA didn’t respond to faxes seeking comment.
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