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Bloomberg: China Drug Sales to the U.S. Grow Despite Safety Concerns at Home
http://www.bloomberg.com/news/articles/2016-08-29/questions-linger-on-china-drug-safety-even-as-sales-rise-in-u-s
China Drug Sales to the U.S. Grow Despite Safety Concerns at Home
By Bloomberg News
August 29, 2016
Chinese drugs and pharmaceutical ingredients are found in medicine cabinets as far away as New York and Chicago, and the country's exports of pharmaceutical products and health supplements worldwide jumped 3 percent to $56 billion last year.
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 Within months, about 75 percent had been retracted by the manufacturers or rejected by Chinese officials.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.
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International Expansion
Another company, China Resources Saike Pharmaceutical Co., in December also pulled an application to sell an epilepsy medicine called levetiracetam in China, acknowledging that clinical trial data submitted with that application were flawed. Two weeks later, the same drug was approved for sale in the U.S.
Saike said the U.S. FDA waived a requirement to do human trials on the medicine and that other materials it submitted met the agency’s requirements for generic drug approvals. It didn’t respond to questions on where its tests were done.
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China Drug Sales to the U.S. Grow Despite Safety Concerns at Home
By Bloomberg News
August 29, 2016
Chinese drugs and pharmaceutical ingredients are found in medicine cabinets as far away as New York and Chicago, and the country's exports of pharmaceutical products and health supplements worldwide jumped 3 percent to $56 billion last year.
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.
<>
International Expansion
Another company, China Resources Saike Pharmaceutical Co., in December also pulled an application to sell an epilepsy medicine called levetiracetam in China, acknowledging that clinical trial data submitted with that application were flawed. Two weeks later, the same drug was approved for sale in the U.S.
Saike said the U.S. FDA waived a requirement to do human trials on the medicine and that other materials it submitted met the agency’s requirements for generic drug approvals. It didn’t respond to questions on where its tests were done.
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