Don't believe everything you read. That's the message from Chinese drug regulators who say many domestic pharmaceutical companies claim their products are approved by the US Food and Drug Administration, but in fact no Chinese products have ever been approved as a drug by the FDA.
A few traditional Chinese medicines have, however, been approved by the US regulatory body as food, which is much easier to do than gaining approval as a drug.
"These ads are very misleading," Xu Zhou, a spokesman for the Shanghai Drug Administration told a three-day US-Sino Pharmaceutical Regulation Seminar which opened yesterday in Shanghai.
The seminar, sponsored by the State Drug Administration of China and the US Department of Commerce, was organized to help Chinese officials learn how the FDA works and how Chinese pharmaceutical regulations can be improved.
More than 100 pharmaceutical regulators from around the country will take part in seminars lead by five experts from the FDA.
Chongqing Taiji Group had to change its ads for a weight-loss product called Qumei because they claimed the drug was the first diet pill ever to receive FDA approval. Not true.
Qumei, which means beautiful curves, isn't for sale in the United States and has never been approved by the FDA, but the product uses the same main ingredient, Sibutramine, as an American diet pill called Reductil, which is FDA approved.
An official from Chongqing Taiji Group said yesterday that the company realized a few months ago that its ads were not properly phrased and altered the ads.
Officials at the meeting said ads for another Chinese product, called Compound Danshen Dropping Pill, are factually correct, but very misleading to consumers.
The traditional Chinese medicine, which is used to treat coronary heart disease, is advertised as a drug, but only approved by the FDA as a food.
"China should do more to build a sound drug registration and safety supervision system to keep up with developed countries," said Wang Longxin, director of the Shanghai Drug Administration.
The biggest barrier for Chinese drug manufacturers to receive FDA approval is the regulator's strict regulations, officials said.
Before the U.S. regulator will approve a new drug, the manufacturer must provide the FDA with substantial evidence of its safety and effectiveness based on well-controlled studies, said David A. Lepay, the FDA's senior adviser for clinical science.
"However, Chinese drug manufacturers engage in many irregular practices," said Du Wenmin, director of Shanghai Adverse Drug Reaction Supervision Center.
Because of this, studies performed at domestic research facilities aren't recognized internationally, so they can't be used to gain FDA recognition for a product, according to Du Wenmin.
(eastday.com June 7, 2002)
