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| Shakeup for Drug Licensing |
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China launched a national center yesterday to handle license applications for new drugs and medical devices as part of a campaign to fight corruption and increase efficiency. Prior to embarking on projects all drug makers must first submit application documents to the center, which comes under the State Food and Drug Administration (SFDA). The center, after ensuring the enterprises are legitimate and their products authentic, will then transfer the documents to a team of experts for close examination. Based on this the SFDA will give final approval for the drugs or medical devices, and licenses would be issued by the center. The center is also authorized to ask the experts and relevant SFDA departments to complete their work to a schedule, said Zhu Guofu, director of the center. Before the establishment of the facility it was the responsibility of the SFDA departments to accept, examine and approve license-related documents. However, those departments with approving authority had unsupervised power. This situation led to corruption. In early January, Cao Wenzhuang, 44, director of SFDA's Drug Registration Department, and five other officials were arrested and charged with taking bribes. Before Cao, Hao Heping, another SFDA official, former director of the Department of Medical Devices, was detained last June and accused of accepting bribes. The two cases are still under investigation and the amount of money involved is not known. Apart from setting up the center SFDA now also forbids drug makers from seeking different registered trade names for their products. The confusing registration process for new drugs and medical devices has been cited as a major cause for the rapid increase in the price of these goods in China. About 75 percent of Chinese people do not have medical insurance and many can do very little when they fall ill because of the hefty medical costs. One reason for the difficulties is that SFDA has approved a large number of so-called new medicines in recent years, said Wu Yongpei, director of the Pharmacy Regulation Department with the National Institute of Hospital Administration. SFDA approved around 10,000 new drugs in 2004 compared with just 148 in the US. With the new anti-graft measures in place it is estimated that China will now have less than 100 new drugs coming onto the market each year, SFDA said. In the past the National Development and Reform Commission reduced the prices of many medicines. However, because of the abuse of power by some SFDA officials pharmaceutical enterprises have simply changed the names of certain drugs. They then apply to SFDA for approval for the 'new' medicines and they're sold much higher prices. It seems that bribery permits these enterprises to get licenses to produce these drugs. One example is aspirin, an everyday pain-killer. It costs just 0.03 yuan (0.36 cents) to produce one tablet. But the product is difficult to find in China. Instead, other drugs with the same elements are sold at more than 0.63 yuan (7.7 cents) each. Therefore, it is common in China for one drug, such as penicillin, to have dozens of names and to be produced by many factories, Wu told China Daily. China has nearly 6,000 drug enterprises. (China Daily April 4, 2006)
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