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    New body to regulate drug approval will make little difference - public policy scholar 4/9/2006
    Shanghai. April 6. INTERFAX-CHINA - A major re-vamp of China's drug approval system, aimed at reducing corruption, will achieve little, says a public policy scholar.


    The State Food and Drug Administration (SFDA), which mainly deals with the approval of drugs, medical devices and health care products, launched a new administrative service centre on April 3.


    Zhang Jixiang, spokesman with the SFDA said, the new centre was part of the reform of the drug approval and registration system, and would reduce the amount of red tape companies had to negotiate before they could have their drugs approved.


    In the past, the application office, technical approval office, administrative approval office as well as the certificate-issuing office was located in different places, making things somewhat inconvenient.


    Previously, applicants were given scant information on the approval procedure, and would not be informed at what stage their application failed, if it was not successful.


    However, the new center separates the technical and administrative approval offices, and responsibility for each department is clarified. The center will have to process all applications within a certain time limit, and give clear reasons for any delay.


    Ma Huaide, director of the law college in the China University of Political Science said the new centre would be an effective tool in the fight against corruption. He said, "The division of the application, assessment and approval procedures at the center will solve some problems in the old system, and the public will also have a chance to inspect their work."


    He said the center would curb dubious goings-on and other "abnormal phenomenons" in the drug approval system.


    But Gu Xin, professor of the institute of social development and public policy of Beijing Normal University, told Interfax, he thought that the center would do little to prevent corruption.


    "There is a little progress towards improving the drug approval service, in terms of more transparency and efficiency," Gu said, "but, we should only say, the launch of the center represents a very small step for the government, and can't solve the problem of corruption fundamentally."


    He added, "Actually, in China, the approval procedure remains unclear not only to the pharmaceutical enterprises, but also to the public.


    "As a scholar, I am questioned how the government controls drug approval, and assesses applications," Gu Xin said. But he pointed out that a lack of transparent policies and regulations and an unbalanced information flow between the government and the public were major obstacles in improving the drug approval system.


    Corruption in the drug approval system reflected the pharmaceutical industry as a whole he said, including the high expense of medical treatment and business bribery throughout China's health care system.


    "To adopt all Chinese people in the health care insurance system will solve the corruption problem fundamentally, and at the same time, help solve the current problems in China's health care system generally," Gu said.


    Gu said that if this happened, the administrations of healthcare insurance would have more purchasing power, and more rights in selecting medical service providers, bringing down the cost of the medical services naturally.


    He admitted this was still an idealistic concept at the moment, not only for China, but also for many developed countries who would find it a challenge to adopt all people into a government-funded health care insurance system.


    "I believe the suggestion will be adopted one day, but it's just a matter of time," Gu said.

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