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China's pharmarceutical watchdog vows to tighten approval procedures (2)
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21:23, July 11, 2007

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"In the past, the functions of some approved drugs were found to vary from the original applications, which endangered public health," Wu said.

Research institutes, manufacturers and individuals who apply for registration of new drugs should provide comprehensive, reliable research documents to prove the safety, effectiveness and quality of the drug, and pledge the truth and accuracy of all information in the application materials.

Under the revised regulation, those who use false application documents will be fined or deprived of the right to file applications, and the government will blacklist those who break the rules.

"Once a medicine manufacturer enters the blacklist, its products will also be listed," he added.

"This way, medicine approval will be placed under public supervision and avoid misuse of power," Wu said.

Source: Xinhua
[1] [2]




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