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China orders more rigor in approving new drugs
2007-07-12 02:56:34 Shanghai Daily

SHANGHAI, July 12 -- CHINA has strengthened its drug regulations and will carry out an extensive series of new measures to ensure the safety of its medical products, a top official said yesterday.

The announcement came one day after the state's former top drug regulator, Zheng Xiaoyu, was executed for taking bribes and dereliction of duty in allowing substandard medicines onto the market.

The new drug registration regulation takes effect on October 1, Wu Zhen, deputy director of the State Food and Drug Administration, told a news conference in Beijing.

"Before its revision, the regulation allowed lax monitoring and examination of production," Wu said.

"Application documents have been inadequate, and there have even been serious forgery problems, so it's pretty hard to ensure the safety of drugs.

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

Research institutes, manufacturers and individuals who apply for registration of new drugs must 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, the new rules state.

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

Wu said a group evaluation system will be established and the members of the group publicly identified.

He said all approval and inspection procedures will also be made transparent.

The State Food and Drug Administration said in March it would revise the current registration process for new medicines and released a draft version seeking opinions from the public.

Wu clarified that some previously reported information was taken out of context. Reports that the watchdog approved more than 10,000 kinds of new drugs every year were "not correct," he said.

Wu explained that of the 11,086 medicines approved in 2005, only 1,113 were new drugs. The others were either generic drugs or medicines that were already on the market but were slightly altered.

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