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Published on 13 July 2007

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China to tighten drug regulation

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A day after the execution of its former chief for corruption, China’s State Food and Drug Administration has announced plans to tighten approval regulations and strengthen penalties for producing counterfeit drugs.

Speaking at the agency’s first regular press conference, SFDA deputy director Wu Zhen said that from 1 October his organisation would introduce stricter measures to check drugs under approval, including more intense scrutiny of production, spot-testing of samples and re-examination of treatments already on the market.

Mr Wu said current regulations on drug registration which came into effect on 1 May 2005 were characterised by lax monitoring of production. “Application documents have been inadequate and there have even been serious forgery problems, so it’s pretty hard to ensure the safety of drugs.”

Under the revised regulations, those using false application documents will be fined $4,000 and banned from testing drugs for three years. He said once a manufacturer is blacklisted its products will also be blacklisted (the firm will be deprived of the right to file applications). “This way, medicines approval will be placed under public supervision and avoid misuse of power,” Mr Wu said.

The new rules will also set up a “fast-track” process for approval of innovative drugs, plus stricter reviews of generic drugs to ensure they have the same effectiveness and safety profile as branded versions.

The move is the latest example of China looking to clean up its healthcare system and the pressure on officials to further that process is considerable. The announcement of tighter rules follows the execution of Zheng Xiaoyu, SFDA head from 1998 to 2005, who had been found guilty of taking bribes to approve drugs.

PharmaTimes 12/7/2007

 



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