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 the penalties for producing counterfeit drugs.
Speaking at the agency’s first regular press conference, Wu Zhen, deputy-director of the SFDA said that starting October 1, it would introduce stricter measures to check drugs under approval, including intensifying examinations of production, spot testing samples and re-examining treatments already on market.
The current regulation on drug registration came into effect on May 1, 2005 and Wu stated that it was characterised by “lax monitoring and examination of production." He added that “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 regulation, those who use false application documents will be fined up to 30,000 yuan (nearly $4,000) and receive a three-year ban on testing drugs. "Once a medicine manufacturer enters the blacklist, its products will also be listed," or deprived of the right to file applications, and the government will blacklist those who break the rules. This way, medicine approval will be placed under public supervision and avoid misuse of power," Wu said.
The new rules will also establish a ‘fast-track’ process for the approval of innovative drugs, as well as 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 help that process is considerable. The announcement of tighter rules follows the execution of Zheng Xiaoyu, ex-head of the SFDA from 1998 to 2005, who had been sentenced to death for taking bribes to approve drugs.