China Vows Tough Drug Enforcement, Or Else
Make a commentBy Ed Silverman // July 11th, 2007 // 9:45 am
Wishing to save his neck, Wu Zhen, deputy director of the State FDA, says the watchdog agency will tighten the approval procedures for new meds with a revised regulation on medicine registration taking effect on Oct. 1. He made the remarks today at the SFDA’s first regular press conference.
Mindful of what happened to the previous director - Zheng Xiaoyu was executed yesterday for corruption that allowed untested meds to reach consumers - Wu says the SFDA would take stricter measures to check drugs under approval. These would include intensifying examinations of production, spot testing samples, and re-examining drugs already on market. The current regulation on medicine registration came into effect on May 1, 2005.
“Before its revision, the regulation allowed for lax monitoring and examination of production,” Wu tells the Xinhua news agency, according to ChinaView.com. “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 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 adds. “This way, medicine approval will be placed under public supervision and avoid misuse of power.”