Healthy Skepticism Library item: 10860

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Publication type: news

China's pharmaceutical watchdog vows to tighten approval procedures
China View 2007 Jul 11
http://news.xinhuanet.com/english/2007-07/11/content_6361278.htm

Full text: BEIJING, July 11 (Xinhua) — China’s pharmaceutical watchdog will tighten the approval procedures for new medicines with the revised regulation on medicine registration taking effect on Oct. 1. Wu Zhen, deputy-director of the State Food and Drug Administration (SFDA), made the remarks on Wednesday at the SFDA’s first regular press conference. Wu said the SFDA would take stricter measures to check drugs under approval, including 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 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,” Wu said. “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.