SFDA crackdown to get house in order

By Nick Taylor

- Last updated on GMT

Related tags: New drug applications, Pharmacology

The Chinese State Food and Drug Administration (SFDA) has revealed
plans to tighten the drug registration review process as it
attempts to improve standards in the nation.

At the regulatory body's monthly press conference a SFDA spokesman spelt out the policy which will only allow drug companies one opportunity to file their application documents. By adopting a hard line stance the SFDA is sending out a strong message to its critics both at home and abroad who have cast aspersions on the integrity of the registration process. SFDA spokesperson Yan Jiangying said: "In cases where a company's application does not satisfactorily prove the safety and efficacy of its product, the SFDA will no longer ask for further information, unlike in the past, but will simply reject the application outright​." This shift in policy is the result of an in-depth review of documents submitted to the SFDA between January and April this year to verify all information in the applications through pharmacological, toxicological and clinical trial analysis. From this the SFDA discovered that some of the drug application documents were quite similar, which it believes is likely to signify that the company has fabricated the data. The SFDA is also conducting a "concentrated​" review of applications submitted prior to October 1 2007. This entails pharmaceutical and medical experts looking over the applications, the majority of which are for existing drugs in new specifications or dosage forms. Both these schemes are following on from a broader rectification campaign which ran between July 2006 and December 2007 and attempted to overhaul the drug registration process in China. Since the SFDA began the campaign in July 2006 it claims to have rejected 7,999 new drug applications and recalled 1,604 drugs or medical devices that had previously been approved. The number of rejections is indicative of both the new found vigilance of the SFDA and the laxness and corruption that existed in the past. Many of the new drug applications that were approved in the past were simply existing drugs in different dosage forms or with new branding. This enabled pharmaceutical companies to sell their "new" products at inflated prices. The SFDA's reputation was severely tarnished by such practices and the corruption charges brought against its former chief Zheng Xiaoyu, for which he was executed in July last year. The regulatory body appears to be taking some of the necessary steps to rectify the situation but it is clear it has a long way to go before it becomes respected at home and abroad.

Related topics: Contract Manufacturing & Logistics, QA/QC

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