China Rule Puts Primary Responsibility for Excipient Quality on Drug Manufacturers
| Posted: 3 August 2012
By Louise Zornoza, RegLink
Pharmaceutical manufacturers will bear primary responsibility for assuring the quality of the excipients used in their products according to a new regulation announced by China’s State Food and Drug Administration (SFDA) at a press conference 1 August 2012.
Under the regulation, manufacturers will be required to establish an excipient quality management system, enter into quality agreements with excipient suppliers and implement supplier audits. The regulation further addresses the need for provincial and municipal drug regulatory authorities to ensure that excipient manufacturers are licensed and that non-compliance with licensing requirements are “severely dealt with.”
SFDA and its branches will also raise standards for excipients when approving new medicines. Excipients that are new on the market or contain greater safety risks need to be registered and approved and their producers will have to obtain production licenses from authorities.
A National Excipient Monitoring Database
Other excipients and their producers will also be monitored. The SFDA will set up a national database to monitor the production and application of all pharmaceutical excipients, as well as a credit reporting system for producers, said Zhang Wei, head of the SFDA’s registration division. The regulation says pharmaceutical manufacturers should monitor the suppliers of the excipients they use and should be held responsible for quality control problems resulting from the use of illegal and substandard excipient products.
The tougher measure follows a scandal earlier this year in which several companies allegedly manufactured drug capsules with industrial gelatin, which contains excessive levels of chromium and is illegal to use for making drug capsules. The industrial gelatin was reported to have been made from leather scraps. Following a month-long inspection effort, the SFDA announced in May that 254 pharmaceutical enterprises, or 12.7 percent of all capsule makers in the country, were found to be producing unsafe drug capsules, with 5.8 percent of tested drugs determined to contain excessive levels of chromium.
SFDA - State Food and Drug Administration notice issued to strengthen the relevant provisions of the supervision and management of pharmaceutical excipients (Han Chinese)
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