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Regulatory Focus™ > News Articles > China: New Draft Rules On Excipients

China: New Draft Rules On Excipients

Posted 05 June 2012 | By Louise Zornoza

China's State Food and Drug Administration (SFDA) issued draft rules on 4 June that would require pharmaceutical manufacturers to establish a system of ensuring the quality of the excipients they use in their drug production. 

The draft establishes drug manufacturers as having the primary responsibility to assure the quality of excipients obtained from suppliers

The goal of the draft rules is to "realize the full supervision of the pharmaceutical production and supply chain," SFDA said in a statement.


Read more:

SFDA - Draft Rules on Excipients
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