China: New Draft Rules On Excipients
| Posted: 5 June 2012
By Louise Zornoza, RegLink
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.
SFDA - Draft Rules on Excipients
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