Regulatory Focus™ > News Articles > China: SFDA Issues New Draft Excipient Rules

China: SFDA Issues New Draft Excipient Rules

Posted 11 June 2012 | By Ansis Helmanis 

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

Under the draft guidelines, drug manufacturers will explicitly have the primary responsibility to assure the quality of the excipients that they obtain from their excipient suppliers. The goal of the draft rules is to "realize the full supervision of the pharmaceutical production and supply chain."


Read more:

SFDA - State Food and Drug Administration for public comment on the relevant provisions to strengthen the supervision and management of pharmaceutical excipients

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