An NSF International Company
Chinese Excipient Regulation
Friday the 10th August 2012
The Chinese SFDA has issued its final “Regulation of Strengthening Supervision on Pharmaceutical Excipients”.
IPEC China has kindly produced an English translation, which is attached. This new regulation is largely consistent with various IPEC Guidelines that have been developed over the last two decades. There are also several items which require additional clarification. Once that additional information is available it will be shared by IPEC. These requirements will be effective as of 01 February 2013.
