Registration Permit is Required for 28 Pharmaceutical Excipients

The Regulation on Strengthening Supervison over Pharmaceutical Excipients has been effective since 1 Feb 2013. Since then, China starts to implement the management on pharmaceutical excipients based on their classification. For the new excipients and the excipients with high safety risk, the registration permit is required and excipient manufacturers need to get the Drug Manufacturing License. The other excipients are under control via the record-keeping approach.

Feb. 16th, 2013