China SAWS released on 25 Feb the updated Catalogue of industries applicable for Hazardous Chemicals Safe Use Permit 2013 (hereinafter as “Catalogue”) to replace its previous version issued in 2011. Companies that are included in the Catalogue and use HCs (for production purpose) with use quantities reaching the threshold annual tonnage specified in the “Use quantities standard for hazardous chemicals” are required to obtain the HCs Safety Use Permit, according to the SAWS Order 57 (Chemlinked news on 29 Nov 2012). The Catalogue 2011 contains 3 main industries, which are divided into 12 sub-categories with 38 types of products. Compared with it, the newly-updated version has cut two sub-categories and 13 specific products shown below:
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.