Chinese FDA (CFDA) Order 134 "Matters Concerning Bundling Review and Approval of Pharmaceutical Packaging Materials, Pharmaceutical Excipients and Drugs" took effect on August 10, 2016. This order provides for the approval of pharmaceutical packaging materials and excipients in conjunction ("bundled") with drug product applications. Previously in China, packaging materials and excipients could be reviewed independently via the Import Drug License (IDL, Drug Licensing) process. READ MORE
CFDA Order 134 – Quite a Bundle for Excipient Makers Selling into China