CFDA Order 134 – Quite a Bundle for Excipient Makers Selling into China

Chinese FDA (CFDA) Order 134 “Matters Concerning Bundling Review and Approval of Pharmaceutical Packaging Materials, Pharmaceutical Excipients and Drugs”1 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. Although this new system of “bundling” of excipients and packaging materials with the drug product approval brings China into line with the US and Europe, both of which already review excipients only in conjunction with drug applications, there are still many differences in the drug approval processes between the three regions.

In this new approval process, the “Approval Number” (AN) issued by the CFDA for the entire application will act as the confirmation that the excipient is permitted for use. Figure 1 compares the previous process (Drug Licensing) with the new “Bundling” process2.