IPEC e-newsletter - Excipients Insight December 2017 - 18-12-17


Inside this issue


China publishes new excipient regulation

There has been yet another development in the fast-changing Chinese regulatory environment for excipients, with a new regulation published towards the end of November.

The regulation (link to document in Chinese) introduces some fundamental changes to the way excipients are regulated in China. They will no longer be considered for approval separately but – along with active pharmaceutical ingredients and packaging materials – will now be regulated using a submission system akin to the Drug Master File (DMF) approach used in other regulatory jurisdictions.

Under the new system excipient companies can submit dossiers for excipients themselves, and after submission a registration number will be assigned, and these will be “reviewed and approved after the registration application of the connected drug product is proposed,” according to a translation of the regulation kindly provided by IPEC China.

IPEC China notes that according to the China Food and Drug Administration (CFDA) announcement, excipients used in imported finished drugs are also covered by the new regulation.

All excipients need to be registered if they are intended for use in a new drug application, except for those used in dedicated finished drugs. If used “by the drug product applicant only, or exclusively used by the particular marketing authorization holder”, a dossier needs to be included with the drug application.

CFDA is still working on the platform on dossier electronic submission. Before it is finished, registration applications to the Centre for Drug Evaluation (CDE) will have to be on CD-ROM. Other detailed requirements for bundling review and approval of the drug substances, excipients and drug packaging materials as well as drug products is also being developed by CFDA, and this should soon be published for comments, according to IPEC China.

An English translation of the new regulation is now available and can be requested from the IPEC Europe secretariat.




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