On Wednesday, June 6, IPEC-Americas was notified that the Chinese Center for Drug Evaluation (CDE) had published the draft of the Chinese Excipient Dossier Requirements (“Requirement on the Registration Documentation for Pharmaceutical Excipients - Exposure Draft”). IPEC-Americas mobilized a team of excipient experts to review the dossier and they established the following recommendations: immediate changes with the expected detailed technical and/or processing requirements for suppliers and observing safety practices regarding toxicology studies. The IPEC-Americas team agreed with stated expectations for active pharmaceutical ingredients (APIs) and their manufacturers. Discussions will continue with both teams to assess dossier terminology such as ‘bridging justification’ to ensure all requirements are in line with current regulations regarding the CDER Pharm/Tox’s (ANDA) and (NDA).
You can access the translated version of the dossier here: http://www.cde.org.cn/news.do?method=viewInfoCommon&id=314504
You can access the IPEC-Americas team recommendations in the Document Depot: http://ipecamericas.org/