In the past，registration and approval system was applied in APIs，pharmaceutical excipients and pharmaceutical packaging materials. On August 18，2015，the State Council issued the “Opinions of the State Council on Reforming the Review and Approval System for Drugs and Medical Devices” （No.44，2015），clarifying that “to implement the relevant review and approval of drugs and pharmaceutical packaging materials and pharmaceutical excipients. The separate review of pharmaceutical packaging materials and pharmaceutical excipients was changed to joint review and approval at the time of application for approval of drug registration”. On August 10，2016，the former State Food and Drug Administration （CFDA） issued the “Announcement on Matters Related with the Relevant Review and Approval of Pharmaceutical Packaging Materials，Pharmaceutical Excipients and Drugs by the Administration”，deciding to change the registration and approval system of pharmaceutical packaging materials and pharmaceutical excipients in the past to the joint review and approval at the drug registration application，and to stop issuing the relevant registration and approval documents separately. Since then，the era of drug review and approval reform with Chinese characteristics began. The relevant management system for the relevant review and approval of the APIs，pharmaceutical excipients and pharmaceutical packaging materials became more and more clear and standardized，which was conducive to the production cooperation of the manufacturing enterprises of preparations，APIs，pharmaceutical excipients and pharmaceutical packaging materials，and was beneficial to the development of China’s pharmaceutical industry and its integration with the international regulatory system.