NMPA issued the Announcement on Enabling the Pharmaceutical Business Application System

2020-04-24 16:59:23 vcc 43

To implement the work requirements of the Executive Meeting of the State Council on online application and processing of import and export supervision documents, NMPA has integrated the development of a drug business application system to this end, covering the certificates for drug export sales, APIs exporting to EU drug substance, import and export of narcotic drugs and psychotropic substances, and the initial import of medicinal materials, etc. The system was launched on December 31, 2019, also with the functions of online application and processing of the R&D project approval of narcotic drugs and psychotropic drugs, and the record filing of TCM extracts. For detailed operating instructions, please see the attachment (Omitted). Where the drug export sales certificate and the certification documents for EU-bound export of APIs are filed in the self-built system of the provincial drug regulatory department in the locality, the self-built system may still apply.