The State Drug Administration ("SDA") has recently issued the Announcement on Matters Concerning the Import Customs Clearance of Active Pharmaceutical Ingredients and Pharmaceutical Excipients (the "Announcement").
The Announcement stipulates that, for imported active pharmaceutical ingredients (APIs), and those pharmaceutical excipients listed in the appendix to the Announcement on Adjusting Names and Serial Numbers of Relevant Commodities in the Catalog of Imported Drugs, the importer may handle formalities with the port drug regulator to obtain the Customs Clearance Permit for Imported Drugs, by providing certain materials, such as approval documents of APIs / supporting documents for pharmaceutical excipients, certificate of origin, packing list, bill of lading, freight invoice and the delivery inspection report. In addition, the Announcement states that, for pharmaceutical excipients, port drug regulators shall clearly specify on the Customs Clearance Permit for Imported Products that "this product is a type of pharmaceutical excipients, rather than drugs, and port inspection is not required". According to the Announcement, any of five supporting documents, such as the "Registration Certificate for Imported Drugs for imported APIs" or the "Approval Document for Imported Drugs for APIs", may be used as a proof that the APIs have been approved.