Forwarding the Announcement of the State Drug Administration on Matters concerning Import Customs Clearance of Pharmaceutical Raw and Auxiliary Materials (No. 8 of 2018)

According to the "Decision of the State Council on Canceling a Batch of Administrative Licensing Matters" (Guo Fa [2017] No. 46, hereinafter referred to as Document No. 46), and the former State Food and Drug Administration "Regarding the Adjustment of the Review and Approval of Raw Materials, Pharmaceutical Accessories and Pharmaceutical Package Materials Announcement (2017 No. 146, hereinafter referred to as Announcement No. 146), in order to regulate the import customs clearance of raw materials and pharmaceutical excipients, the relevant matters are hereby announced as follows:
1. For imported APIs, the importing unit may, with the API approval certificate, certificate of origin, packing list, bill of lading, freight invoice, factory inspection report and other information, to the port drug regulatory department for the "import drug customs clearance form".
2. API approval documents include one of the following:
Import Drug Registration Certificate for (I) imported API. For imported raw materials approved before the issuance of Announcement No. 146, the "Import Drug Registration Certificate" shall continue to be valid within the validity period. If the validity period expires, the "Import Drug Registration Certificate" shall be provided, which can continue to be used in the original drug or for research.
The (II) has obtained the registration number according to the requirements of Announcement No. 146 and has been identified as an API approved for use in marketed preparations. The search results of "API Registration Data" published on the portal website of the Drug Evaluation Center of the State Food and Drug Administration (hereinafter referred to as the Drug Examination Center) shall be provided for use by preparation companies using the API or for research.
If the (III) obtains the registration number according to the requirements of Announcement No. 146 and has not been identified as the bulk drug approved for use in the listed preparations, the search results of the "bulk drug registration data" publicized by the portal website of the Drug Examination Center shall be provided for research only.
"Import Drug Approval" for (IV) APIs: If the API to be used for research has not yet obtained a registration number, the "Import Drug Approval" shall be provided for research use only.
(V) other approval documents that permit the import of the API.
3., for the pharmaceutical excipients listed in the annex to the Announcement on Adjusting the Name and Number of Commodities in the Catalogue of Imported Drugs (No. 104 of 2011) jointly issued by the former State Food and Drug Administration and the General Administration of Customs, the importer may, on the basis of the certificate of pharmaceutical excipients, certificate of origin, packing list, bill of lading, freight invoice, ex-factory inspection report and other materials, go to the port drug regulatory department for the Customs clearance form. The port drug regulatory department shall indicate in the customs clearance form for imported drugs that "this product is a pharmaceutical excipient, not a drug, and does not need to be inspected at the port". Other pharmaceutical excipients not listed in the above-mentioned "Import Drug Catalog" do not need to apply for the "Import Drug Customs Clearance Form", and matters related to import customs clearance shall be implemented in accordance with the relevant regulations of the customs department.
4. supporting documents for pharmaceutical excipients include one of the following:
Registration Certificate of Imported Drugs (I) Pharmaceutical Excipients. For pharmaceutical excipients approved before the issuance of Document No. 46, the Import Drug Registration Certificate shall remain valid within the validity period. If the validity period expires, the Import Drug Registration Certificate shall be provided, and the imported pharmaceutical excipients may continue to be used in the original drug or for research.
The (II) shall obtain the registration number according to the requirements of Announcement No. 146 and have been identified as pharmaceutical excipients approved for use in listed preparations, and shall provide the search results of the "registration data of pharmaceutical excipients" publicized by the portal website of the Drug Examination Center for the preparation enterprises that use the pharmaceutical excipients or for research.
(III) the registration number is obtained according to the requirements of Announcement No. 146 and has not been identified as pharmaceutical excipients approved for use in listed preparations, the search results of "pharmaceutical excipients registration data" publicized by the portal website of the Drug Examination Center shall be provided for research only.
(IV) other approval documents that allow the import of pharmaceutical excipients.
It is hereby announced.

State Drug Administration

April 20, 2018