Global demand for Traditional Chinese Medicine (TCM) continues to rise in recent years as its therapeutic value gains broader international acceptance. Customs authorities maintain quarantine and supervision for exports of plant and animal-derived medicinal materials. According to the Measures for the Supervision and Administration of Quarantine of Imported and Exported Traditional Chinese Medicine, TCM materials are defined as medicinal parts of plants or animals that undergo preliminary processing after harvesting. Typically, items declared for "medicinal use" and listed in the medicinal materials catalog of the Pharmacopoeia of the People's Republic of China qualify as TCM materials. Below are essential considerations for TCM materials exporters:
I. Requirements for Exporting TCM Materials
Exported TCM materials must comply with quarantine agreements, protocols, memoranda, or other binding arrangements established between the Chinese government and the importing country or region. Additionally, these shipments must satisfy all applicable standards or contractual requirements specified by the importing country or region.
II. Enterprise Qualification Requirements
(I) Manufacturers exporting TCM materials must comply with all applicable legal and regulatory standards of both the destination country or region and China.
(II) Manufacturers exporting TCM materials shall establish comprehensive epidemic control systems and product traceability mechanisms.
Specifically, such export manufacturers shall maintain complete documentation covering procurement and acceptance of raw and packaging materials, production and processing records, factory inspection reports, and inventory logs. These records shall detail all epidemic prevention measures including pest control and disinfection, applied throughout the production and processing procedure and enable full product traceability. All records must be accurate, retained for at least two years, and placed under clear management with designated personnel responsible for quarantine and epidemic control.
(III) Where the importing country or region mandates registration of TCM export manufacturers, Customs shall administer such registration. The registration remains valid for a period of four years.
(IV)Export manufacturers applying for registration shall submit such materials as the completed Application Form for Quarantine Registration of Outbound Chinese Herbal Medicine Production Enterprises, a layout plan of the production facility supported by photographs or video of key operational areas, documentation detailing product processing techniques, and other required supporting materials.
III. Standardized Export Declaration Requirements
Export consignors or their agents shall submit declarations for TCM materials via the China International Trade Single Window, with mandatory truthful declaration of the products' intended use. The following documents must be provided as required: commercial contract, invoice, and packing list; factory certificate of compliance issued by the manufacturing enterprise; written declaration confirming product compliance with the quarantine requirements of the importing country or region.
Declaration Guidelines: The General Administration of Customs implements a purpose-based declaration system for TCM material exports. When exporting TCM materials, enterprises must declare the intended purpose to the competent Customs authority as either "medicinal" or "edible." Materials declared as "medicinal" shall be items listed in the medicinal materials catalog of the Pharmacopoeia of the People's Republic of China, whereas those declared as "edible" shall be items permitted for food use under relevant national laws, administrative regulations, rules, or official documents, and shall undergo inspection and quarantine as food products.
IV. Conformity Assessment
Customs authorities conduct quarantine and supervision of exported TCM materials pursuant to relevant laws and regulations. Materials that pass quarantine inspection or qualify after phytosanitary treatment shall, upon application by the enterprise, be issued relevant quarantine certificates and granted export approval. Materials failing quarantine that cannot be effectively treated, disinfested, or reprocessed shall be deemed non-compliant and prohibited from export.
Export enterprises should thoroughly understand all applicable Customs clearance procedures and destination market access requirements beforehand, implement effective quality control measures for TCM materials, and cooperate with Customs authorities in daily supervision and on-site inspections.
Disclaimer：The above content is translated from Chinese version of China Inspection and Quarantine Times. The China Inspection and Quarantine Times version shall prevail.
