Traditional Chinese medicine is a treasure of ancient science in China and also the key to the treasury of Chinese civilization. Animal-derived TCM materials, represented by velvet antler, antlers and seahorses, have become unique medicinal resources in the TCM system due to their high content of active ingredients such as amino acids, lecithin and trace elements. The Guidelines will introduce the regulations on quarantine and supervision of imported animal-derived TCM materials.
I. Product Definition
According to the Measures for the Supervision and Administration of Quarantine of Imported and Exported Traditional Chinese Medicine, animal-derived TCM materials refer to the raw medicinal materials (such as earthworms, velvet antler, dried seahorse, etc.) formed by primary processing after harvesting from the medicinal parts of animals. TCM materials declared as "medicinal" shall be articles included in the medicine catalogue of the Pharmacopoeia of the People's Republic of China. TCM materials declared as "edible" shall be articles that can be used for food in accordance with national laws, administrative regulations, rules and documents.
II. Entry Quarantine and Supervision
To prevent the cross-border spread of animal diseases and ensure agricultural and forestry production, ecological safety and human health, the GACC implements full-chain supervision on imported animal-derived TCM materials.
(I) Access to countries or regions and their products
The GACC is responsible for formulating, adjusting and publishing the list of countries or regions allowed to import TCM materials and product types on the website of the GACC. The specific access list can be found in the "Catalogue of Quarantine-Approved Animal/Plant-derived Medicinal Materials and Exporting Countries/Regions" under the column of "Animal and Plant Quarantine Requirements and Warning Information" on the website of the Department of Animal and Plant Quarantine of GACC (http://dzs/customs.gov/cn/).
(II) Registration of overseas enterprises
Based on the results of risk analysis, the GACC determines the catalog of TCM materials that need to be registered with overseas production, processing and storage units, and implements dynamic adjustments, and implements the registration for overseas manufacturers of TCM materials included in the catalog. The registration validity period is 4 years. The specific access list can be found in the "Animal Products-Other Animal Products-List of Registered Production and Processing Enterprises of Overseas Animal-derived TCM Materials" under the column of "Enterprise Information" on the website of the Department of Animal and Plant Quarantine of GACC.
(III) Quarantine approval
The Entry Animal and Plant Quarantine Permit shall be Animal-derived obtained for TCM materials before import. The approval item shall be handled online. The applicant shall log in to the "Internet+Customs" for handling. The customs will conduct a comprehensive review according to legal conditions and procedures, with an approval time limit of 20 working days.
(IV) On-site quarantine
The customs conducts on-site quarantine of imported TCM materials according to the business system instructions, mainly including: checking the departure time and port, countries or regions passed through, loading list, etc.; whether the packaging is intact, whether it contains animal and plant packaging and bedding materials, and it complies with the provisions of the Packaging Quarantine Supervision and Management Measures; whether the TCM materials are corrupted and deteriorated, whether they carry harmful organisms, animal excrement or other animal tissues, etc., and whether they carry animal carcasses, soil and other prohibited items.
(V) Laboratory test
If symptoms of pests and diseases are found during on-site quarantine, or the laboratory test is required according to relevant work procedures, the customs will take samples of imported TCM materials and send them to the laboratory for testing.
(VI) Result evaluation and treatment
Imported TCM materials can only be sold, used or stored and processed in designated enterprises after they have passed quarantine and the customs has issued an entry goods inspection and quarantine certificate. If they fail to pass the quarantine and inspection, the customs shall issue a notice of quarantine treatment, and the owner or its agent shall carry out disinfection and disinfestation, return or destruction under the supervision of the customs. Those that have passed the disinfection and disinfestation treatment are allowed to enter China.
(VII) Quarantine treatment of means of transport
The means of transport and containers for the entry of TCM materials shall meet the safety and hygiene requirements. If epidemic prevention and disinfection treatment is required, it should be carried out under the supervision of the customs at the port of entry. Without the permission of the customs, imported TCM materials shall not be unloaded from transport vehicles and containers or delivered.
III. Suggestions for Import Enterprises
(I) Apply for quarantine approval in advance
According to Article 5 of the Measures for the Administration of Quarantine Examination and Approval of Entry Animals and Plants, the applicant shall apply to the approval agency and obtain the Entry Animal and Plant Quarantine Permit before signing a trade contract or agreement. It is recommended that import enterprises go through quarantine approval procedures in advance to avoid customs clearance delays caused by technical rectification and other reasons.
(II) Build a full-process compliance management system
The customs implements integrity management on the production and operation enterprises of imported and exported TCM materials. The domestic owners or their agents shall establish a traceability system for imported TCM materials, and keep records of the import, sales and processing of TCM materials for at least 2 years. Moreover, the TCM materials epidemic prevention and safety management personnel shall be provided to establish a TCM materials epidemic prevention management system.
(III) Other requirements
In addition to meeting the customs quarantine and supervision requirements, the imported animal-derived TCM materials shall also meet the relevant requirements of the State Food and Drug Administration. For details, please refer to the Administrative Measures for the Import of Drugs. (Author Affiliation: Huangpu Customs)
Disclaimer：The above content is translated from Chinese version of China Inspection and Quarantine Times. The China Inspection and Quarantine Times version shall prevail.