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Traditional Chinese medicine

Chinese medicinal materials refer to the medicinal parts of medicinal plants and animals, and the raw medicinal materials formed after primary processing after harvesting.

GACC registration conditions for overseas manufacturers of imported foods are as follows:

1. The food safety management system of the country/region where the manufacturer is located has passed GACC's equivalence assessment and/or review;

2. The manufacturer was established with approval by the competent authority of the country/region, and the manufacturer is under effective regulation by the competent authority;

3. The manufacturer has an established, effective food safety and sanitation management system and protection system, legally produces and exports food in the country/region, and ensures that foods exported to China comply with relevant Chinese laws, regulations, and national food safety standards;

4. Food exporting to China conforms with relevant inspection and quarantine requirements that have been agreed upon after discussion by the GACC and the competent authorities of the country/region.

Special reminders

The quarantine access of imported herbal medicines and the registration of overseas production enterprises have been adjusted to the new department and group of experts of the General Administration of Customs, and no longer refer to the "Catalogue of Food Products Imported to China from Countries or Regions Meeting the Requirements for Assessment and Review and Has Traditional Trade with China" The herbal medicine module of the catalog has recently been taken offline, and the new data must be referred to determine the quarantine access status, the enterprise registration conditions, procedures and required materials for specific herbal medicines. It should be emphasized that this is a brand new change and the fragmented information on the internet is almost all stuck in the old mode. It is recommended to communicate with us for confirmation before implementation to get straightforward and correct guidelines so as not to be misled by the complicated information.

Access steps for overseas Chinese herbal medicine manufacturers:

01
Overseas manufacturers should fully understand the requirements of the laws and regulations of the exporting country or region, the mandatory requirements of China's national technical specifications, and the inspection and quarantine requirements.
02
Submit an application to the local competent authority of the exporting country or region;
03
The relevant laws and regulations on animal and plant epidemics, veterinary health, public health, plant protection, enterprise registration management, etc. in the country or region where you are located, and the written information on the establishment and personnel of the competent authority in the country or region, and the implementation of laws and regulations, etc.
04
List of overseas production enterprises applying for registration;
05
The assessment conclusion conducted by the competent authority of the country or region where the companies are recommended of the actual situation of epidemic prevention and hygiene control;
06
A statement by the competent authority of the country or region where the overseas producers it recommends meets the requirements of Chinese laws and regulations;
07
Enterprise registration application, floor plan, process flow chart, animal or phytosanitary prevention and control system documents of plant, workshop and warehouse, photos of epidemic prevention and disinfection treatment facilities, photos of waste and packaging harmless treatment facilities, etc.
08
After the General Administration of Chinese Customs(GACC) has received the recommended materials and passed the written examination, after consultation with the competent authority of the exporting country or region, GACC may send personnel to the exporting country or region to evaluate its supervision system, and carry out the evaluation of the overseas production enterprises. After inspection, the applicant enterprises that meet the requirements shall be registered.
09
The General Administration of Chinese Customs(GACC) releases the list and updates the catalog at the same time.

Our assistance:

1. Assist in sorting out the requirements of the laws and regulations of the exporting country or region, the mandatory requirements of China's national technical specifications, and the inspection and quarantine requirements.

2. Assist the overseas enterprise to review the registration elements, complete the self-assessment, and provide continuous improvement plans according to the assessment results, so as to meet the registration conditions and the mandatory requirements of the Chinese technical specifications. Assist in sorting, screening, editing, and translating the required materials, so that the application materials meet the integrity, authenticity and validity requirements.

3. Assist in completing all application materials, fill in the application form and submit the application to the competent authority.

4. Follow up the application flow of competent authorities, embassies and GACC.
5. Materials correction, when the written materials do not meet the registration requirements, assist the enterprise to complete the interpretation, sorting, screening, editing, translation, calibration and other standards and laws and regulations of the required materials within the specified time.

6. Acceptance by Chinese Customs and follow-up and communication of technical review by expert group, preparation and coordination before on-site review or video review.
7. Assist in successful access and follow up on the use of registration data for customs clearance, and respond immediately if there are any problems.
8. Other enterprise access and follow-up related support.

The customs codes for imported Chinese medicinal materials are as follows:

GACC customs code for imported Chinese medicinal materials (Download)

According to the "Catalogue of Food Products Exported to China from Countries or Regions That Meet Evaluation and Review Requirements and Have Traditional Trade", if the country and access status are not listed, the General Administration of Chinese Customs(GACC) will conduct product risk analysis and supervision system evaluation on countries or regions that export Chinese medicinal materials to China for the first time. According to the risk analysis, assessment and review results, negotiate with the competent authorities of the exporting country or region to determine the quarantine requirements for exporting Chinese medicinal materials to China, negotiate and sign the relevant protocols, and determine the quarantine certificate.

The General Administration of Chinese Customs shall assess and review the equivalence risk of the supervision system of traditional Chinese medicinal materials in the country of origin (region):

01
Sort out the relevant laws and regulations on animal and plant epidemics, veterinary health, public health, plant protection, enterprise registration management, etc. in the country or region where you are located, as well as written documents on the establishment and personnel of the competent authorities in the country or region and the implementation of laws and regulations. material;
02
Make an application. The country (region) to be exported shall submit an application for export to China to the General Administration of Chinese Customs(GACC) in writing. The General Administration of Chinese Customs initiates the access procedure and provides the proposed exporting country with a risk assessment questionnaire;
03
Organizational evaluation. The intended exporting country will reply according to the questionnaire, provide relevant technical information, the General Administration of Chinese Customs(GACC) will conduct risk assessment, and send an expert group to conduct overseas field inspections as needed;
04
The General Administration of Chinese Customs (GACC) negotiates with the competent authorities of the exporting country or region to determine the quarantine requirements for exporting Chinese medicinal materials to China based on the risk analysis, assessment and review results, negotiate and sign the relevant protocols, and determine the quarantine certificate;
05
The overseas enterprise shall register with the General Administration of Chinese Customs (GACC) in accordance with the specific requirements of the protocol, and the General Administration of Customs (GACC) will issue a list of products exported to China from countries or regions that meet the assessment and review requirements;

Our assistance includes but is not limited to:

* Assist in the official arrangement, translation of laws and regulations and consultation

* Assist in providing the mandatory requirements of China's national technical specifications, and carry out translation publicity.

* Assist overseas competent authorities in filing applications and consultations with China

* Assisting with some embassy consultations or providing advisory support

* Assist the commercial counselor to communicate and consult with domestic and foreign competent authorities and enterprises

* Assist in consultation with the General Administration of Chinese Customs (GACC) on laws and regulations

* Assisting overseas producers to comply with protocol access requirements and providing advisory support

(Our assistance and consultation are unofficial acts, and only provide regulatory collection, translation, sorting, opinions or adjustment strategies, and do not represent official expressions.)

1. How to access botanical Chinese herbal medicines in the catalog?

Answer: If the access status of plant-derived Chinese medicinal materials is "normal", the overseas enterprises in the country do not need access application; those whose access status is "allowed to import from registered enterprises" need access registration (such as access in the past two years Greece and Afghanistan exported safflower to China). If the country and access status are not listed, the General Administration of Chinese Customs (GACC) will conduct product risk analysis and regulatory system assessment for the country or region that exports Chinese medicinal materials to China for the first time, whether the overseas manufacturers need to be registered is decided by the specific requirements of the protocol.

2. How to access Chinese herbal medicines of animal origin in the catalog?

For animal-originated Chinese herbal medicines, if the access status is "allowed to import, and registration is gradually completed", the overseas enterprises in the country do not need access application procedure; if the access status is "allowed to import from registered enterprises", access application is required. If the country is not listed, the General Administration of Chinese Customs (GACC) will conduct product risk analysis and assessment of the supervision system for the country or region that exports Chinese medicinal materials to China for the first time, whether the overseas manufacturers need to be registered is decided by the specific requirements of the protocol.

3. Does the domestic consignee of imported Chinese medicinal materials need to record?

Answer: yes, fill in the relevant information through the standard "Enterprise Qualification" subsystem of the "China International Trade Single Window" or the "Internet + Customs" and "Enterprise Management" subsystem of the General Administration of Chinese Customs, and submit paper application materials to the customs at the place where the industry and commerce are registered. .

4. Do all Chinese medicinal materials imported for "medicinal use" need to be approved for import of medicinal materials?

Answer: No, if the country of origin and product access conditions are met, if the Chinese medicinal material is listed in the "Catalogue of Non-First-Time Imported Medicinal Materials", it does not need to be processed.

5. What are the application channels and conditions for the approval of imported medicinal materials?

Answer: When importing medicinal materials for the first time, the applicant should fill in the application form for importing medicinal materials through the information system of the State Drug Administration, and submit the following materials to the local provincial drug administration:

(1) Application form for imported medicinal materials;

(2) A photocopy of the applicant's drug production license or drug business license. If the applicant is the holder of the marketing license for proprietary Chinese medicines, a photocopy of the relevant drug approval documents shall be provided;

(3) A copy of the main body registration certificate of the exporter;

(4) A copy of the purchase contract and its notarized documents;

(5) Information on the ecological environment, resource reserves, wild or planting and breeding conditions, harvesting and primary processing in the origin of medicinal materials;

(6) Standards and sources of medicinal materials;

(7) The original identification certificate of medicinal material origin issued by an institution with the qualification for identification of animal and plant origins in China, which contains the identification basis, identification conclusion, sample pictures, appraiser, identification agency and its official seal and other information.

6. What are the specific contents of the catalogue of non-first-time imported medicinal materials?

Number	Name	Origin base	Origin Place of production
1	catechu	Peeled branch, dried dry decoction of legume catechu Acacia catechu (L. f.) Willd.	Indonesia, Malaysia, Myanmar
2	American Ginseng	Dried roots of Panax quinquefolium L. of the Araliaceae plant	Canada, USA
3	Korean red ginseng	Steamed dry roots of the 6-year-old cultivar Panax ginseng C. A. Mey	South Korea
4	saffron	Dried stigma of Crocus sativus L., Iridaceae	Iran, Spain, Italy, Germany, France, Greece, India, Japan, Afghanistan
5	Sioux	The balsam resin exuded from the trunk of the witch hazel tree Liquidambar orientalis Mill. is processed and refined	UK, Turkey, Egypt, Indonesia
6	Frankincense	Resin exuded from the bark of Boswellia carterii Birdw. and Boswellia bhaw-dajiana Birdw. of the olive family Boswellia	Ethiopia, Kenya, Somalia, Sudan
7	myrrh	Dried resin of the olive plant Commiphora myrrha Engl. or Hadidin Commiphora molmol Engl.	Somalia, Kenya, Ethiopia
8	dried blood	Processed resin exuded from the fruit of the palm plant Daemonorops draco Bl.	Singapore, Indonesia, Malaysia
9	Agarwood	Rhizoma Aquilaria Aquilarla agallocha Roxb. Wood containing resin	Indonesia, Malaysia, Vietnam
10	sandalwood	Dried heartwood of the trunk of Santalum album L.	India, Indonesia, Timor-Leste, Australia
11	cloves	Dried flower buds of Eugenia caryophyllata Thunb.	Zanzibar, Sri Lanka, Indonesia, Madagascar, Brazil
12	cumin	Dried ripe fruit of the Umbelliferae plant Foeniculum vulgare Mill.	Indonesia, India, Iran, Turkey
13	longum	Dried near-ripe or ripe ear of Piper longum L.	Indonesia, Philippines, Vietnam
14	Cardamom	Dried ripe fruit of Amomum kravanh Pierre ex Gagnep. or Amomum compactum Soland ex Maton of Zingiberaceae	Indonesia, Thailand, Cambodia
15	Nutmeg	Dried kernels of Myristica fragrans Houtt. of Myristica fragrans Houtt.	Indonesia, Sri Lanka, Malaysia, India, Nepal
16	big belly	Dried peel of the palm plant Areca catechu L.	Indonesia, Myanmar, India, Malaysia, Vietnam, Pakistan, Thailand, Philippines, Cambodia
17	big wind	Dried ripe seeds of Hydnocarpus anthelmintica Pierre	Thailand, Vietnam, Malaysia
18	Western Green Fruit	Dried young fruit of the Clivia plant Terminalia chebula Retz.	India, Myanmar, Malaysia
19	myrobalan	The dried ripe fruit of Terminalia chebula Retz. or Terminalia chebula Retz. var. tomentella Kurt.	India, Indonesia, Myanmar, Sri Lanka, Nepal
20	fat sea	Dried ripe seeds of Sterculia lychnophora Hance	Thailand, Vietnam
21	aloe vera	Aloe barbadensis Miller of Liliaceae, Aloe ferox Miller of Cape of Good Hope, or the dried sap of leaves of other related plants in the same genus	Curacao, Aruba, Bonaire, Kenya
22	monkey jujube	From the abomasum (the fourth stomach of a ruminant) of the goat Capra hircus, formed after the goat has eaten acacia seeds, small pieces of wood, pebbles, or other foreign objects	India
23	Cinnamon	Dried bark of Lauraceae plant Cinnamomum loureiri Nees	Myanmar, Vietnam
24	Senna	Dried leaflets of the legume Cassia angustifolia Vahl or Cassia acutifolia Delile	India, Egypt, Myanmar
25	horse money	Dry ripe seeds of Strychnos nux-vomica L. of the Strychnaceae plant	India, Thailand, Myanmar
26	Tianzhu yellow	Dried lumps of exudates from the culms of Poaceae Bambusa textilis McClure or Schizostachyum chinese Rendle	Indonesia, Singapore, Thailand, Malaysia
27	hippocampus	Dried body of Hippocampus kelloggi Jordan et Snyder, Hippocampus histrix Kaup, Hippocampus kuda Bleeker, Hippocampus trimaculatus Leach or Hippocampus ja ponicus Kaup	Thailand, Malaysia, Philippines, Singapore, Indonesia
28	Gecko	Dried body of the gecko gecko Gekko gecko Linnaeus	Thailand, Indonesia, Cambodia
29	Korean Red Ginseng	Steamed dried roots of Panax ginseng C. A. Mey, a 6-year-old cultivar of Araliaceae	North Korea
30	Dendrobium	Fresh or dried stems of orchids Dendrobium nobile Lindl., Dendrobium chrysotoxum Lindl. or Dendrobium fimbriatum Hook	Thailand, Laos, Vietnam, Myanmar
31	Amomum	Dried ripe seeds and fruits of Amomum xanthioides Wall	Japan, Myanmar, Vietnam, Thailand, Indonesia
32	Tsaoko	Dried ripe fruit of Amomum tsao-ko Crevost et Lemaire	India
33	gallic	Dried galls on young branches of beech tree Quercus infectoria Oliv	Turkey, Iran, Greece, India
34	wooden butterfly	Dried mature seeds of Oroxylum indicum (L.) Vent.	Myanmar
35	Fang catecha	Rubiaceae Uncaria catechu Uncaria gambier (Hunter) Roxb. Dry decoction with leafy twigs	Malaysia, Indonesia, Myanmar
36	Antelope horn	Horns of the bovine saiga Saiga tatarica Linnaeus	Russia
37	Benzoin	Dried resin of Styrax tonkinensis (Pierre) Craib ex Hart.	Thailand, Vietnam, Laos
38	Garcinia Cambogia	Garcinia garcinia hanbyryi Hook f. resin oozing from the trunk	Thailand, India
39	female cloves	Dried near-ripe fruit of Eugenia caryophyllata Thunb. of the Myrtaceae plant	Zanzibar, Madagascar, Sri Lanka
40	Fairy Guangtian	Dried seeds of Hygrophila megalantha Merr.	Vietnam, Myanmar
41	betel nut	Dried ripe seeds of the palm plant Areca catechu L.	Indonesia, Myanmar, India, Malaysia, Vietnam, Pakistan, Thailand, Philippines, Cambodia
42	Hu Huanglian	Dried rhizome of Picrorhiza scrophulariiflora Pennell	India, Nepal
43	Tortoiseshell	Carapace (spine scales and rib scales) of the turtle Eretmochelys imbricata (Linnaeus)	Indonesia, Philippines
44	Cassia Shi	Shells of Haliotis diversicolor Reeve, Haliotis discus hannai Ino, Haliotis ovina Gmelin, Haliotis ruber (Leach), Haliotis asinina Linnaeus or Haliotis laevigata (Donovan)	Japan, Australia, New Zealand, Indonesia
45	seal kidney	Sea lion seals Callorhinus ursinus Linnaeus. dry male external genitalia (penis and testes)	America / Canada
46	sea dragon	Syngnathus Diaohailong Solenognathus hardwickii (Gray), multi-thorn Diaohailong Syngnathus guntheri Dunker's dry body	Thailand, Indonesia
47	Asafetida	Oleoresin collected from fresh rhizomes and roots of Ferula assafoetida L. and other plants of the same genus	Iran, Afghanistan, India
48	deer whip	Dried penis and testicles of cervus sika deer Cervus nippon Temminck or red deer Cervus elaphus Linnaeus	New Zealand, Australia
49	deer tail	Dried tail of red deer Cervus elaphus Linnaeus or sika deer Cervus nippon Temminck	New Zealand, Australia
50	Natural Borneol (D-borneol)	The fresh branches and leaves of Lauraceae Cinnamomum camphora (L.) Presl are extracted and processed	Indonesia
51	Sophora japonica	Dried flowers and buds of the legume Sophora japonica L.	Vietnam
52	Licorice	Dried roots and rhizomes of the legume Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L.	Pakistan, Afghanistan, Tajikistan, Uzbekistan, Kazakhstan, Azerbaijan, Kyrgyzstan, Turkmenistan
53	Ibemus	Dry bulb of Fritillaria walujewii Regel or Fritillaria pallidiflora Schrenk of Liliaceae	Kazakhstan, Kyrgyzstan
54	Pangosaurus	Dried rhizomes of Dioscorea nipponica Makino, Dioscorea nipponica	North Korea
55	Cistanche	Dried fleshy stems with scaly leaves of Cistanche deserticola Y.C.Ma or Cistanche tubulosa (Schenk) Wight	Turkmenistan, Kazakhstan
56	Guan Huangbai	Dried bark of Phellodendron amurense Rupr.	North Korea
57	Schisandra	Dried ripe fruit of the Magnoliaceae Schisandra chinensis (Turcz.) Baill.	North Korea
58	Asarum	Dried roots and rhizomes of Asarum heterotropoides Fr. Schmidt var. mandshuricum (Maxim.) Kitag., Asarum sieboldii Miq. var. seoulense Nakai or Asarum sieboldii Miq.	North Korea
59	Windproof	Dried root of Umbelliferae windbreak Sposhnikovia divaricata (Turcz.) Schischk.	Mongolia, Russia
60	Turmeric	Dried rhizomes of the ginger plant Curcuma longa L.	Indonesia, Myanmar, India
61	Cassia	Dried mature seeds of the legume Cassia obtusifolia L. or Cassia tora L.	India, Nepal
62	Mao myrobalan	The dried ripe fruit of the Gentianaceae plant Terminalia bellirica (Gaertn.) Roxb.	India, Nepal
63	Empress	Dried ripe fruit of Phyllanthus emblica L., Euphorbiaceae	India, Nepal
64	Jujube	Dried ripe fruit of the Anacardiaceae plant Choerospondias axillaris (Roxb.) Burtt et Hill	India, Nepal
65	Tibetan madder	Rubia family Rubia wallichiana Decne. and Tibetan Rubia R.tibetica Hook.f. and dried roots and rhizomes of several plants of the same genus	India, Nepal
66	Indian Sweater	Gentianaceae Swertia chirayita (Roxb. ex Flemi) Karsten dry whole herb	India, Nepal
67	Comfrey	The female body of Laccifer lacca Kerr., a lacquer, parasitizes the trunks of various plants, such as Dalbergia L. f. and Eriolaenea DC. thing	India, Nepal
68	Broad vine	Dried stems of Tinospora cordifolia (wulld) Miers or T. sinensis (Lour.) Merr.	India, Nepal
69	big stipule	Dried mature seeds of legume Caesalpinia crista L.	India, Nepal
70	white fresh skin	Dried root bark of Dictamnus dasycarpus Turcz.	North Korea, Russia
71	northern bean root	Dried rhizome of Menispermum dauricum DC.	North Korea
72	Psoralea	Dried ripe fruit of the legume Psoralea corylifolia L.	India, Myanmar
73	Poria	Dried sclerotia of Poria cocos (Schw.) Wolf	Madagascar
74	Drynariae	Dried rhizomes of Quercus Drynaria fortunei (Kunze) J. Sm.	Myanmar
75	black seed	Dried mature seeds of Ranunculaceae Nigella glandulifera Freyn et Sint.	Pakistan
76	Safflower	Dried flowers of safflower Carthamus tinctorius L.	Kazakhstan
77	Mistletoe	Dry leafy stem branch of Viscum coloratum (Komar.) Nakai	Ukraine
78	Polygonatum	Dried rhizomes of Liliaceae Polygonatum kingianum Coll.et Hemsl., Polygonatum sibiricum Red. or Polygonatum cyrtonema Hua	Nepal
79	Scutellaria	Dry root of Scutellaria baicalensis Georgi	Russia
80	Chickweed	Dried whole plant of the legume Abus cantoniensis Hance	Myanmar
81	mustard seeds	Dried mature seeds of the cruciferous plant Sinapis alba L. or Brassica juncea (L. ) Czern. et Coss.	Mongolia
82	Honeysuckle	Dried flower buds or with first blooms of the honeysuckle Lonicera japonica Thunb.	North Korea
83	Bitter almonds	Dry ripe seeds of Rosaceae Prunus armeniaca L. var. ansu Maxim., Siberian apricot Prunus sibirica L., Northeastern apricot Prunus mandshurica (Maxim.) Koehne or apricot Prunus armeniaca L.	North Korea
84	Lingzhi	Dried fruiting body of Polyporaceae fungus Ganoderma lucidum (Leyss. ex Fr. ) Karst. or Ganoderma sinense Zhao, Xu et Zhang	America
85	Vitex	Dried ripe fruit of the Verbena plant Vitex trifolia L. var. simplicifolia Cham. or Vitex trifolia L.	Myanmar
86	Equisetum	Dry aerial part of the Equisetum Equisetum hyemale L.	North Korea
87	Nansha ginseng	Dried root of Adenophora tetraphylla (Thunb. ) Fisch or Adenophora stricta Miq.	North Korea
88	Gentiana	Dry roots of Gentiana Gentiana macrophylla Pall., Gentiana straminea Maxim., Gentiana crassicaulis Duthie ex Burk. or Gentiana dahurica Fisch.	Russia
89	Cimicifuga	Dried rhizomes of Ranunculaceae Cimicifuga heracleifolia Kom., Cimicifuga dahurica (Turcz.) Maxim. or Cimicifuga foetida L.	North Korea
90	pine pollen	Dried pollen of Pinus massoniana Lamb., Pinus tabulieformis Carr. or several species of the same genus	North Korea
91	Wei Lingxian	Dried roots and rhizomes of Ranunculaceae Clematis chinensis Osbeck, Clematis hexapetala Pall. or Northeast Clematis manshurica Rupr.	North Korea
92	Curcuma	Dried rhizomes of Curculigo orchioides Gaertn.	Myanmar
93	Polygonatum	Dried rhizomes of Polygonatum ordoratum (Mill.) Druce of Liliaceae	North Korea