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Current Location：News Center >>Chinese traditional medicine information
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Seven channels to the American market
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If Chinese medicine want to enter into the United States market,it should go through the FDA (Food and Drug Administration) certification.
Chinese medicine can be (1) Food, (2) health food, (3 Dictory Supplement); (4) cosmetics (5) Topical drug herbs (6) National Drug certification; (7) the form of new drugs and so on ,which can apply for FDA certification procedures.
1. Food : It refers to the ordinary food. FDA will analy companent of import products,monitor pesticide residues, micro-organisms and toxins, have strict requirements on the text and packaging. There are special requirements and needs for canned food, drinks and others,such as they should go though FCE (factory registration), SID (product registration). China's health care products oral liquid, tea and other health food can be submitted for approval by FDA.
2. Health Food: also known as the effective food. In addition to the general requirements of FDA food import standards, it has also stressed the improvement of human health food functions, the effectiveness of disease prevention. At the same time the outpacking and programmes should meet the FDA's regulations, such as China's honey categories, pollen and ginseng fine food, which price are higher than ordinary food .
3. Dictory Supplement: This is the laws and regulation passed in May 1995. It is nearly medicine, including amino acids, trace elements, vitamins, minerals and herbs, and other types of products. Product brochures can be referred to preventation of disease and improve the function of the human body and stressed the mechanism, rather than effectiveness. Such products can be bought in different forms in the health goods. It is more easier for Chinese medicine products to submit to FDA approval, but also relatively easy to embody the actual functions and values of the Chinese herbal medicine treatment. This is the main breakthrough for traditional Chinese medicine to enter the international market.
4. COSMETIC:It refers to the clean, inverted, spraying, spraying, or other ways into the human body and used for any part to achieve cleaner, health care, landscaping, treatment, or change the appearance of the items.
5. Herbs topical drugs: made from pure natural extracts of plants or composition,with formulations such as patches, lotion, suppository and other form outside on the body, which plays a role in the treatment of health care products.
6. The NDC: it is a national pharmacopoeia of drugs, without need to apply for access to new drugs, but more strict,it should meet the United States FDA regulations. Chinese medicine products with standard numbers is possible to declare the NDC of the United States.
7. The NDA: The new drug need to implement a series of application procedures in the United States. the drug's pharmacology, toxicology and safety should do a strictly technical testing, including 23 tests, about 1,000 cases for about 8 years, the cost is above billion dollars and it is the most complex programs ,the longest time, the highest cost, a maximum profits of five forms. |
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Published：2008-04-18
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