广州市易测检测技术服务有限公司
 
Seven Chinese way into the U.S. market
Release Date: [2017/3/30 15:34:25]    Total read [] Times

Traditional Chinese Medicine into the U.S. market need to FDA (U.S. Food and Drug Administration) found that Chinese medicine can (1) Food; (2) health food; (3) nutritional supplements; (4) Cosmetics; (5) Chinese herbal medicines for external use ; (6) National Drug verification number; (7) State the form of bid for five new drugs and other FDA certification procedures.

1, food (FOOD): means that the average food. FDA food import needs for the declared component analysis of pesticide residues, microorganisms and toxins, monitoring, and text printed on the packaging, there are strict requirements. Of canned food, drinks, phosphoric acid there are special requirements for handling FCE (factory up), SID (product registration) and so on. Oral health care products in China, health tea, and other food can also be submitted for approval by FDA.

2, Health Food (Health Food): also known as the effect of food. In addition to FDA food import standards required of the ordinary, but also stressed that healthy food can improve human body functions and prevent diseases. At the same time in terms of packaging and programs that meet the FDA regulations, China's honey category, such as pollen and ginseng green food are such fine, than ordinary food prices higher.

3, nutritional supplements (Dictory Supplement): This is the May 1995 implementation of the food products just laws. It is close to the drug class, including amino acids, trace elements, vitamins, minerals and herbs and other types of products may be mentioned in the product manual to prevent disease and improve human body's role, stressing mechanism, rather than effect. Such products can be in different forms to purchase goods in the health care products, medicine FDA approval of this product is easier, but also relatively easy to find this reflected the real herbal treatment capabilities and &#118alue. This is a traditional Chinese medicine to enter the international market, the main breakthrough.

4, cosmetics (COSMETIC): refers to the rub, pour, sprinkle, spray, import or otherwise used in any part of the body and to achieve clean, care, landscaping, the role of treatment or change the appearance of items.

5, herbal topical: the pure natural plant extracts or components, such as other formulations do not need patches, lotions, suppositories and other forms of the human body, play a role in health care treatment products.

6, National Drug Verification Number (NDC): is a national pharmacopoeia of existing drugs, new drugs do not need proof to enter the application, but requires more stringent, the need to meet U.S. FDA regulations. Number of Chinese products has medicine accurate declaration of the United States are possible NDC number.

7, the National Drug (NDA): the new drug in the United States, must perform a series of application procedures, the drug's pharmacology, toxicology and safety, and so do rigorous technical testing, including 23 trials, approximately 1,000 cases of about 8 years, cost more than five billion dollars in the form of procedure to apply the most complex and longest, most expensive, most profitable kind of

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