"FDA" is the U.S. Food and Drug Administration in abbreviation, the English called the food and drug administration. It is authorized by the U.S. Congress that the federal government, specializing in the Food and Drug Administration's top law enforcement agency. FDA is a doctor, a lawyer, microbiologists, pharmacologists, chemists and other professional personnel composed of statisticians dedicated to protect, promote and enhance the U.S. national health monitoring of government health regulatory agency. FDA must ensure that the U.S. market, all food, medicines, cosmetics and medical devices on the human body is a safe and effective. Outside the United States the production of food, health care products, additives market, without going through FDA approval, as long as the market before the FDA can be registered through customs inspection, generally a few weeks to several months, costs thousands to 3 million. But the FDA asked manufacturers to ensure food hygiene and safety standards, and conduct spot checks from time to time, such as non-compliant, you can eliminate from the market. The drug market, must be FDA approved new drug application approval process is extremely complicated and very strict.
FDA's bid form 1. Food (FOOD): refers to the ordinary food, in addition to health surveys, also need to make nutrition labeling. Beverages and canned food needed to apply for FCE (Factory Registration), SID (product registration). 2. Health Food (HEALTH FOOD): also known as functional foods, in addition to ordinary food import standards, the need to have a function to improve the effectiveness of the human body, but need to do nutrition labeling. 3. Nutritional supplements (DIETARY SUPPLEMENT): including amino acids, trace elements, vitamins, minerals and herbal categories, according to FDA regulations making, it can in the drug brochures, packaging, labeling on the expression of Chinese medicine, health care products to improve human function, The role of disease prevention. FDA for the composition of the description and packaging and labeling, there are strict requirements. 4. Non-prescription drugs (OTC): do not need proof to do drugs, but the need to provide sufficient material, the active ingredients found in accordance with laws and regulations. FDA in achieving the requirements of the non-prescription drugs, and drug exit goods received U.S. registration number (NDC) in the United States after the market on sales of drugs targeting. 5. Cosmetics (COSMETIC): refers to rub down, sprinkle, spray, import or otherwise used for the human body and any of its parts in order to achieve clean, health care, landscaping, treatment or effect of changing the appearance items. 6. Chinese herbal medicine for external use drugs: from pure natural plant extracts, or the composition of dosage forms such as the outside do not need to patch, lotion, suppositories and other forms of acting on the human body, play a role in health care treatment products. 7. GMP certification: domestic 西药原料药 order to legally enter the U.S. market, we must apply for GMP certification to the U.S. FDA. USA GMP certified products into the international market is also a "pass." Need to consist of two phases: (1) Preparation of DMF (DRUG MASTER FILE) reported to the U.S. FDA has made DMF registration number. (2) The United States FDA officials to conduct spot checks and certification.
