FDA Bid Forms
1,A food category (FOOD) : refers to the ordinary foodstuffs, with the exception of health examination also need to produce nutrition labeling.Beverages and canned food needed for FCE (Factories registered), SID (Registration).
2, health foods (HEALTH FOOD) : also known as functional foods, In addition to general food import standards, the need to improve the effectiveness of the function of the human body, but needs to be done nutrition labeling.
3, nutritional supplements (DIETARY SUPPLEMENT) : including amino acids, trace elements, vitamins, minerals and herbs category, according to FDA regulations produced, it can in drug brochures, packaging, reflected on the label of Chinese medicine, health care products to improve human functioning, the role of disease prevention.FDA for the composition of the overpack and labeling and strict requirements.
4, non-prescription medication (OTC) : argumentation do not need new drugs, but the need to provide adequate materials, determined in accordance with regulations effective components.FDA reached in a number of non-prescription medication requirements, American medicine and mouth Registration (NDC) in the United States market for pharmaceutical sales position.
5, cosmetics (COSMETIC) : refers to the rub, reversing spilled, sprayed, imported or otherwise used for any human body and its parts, so as to achieve cleaner, health care, landscaping, treatment or change of appearance items.
6, topical herbal drugs : from pure natural plant extracts or composition, dosage forms such as the use of outside patches, lotion, suppository form role in the human body and played the role of health treatment products.
7, GMP certification : domestic Xilueyuanliaolue wants legitimate access to the United States market to the United States must apply for FDA GMP authentication. The United States is also the GMP authentication products to the international market permits. Takes two stages :
(1)Preparation of DMF (DRUG MASTER FILE) reported to the FDA. DMF made the registration number.
(2) FDA officials to conduct on-site inspections and certification.
(2) FDA officials to conduct on-site inspections and certification.
Source:
http://www.estcl.org/category_Americasview_m_399.html
