FDA (FDA) under the United States Department of Health Education and Welfare, is responsible for the drugs, food, biological products, cosmetics, veterinary drugs, medical devices and diagnostic supplies management. FDA under Drugs Agency, the Food Bureau, the Bureau of veterinary drugs, radiotherapy Health Bureau, the Bureau of Biological Products, medical equipment and diagnostic supplies and the National Toxicology Study Center, the regional administration, that is, six Bureau, a center and a regional management organizations.
FDA said in the country had 40 laboratories, 2,100 scientists working here. including 900 chemists and 300 microbiologists.
Drugs Board (also known as the drug evaluation and research center) is responsible for approving medicines for human use, with eight and the number of sections. Drugs Management Department.Drugs under the information, information systems design, administration and budget, Medical Library four sections. Drugs Oversight Office.Drugs available under the Quality Evaluation, drug labeling supervision, production and the quality of products, research investigation, and legal sections 7.Drug Standards Department. Evaluation with medicines, pharmaceutical listing and advertising two branches. Drugs a review. Cardiovascular under -- the kidney drugs, antineoplastic agents, nutritional medicine, medical surgical and dental imaging products Gastrointestinal and Coagulation Drug drug five sections. Review two drugs.Under anti-infective, metabolic and endocrine drugs, antivirals three sections. Epidemics and biological Census and Statistics Department. And the epidemic under investigation, biological statistics two sections. Research Branch. Department of imitation drugs. Under imitation drugs, bioequivalence two sections.
The United States Food and Drug Administration in Washington, DC and Maryland state Luokeweier City, the huge body, branches across the country. To enhance the quality of medicines management, FDA division of the country into six regions, namely the Pacific (San Francisco, Seattle, Los muscle), the Southwest (Dallas, Denver, Kansas), the Western (Chicago, Minneapolis, Detroit), Northeast (Boston, New York, Buffalo), the Atlantic Region (Philadelphia, Cincinnati, Newark, Baltimore) Southeast (Atlanta, Nashville, New Orleans, Orlando, the wave of Victoria St. Ji'an). Every district for a large district, the district where they erected a number of areas.Pacific Rim region as the location for San Francisco, the southwest region as the location for the Dallas, Central and Western regions by the location of Chicago, the Northeast region as the location for Boston, the mid-Atlantic region as the location for Philadelphia, the Southeast zone of the Atlanta location.
Areas are responsible for the region's food, pharmaceuticals, cosmetics, machinery, such as blood banks for supervision and inspection work. The region also need to work on the establishment of a number of workstations, to guarantee can cover the face area. There were currently 143 workstations. Large areas, regional recall workstations are directly under the FDA's institutions at all levels. District scale depending on the workload and set America, the drug over 65% in the mid-Atlantic production, Therefore, the strength of a strong area, a total of 525 workers, which monitors 250, FDA headquarters supervisors about the 1 / 4, analysis examiner 150.
State management of the medicines by local drug administration regulations, the main task is to : Pharmacists and registered for the examination, right medicine and pharmacy departments to conduct supervision and inspection, issuance or renewal of the permit, a suspension of the illegal operators permit on the location of the pharmacy institutions to conduct evaluations, reviews, etc. probationary pharmacies
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.
medical equipment products
radiation electronic products
nutrition and health products
Chinese herbal medicines and health care