1. Market access system, which is the strength of the company's size of the investigation, in fact, it is very simple, even if there is now a requirement for this, there are still a lot of black hearted enterprises, not to mention that there is no requirement for what it is like.
2. Social responsibility, the bottom line to protect people's lives and health.
3. The necessary qualifications for medical enterprises.
The U.S. Food and Drug Administration (Food and Drug Administration) referred to as the FDA, FDA is the U.S. government in the Department of Health and Human Services (DHHS) and the Department of Public **** Health (PHS) in the establishment of one of the executive agencies. As a scientific regulatory agency, FDA is responsible for ensuring the safety of food, cosmetics, drugs, biologicals, medical devices, and radiological products manufactured in or imported into the United States. It was one of the first federal agencies whose primary function was to protect consumers.
The agency is relevant to the lives of every U.S. citizen. Internationally, the FDA is recognized as one of the largest food and drug regulatory agencies in the world. Many other countries seek and receive help from the FDA to promote and monitor the safety of their country's products.
The Food and Drug Administration (FDA) is responsible for the supervision and inspection of food, drugs (including veterinary drugs), medical devices, food additives, cosmetics, animal food and drugs, wine beverages with an alcohol content of less than 7%, and electronic products; it also includes cosmetics, products that emit radiation, and combination products, such as electronic products and medical products, that are related to personal health and safety. Products in the use or consumption process of ionic, non-ionic radiation affecting human health and safety project testing, inspection and certification. According to the regulations, the above products must be tested and certified as safe by the FDA before they can be sold in the market. the FDA has the right to inspect the manufacturers and the right to prosecute the violators. According to the supervision of different product range, can be divided into the following major regulatory agencies:
1, the Center for Food Safety and Practical Nutrition (CFSAN):
The center is the FDA's largest workload of the department. It is responsible for food safety throughout the United States, except for meat, poultry and eggs, which are under the jurisdiction of the U.S. Department of Agriculture. Although the United States has one of the safest food supplies in the world, approximately 76 million foodborne illnesses occur each year, 325,000 people require hospitalization for foodborne illnesses, and about 5,000 people die from foodborne illnesses. The Center for Food Safety and Nutrition works to reduce foodborne illness and promote food safety. It also promotes a variety of programs, such as the promotion of HACCP programs.
The functions of the Center include: ensuring the safety of substances and colors added to foods; ensuring the safety of foods and ingredients developed through bioprocesses; being responsible for regulatory activities in the proper labeling of foods (e.g., ingredients, nutritional health claims) and cosmetics; developing appropriate policies and regulations for the management of dietary supplements, infant food formulas, and medical foods; ensuring that cosmetic ingredients and products are safety and ensure proper labeling; monitoring and regulating post-sale practices in the food industry; consumer education and behavioral outreach; cooperative programs with state and local governments; and coordination of international food standards and safety.
2. Center for Drug Evaluation and Research (CDER):
The CDER is designed to ensure the safety and effectiveness of prescription and over-the-counter drugs by evaluating new drugs before they are introduced into the marketplace and monitoring more than 10,000 drugs on the market to ensure that the products meet the highest standards of continual updating. The Center also regulates the truthfulness of advertisements for medicines on television and radio, as well as in publications. It strictly monitors medicines to provide consumers with accurate and safe information.
3. Center for Device Safety and Radiation Health (CDRH):
The Center ensures the safety and effectiveness of newly released medical devices. That's because there are more than 20,000 companies around the world that produce more than 80,000 different types of medical devices, from blood glucose monitors to artificial heart valves. Since these products are closely related to human life, the Center also oversees nationwide after-sales service. The center also sets safety standards for products that produce radiation, such as microwave ovens, televisions and cellular phones.
4. Center for Biologics Evaluation and Research (CBER):
The Center regulates biological products that prevent and treat disease, and is therefore more complex than chemical compounds, and includes scientific research on the safety and efficacy of blood, plasma, vaccines, and so on.