Development Agency Assistance - FDA Profile
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Introduction to FDA Certification
Food and Drug Administration referred to as FDA
The FDA is one of the executive agencies established by the US government in the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS).
As a scientific regulatory agency, FDA's role is to ensure the safety of food, cosmetics, pharmaceuticals, biologics, medical devices, and radioactive products produced or imported in the United States. It was one of the first federal agencies to protect consumers as its primary function. The institution is closely related to the lives of every American citizen. Internationally, FDA is recognized as one of the world's largest food and drug regulatory agencies. Many other countries promote and monitor the safety of their domestic products by seeking and receiving FDA assistance.
Director of the Food and Drug Administration (FDA): food, pharmaceuticals (including veterinary drugs), medical devices, food additives, cosmetics, animal foods and pharmaceuticals, wine beverages with less than 7% alcohol content, and supervision and inspection of electronic products; products in use Or the ionic and non-ionic radiation generated during consumption affects the testing, testing and certification of human health and safety programs. According to the regulations, the above products must be FDA-approved to be safe before they can be sold in the market. The FDA has the right to inspect the manufacturer and have the right to sue the offender. According to the different product scope of supervision, it can be divided into the following major regulatory agencies:
1. Food Safety and Practical Nutrition Center (CFSAN):
The center is the most heavily funded department of the FDA. It is responsible for food safety throughout the United States, except for meat, poultry, and eggs under the jurisdiction of the US Department of Agriculture. Although the United States is the safest food supply country in the world, there are about 76 million foodborne diseases every year, and 32,000 people need hospitalization for food-borne diseases. About 5,000 people Died of foodborne illness. The Center for Food Safety and Nutrition is committed to reducing foodborne illness and promoting food safety. And promote various programs, such as the promotion and implementation of the HACCP plan
The functions of the center include: ensuring the safety of substances and pigments added to food; ensuring the safety of foods and ingredients developed through bioprocesses; and managing activities in the proper identification of foods (eg ingredients, nutritional health claims) and cosmetics; Develop policies and regulations to manage dietary supplements, infant food formulas and medical foods; ensure the safety of cosmetic ingredients and products, ensure proper labeling; monitor and regulate after-sales behavior in the food industry; conduct consumer education and behavioral expansion; Cooperative projects between state and local governments; coordination of international food standards and safety.
2. Center for Drug Evaluation and Research (CDER):
The center aims to ensure the safety and effectiveness of prescription and over-the-counter drugs, evaluate new drugs before they are marketed, and monitor more than 10,000 drugs sold on the market to ensure that products meet the highest standards of constant renewal. At the same time, the center also regulates the authenticity of advertisements for drugs on television, radio and publications. Strictly supervise drugs to provide accurate and safe information to consumers.
3. Equipment Safety and Radiation Protection Health Center (CDRH):
The center is ensuring the safety and effectiveness of newly listed medical devices. Because more than 20,000 companies around the world produce more than 80,000 types of medical devices, from blood glucose monitors to prosthetic heart valves. These products are closely related to the lives of the same people, so the center also regulates after-sales services nationwide. For some products that generate radiation, such as microwave ovens, televisions, mobile phones, etc., the center has also identified some corresponding safety standards.
4. Center for Biological Products Evaluation and Research (CBER):
The Center regulates biological products that prevent and treat diseases and is therefore more complex than chemically integrated drugs, including scientific research on the safety and efficacy of blood, plasma, vaccines, etc.
5. Veterinary Drug Center (CVM):
The center regulates animal food and medicine to ensure the practicality, safety and effectiveness of these products in maintaining life and reducing pain.
Obtaining the importance of the FDA
At present, the country is undergoing FDA certification work, and many of us in China do not understand the nature of the products currently certified. With the full opening of China's pharmaceutical market after the WTO, more and more companies are eager to get their own treasures from this international cornucopia as long as they realize the importance of the international market. However, it cannot be ignored that China's chemical industry has to be separated from the Western chemical industry for decades. Overtaking them in chemistry may still be a less realistic issue. Moreover, many differences in national policies and environmental protection have created conditions for China to become a supplier of raw materials for the world. In the past, China's chemical raw materials were exported in the form of chemical intermediates, which were simply processed by South Korea, India or other countries, such as chemical modification or other chemical routes, and even some Indian pharmaceutical companies. Simple repackaging, with the FDA certification number they have already obtained, is blatantly earning dozens of times more than the real manufacturer in China. The profit that should have belonged to the Chinese is just like this, because it lacks the number given by the FDA, and it is given to other countries in vain. Now let's talk about FDA certification. Just like China, in order to obtain sales rights in the United States, it must be approved by the US drug regulatory department, and this certification is the FDA.
In the United States, whether it is a chemical or biological agent, as long as it is recognized as a drug, according to the provisions of the US federal regulations, it must be certified by the FDA, otherwise it is considered illegal. Every country has certain standards, and the establishment of the US drug regulatory department is relatively early. The corresponding management system is also relatively complete. China's preparations want to enter the US market and need to be prepared for restructuring. However, China's APIs are increasingly recognized by internationally important pharmaceutical companies because of their low prices. The corresponding certification of APIs is the so-called DMF, which is the drug master file. In the United States, pharmaceutical companies want to legally use a drug substance that must have a DMF registration number. The registration number is the gateway to the US market for APIs.
FDA's form of application
1. Food (FOOD): refers to ordinary foods, in addition to health inspections, it is necessary to make nutrition labels. Drinks and canned foods are also subject to FCE (factory registration) and SID (product registration).
2, health food (HEALTHFOOD): also known as functional food, in addition to the import standards of ordinary foods, but also need to improve the function of the human body, but need to do nutrition labeling.
3, nutritional supplements (DIETARYSUPPLEMENT): including amino acids, trace elements, vitamins, minerals and Chinese herbal medicines, according to FDA regulations, it can reflect the Chinese medicine, health care products in the drug instructions, packaging, labels to improve human function, prevent disease The role. The FDA has strict requirements for the composition of the ingredients and the packaging and labeling.
4. Over-the-counter medication (OTC): no new drug demonstration is required, but sufficient materials must be provided to identify the active ingredients according to the regulations. After meeting the FDA's requirements for over-the-counter medications and obtaining the US Drug Registry Number (NDC), it can be marketed as a drug on the US market.
5, Cosmetics (COSMETIC): refers to rubbing, pouring, sprinkling, spraying, introducing or other means for the human body and any part of it to achieve cleaning, health care, beautification, treatment or change the appearance of the object.
6. Chinese herbal medicine for external use: It consists of pure natural plants or extracts, and it can be applied to the human body in the form of patches, lotions, suppositories, etc., which play a role in health care.
7. GMP certification: In order to legally enter the US market, domestic western medicine raw materials must apply to the US FDA for GMP certification. The US GMP certification is also a “passport” for products to enter the international market. It takes two stages
(1) DMF (DRUGMASTERFILE) was written and reported to the US FDA, and the DMF registration number was obtained.
(2) FDA officials in the United States conduct field inspections and conduct certification.
Cosmetic definition
All cosmetics sold in the United States, whether manufactured locally or imported, must comply with the Federal Food, Drug, and Cosmetic Act, the Fair Packaging and Labeling Act, and the regulations issued by the governing committees of these laws.
The Federal Food, Drug, and Cosmetic Act defines cosmetics as items that are specifically intended for use in the human body to clean, beautify, enhance attraction, or alter the appearance of the human body without affecting the structure or function of the human body. Products belonging to this definition are skin creams, lotions, perfumes, lipsticks, nail varnishes, eye creams and creams, shampoos, permanent curling agents, hair dyes, toothpastes, deodorants and any ingredients used as part of cosmetic products. Soap is mainly composed of the alkali salt of fatty acids, and the label only needs to make a statement about the human body's cleaning power, so the bill considers that soap is not a cosmetic.
Introduction to Cosmetics FDA Registration
Cosmetics are registered in the FDA unless the cosmetic contains a pharmaceutical ingredient or a trademark indicating that the cosmetic contains a drug. Or cause serious harm to the user, usually do not check the cosmetics company. Laws governing cosmetics: The FDA's legal basis for managing cosmetics is primarily the Food, Drug, and Cosmetic Act (FDCA), the Good Packaging and Labeling Act (FPLA), and other applicable regulations.
How does the FDA check cosmetics?
For cosmetics FDA does not check the product, you only need to submit a list of FDA ingredients, the FDA supervises the ingredients, and if you find any ingredients that do not meet the requirements, you will be notified to find alternative substances. By registering with the FDA. PCC (Pavereign Commerce Consulting Co., Ltd.) guarantees that customers' products will not be seized at Customs.
The FDA does not check cosmetic companies or products. They only register manufacturers and products and then file the ingredients of their products, and ask us to submit a list of products and ingredients to them; then they will analyze and determine whether our products contain harmful products. ingredient. The FDA will monitor the composition of the record once it finds any problems in the future and will notify the registered company.
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