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FDA:Patron Saint of American Health

   Release date: 2019-09-29     Hits: 47     Comment: 0    
Note: Some products exported to the United States are subject to FDA inspection.FDA has a tremendous impact in the United Stat

Some products exported to the United States are subject to FDA inspection.

fda

FDA has a tremendous impact in the United States and even in the world, known as the "Patron Saint of American Health". Drug dealers and food dealers all over the world love and fear it, and its reputation and professional standards are deeply trusted by many experts and the general public. While providing good security, its strict testing and evaluation also arouse criticism from many drug dealers and food dealers, accusing them of fettering invention and innovation and obstructing people from obtaining special drugs. The biggest obstacle, and lobbying Congress to reduce FDA authority, has not affected the FDA's sacred guardianship and fulfillment of its mission and responsibilities. Today, FDA has become a powerful shield in the hearts of global food and drug consumers.


What are the FDA's institutional settings?


The United States FDA is one of the executive agencies set up by the United States Government in the Department of Public Health (PHS) under the Department of Health and Human Services (DHHS). FDA is mainly divided into two parts: testing and registration. Medical devices, cosmetics, food and drug products need FDA registration. FDA registration can be applied directly on the official website of FDA.


The FDA was founded in 1906; before that, there was no regulation of drugs in the United States, and drugs were sold through advertisements; in 1938, drugs were required to prove safety before they could be sold; in 1962, drugs were required not only to prove safety but also to prove validity before they could be sold.


Food and Drug Administration (FDA) is in charge of supervision and inspection of foodstuffs, pharmaceuticals (including veterinary drugs), medical devices, food additives, cosmetics, animal foods and pharmaceuticals, wine drinks with alcohol content less than 7%, and electronic products. Ion and non-ionic radiation produced during the use or consumption of products affects people. Testing, inspection and certification of health and safety projects. According to the regulations, the above products can only be sold on the market after they have been certified safe by FDA inspection. FDA has the right to inspect manufacturers and to prosecute offenders.


Center for Food Safety and Practical Nutrition (CFSAN)


The center is the FDA's largest workload department. It is responsible for food safety throughout the United States except meat, poultry and eggs under the jurisdiction of the United States Department of Agriculture. The Center for Food Safety and Nutrition is committed to reducing foodborne diseases and promoting food safety. And promote various plans, such as the promotion and implementation of HACCP plan.


Its functions include: ensuring the safety of substances and pigments added to food; ensuring the safety of food and ingredients developed through biotechnology; managing activities related to the correct identification of foods (such as ingredients, nutritional health statements) and cosmetics; and formulating policies and regulations to regulate dietary supplements. Infant food formula and medical food; ensure the safety of cosmetic ingredients and products, ensure correct labeling; supervise and regulate the after-sales behavior of the food industry; conduct consumer education and behavior development; cooperate with state and local governments; coordinate international food standards and safety, etc.


Center for Drug evaluation and Research (CDER)


The centre aims to ensure the safety and effectiveness of prescription and non-prescription drugs, evaluate them before they are marketed, and supervise the sale of more than 10,000 drugs in the market to ensure that products meet the constantly updated highest standards. It also monitors the authenticity of advertisements for drugs on television, radio and publications. Drugs should be strictly monitored to provide consumers with accurate and safe information.


Equipment Safety and Radiation Protection Health Center (CDRH)


The center is ensuring the safety and effectiveness of new medical devices. Because more than 20,000 companies around the world produce more than 80,000 kinds of medical devices, ranging from blood sugar monitors to artificial heart valves. These products are closely related to people's lives, so the center also supervises after-sales services nationwide. For radiation-producing products such as microwave ovens, televisions and mobile phones, the center has also established some corresponding safety standards.


Center for Biological Product Assessment and Research (CBER)


The centre regulates biological products that prevent and treat diseases and is therefore more complex than synthetic chemicals, which include scientific research on the safety and efficacy of blood, plasma, vaccines, etc.


Veterinary Drug Center (CVM)


The center supervises animal food and medicines to ensure the practicability, safety and effectiveness of these products in maintaining life and alleviating pain. The work of the Food and Drug Administration of the United States to control mad cow disease is also carried out through veterinary drug Centers'inspections of feed manufacturers. On December 19, 2007, the Food and Drug Administration of the United States announced the establishment of a database to track cloned animals in the food system, in order to enable the relevant identification procedures to be carried out effectively. The database will become part of the National Animal Identification System, which tracks all livestock raised on farms across the United States and served at tables.


For exporters, it is necessary to understand the relevant requirements of FDA and make the products meet the requirements of FDA. gmtlight strictly abides by the relevant FDA directives, delivering qualified products to the U.S. market, reducing trade risks and protecting consumers'interests. Mr. Niu tidies up, gmtlight


中文

出口美国的一些产品是要涉及FDA检查的。

FDA在美国乃至全球都有极其巨大的影响,有“美国人健康守护神”之称。全世界的药品商和食品商对其又爱又怕,它的信誉和专业水准深得诸多专家和广大民众的信赖,而其严格的检测和评估在提供良好保障的同时也引起不少药商和食品商的非议,指责其束缚了发明创新,是阻挠民众获得特效药的最大障碍,并游说国会削减FDA的权限,但这种做法并未影响FDA对其使命和职责的神圣守护与履行。时至今日,FDA已成为全球食品药品消费者心中的金刚盾牌。

FDA都有哪些机构设置?

美国FDA 是美国政府在健康与人类服务部 (DHHS) 下属的公共卫生部(PHS) 中设立的执行机构之一。FDA主要分测试和注册两个内容,医疗器械化妆品食品药品类产品需要进行FDA注册,FDA注册可以直接在FDA官方网站上进行申请。

FDA成立于1906年;之前美国的药品没有任何监管,药品通过广告进行销售;1938年要求对药品证明安全性后,才可以销售;1962年,要求药品不仅有安全性还要证明有效才可销售。

食品药品监督管理局(FDA)主管:食品、药品(包括兽药)、医疗器械、食品添加剂、化妆品、动物食品及药品、酒精含量低于7%的葡萄酒饮料以及电子产品的监督检验;产品在使用或消费过程中产生的离子、非离子辐射影响人类健康和安全项目的测试、检验和出证。根据规定,上述产品必须经过FDA检验证明安全后,方可在市场上销售。FDA有权对生产厂家进行视察、有权对违法者提出起诉。

食品安全和实用营养中心(CFSAN)

该中心是FDA工作量最大的部门。它负责除了美国农业部管辖的肉类、家禽及蛋类以外的全美国的食品安全。食品安全和营养中心致力于减少食源性疾病,促进食品安全。并促进各种计划,如:HACCP计划的推广实施等。

该中心的职能包括:确保在食品中添加的物质及色素的安全;确保通过生物工艺开发的食品和配料的安全;负责在正确标识食品(如成分、营养健康声明)和化妆品方面的管理活动;制定相应的政策和法规,以管理膳食补充剂、婴儿食物配方和医疗食品;确保化妆品成分及产品的安全,确保正确标识;监督和规范食品行业的售后行为;进行消费者教育和行为拓展;与州和地方政府的合作项目;协调国际食品标准和安全等。

药品评估和研究中心(CDER)

该中心旨在确保处方药和非处方药的安全和有效,在新药上市前对其进行评估,并监督市场上销售的一万余种药品以确保产品满足不断更新的最高标准。同时,该中心还监管电视、广播以及出版物上的药品的广告的真实性。严格监管药品,提供给消费者准确安全的信息。

设备安全和放射线保护健康中心(CDRH)

该中心在确保新上市的医疗器械的安全和有效。因为在世界各地有两万多家企业生产从血糖监测仪到人工心脏瓣膜等超过八万种各种类型的医疗器械。这些产品都是同人的生命息息相关的,因而该中心同时还监管全国范围内的售后服务等。对于一些象微波炉、电视机、移动电话等能产生放射线的产品,该中心也确定了一些相应的安全标准。

生物制品评估和研究中心(CBER)

该中心监管那些能够预防和治疗疾病的生物制品,因此比化学综合性药物更加复杂,它包括对血液、血浆、疫苗等的安全性和有效性进行科学研究。

兽用药品中心(CVM)

该中心监管动物的食品及药品,以确保这些产品在维持生命,减轻痛苦等方面的实用性、安全性和有效性。美国食品药品监督管理局控制疯牛病的工作也是通过兽药中心对饲料制造商的检查得以施行。 2007年12月19日,美国食品药品监督管理局宣布建立一个用以跟踪食物系统中的克隆动物的数据库,借以使相关鉴别程序得以有效进行。这个数据库将成为全国动物识别系统(National Animal Identification System)的一部分,该系统用于跟踪全美所有从还在农场饲养到已上餐桌的家畜。

对于出口商来说,了解FDA的相关要求,让生产的产品符合FDA的要求,是必须做的事情。gmtlight严格遵循FDA的相关指令,将符合要求的产品输送到美国市场,减少贸易风险,保护消费者利益。牛先生整理,gmtlight


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