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{"id":8866,"date":"2021-08-16T11:52:11","date_gmt":"2021-08-16T09:52:11","guid":{"rendered":"https:\/\/www.chameleon-pharma.com\/the-usa-regulatory-affairs\/"},"modified":"2022-03-28T11:36:18","modified_gmt":"2022-03-28T09:36:18","slug":"the-usa-regulatory-affairs","status":"publish","type":"page","link":"https:\/\/www.chameleon-pharma.com\/ru\/services\/pharma-regulatory-registration\/the-usa-regulatory-affairs\/","title":{"rendered":"The USA — Regulatory Affairs"},"content":{"rendered":"

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USA — Regulatory Affairs<\/span><\/h1>\n

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The USA dominates the global pharma market both in consumption and in development, securing the spot as the largest pharma market in the world<\/strong>. While barriers to commercialization for local US pharma companies are low,<\/strong> the barriers to entry for foreign pharma companies are quite high. One notoriously difficult barrier to entry for foreign pharma companies seeking to enter the US market is achieving FDA approval.<\/strong><\/p>\n<\/div>\n<\/div>\n<\/div>\n

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The regulatory body in the USA responsible for the registrations is called the Food and Drug administration.<\/a><\/p>\n

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Pharma Prescription Drugs<\/h2>\n

Having several different categories of drugs, Pharma regulatory in the USA might seem a bit overwhelming at first. The pharma\/prescription drug registration process can be complex and easy<\/strong> at the same time depending on the experience and network<\/strong> with the FDA and other local experts.<\/p>\n

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Consumer Healthcare Drugs\/OTC<\/h2>\n

In the US, Consumer Healthcare and OTC drugs<\/strong> are defined as drugs that are safe and effective for use by the general public without seeking treatment by a health professional.<\/strong>
There are two regulatory paths for the legal marketing of OTC drug products<\/strong> in the US depending on whether there already exists an OTC monograph in the USA for the OTC drug in question. OTC drugs containing ingredients that comply with an existing monograph are considered to be \u201cgenerally recognized as safe and effective\u201d<\/strong> and do not require specific FDA approval before marketing.
With our long-term experience and network with the FDA, we can offer a relatively fast registration process for Consumer Healthcare & OTC drugs in America.<\/p>\n

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Medical Devices<\/h2>\n

In the USA, Medical Devices are controlled based on a classification system. There are three classes of Medical Devices (I, II, and III)<\/strong> based on the degree of risk they present, and as the class increases, the regulatory controls also increase. Class I devices are subject to the least regulatory control and class III, the most.<\/p>\n

In addition to having different classes, different regulatory pathways also exist for bringing your medical device to the market. There are more than four different types of premarket submissions,<\/strong> and the pathway needed depends on several variables including the type of medical device and its class. A class I exemption also exists for specific devices which do not require premarket submissions.<\/p>\n

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Food Supplements\/Nutraceuticals<\/h2>\n

FDA regulates dietary supplements under a different set of regulations than those covering \u201cconventional\u201d foods and drug products.<\/strong><\/p>\n

In general, a Food Supplements\/Nutraceuticals registration process in the USA is relatively fast and easy. The FDA has a list of ingredients that are allowed in the products, along with their minimum and maximum quantities. Depending on these ingredients, the product might be exempt from registration.<\/p>\n

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Cosmetics and Derma<\/h2>\n

In the USA, The law does not require cosmetic products and ingredients, other than colour additives, to have FDA approval before they go on the market, but there are laws and regulations that apply to cosmetics on the market in interstate commerce. By definition, cosmetics in the US are \u201carticles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body\u2026for cleansing, beautifying, promoting attractiveness, or altering the appearance\u201d<\/p>\n

By law, cosmetic products in the US do not require FDA premarket approval,<\/strong> but the FDA can pursue enforcement action against products on the market that are not in compliance with the law.<\/p>\n

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Photo by John Fornander<\/a> on Unsplash<\/a><\/p>\n

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Frequently Asked Questions from clients — Regulatory Affairs<\/h2>\n

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