USA – Regulatory Affairs
The USA dominates the global pharma market both in consumption and in development, securing the spot as the largest pharma market in the world. While barriers to commercialization for local US pharma companies are low, 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.
Regulatory Body - FDA
The regulatory body in the USA responsible for the registrations is called the Food and Drug administration.
Pharma Prescription Drugs
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 at the same time depending on the experience and network with the FDA and other local experts.
Consumer Healthcare Drugs/OTC
In the US, Consumer Healthcare and OTC drugs are defined as drugs that are safe and effective for use by the general public without seeking treatment by a health professional.
There are two regulatory paths for the legal marketing of OTC drug products 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 “generally recognized as safe and effective” 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.
Medical Devices
In the USA, Medical Devices are controlled based on a classification system. There are three classes of Medical Devices (I, II, and III) 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.
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, 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.
Food Supplements/Nutraceuticals
FDA regulates dietary supplements under a different set of regulations than those covering “conventional” foods and drug products.
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.
Cosmetics and Derma
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 “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance”
By law, cosmetic products in the US do not require FDA premarket approval, but the FDA can pursue enforcement action against products on the market that are not in compliance with the law.
Photo by John Fornander on Unsplash
Frequently Asked Questions from clients – Regulatory Affairs
- FAQ - Prescription Products
- FAQ - OTC Products
- FAQ - Medical Devices
- FAQ - FS and Neutraceuticals
- FAQ - Cosmetics and Derma
- Will my existing BE studies be accepted in the USA?
- What are the important things to take understand with regards to
trademarks by the FDA? - Can my home company act as a MAH in the USA?
- What is the difference in climate zone for stability studies in the US vs. Europe and Asia?
- Is the fast track registration process possible for my products in the USA and what to be aware of?
- What are the pharma/prescription drug registration costs and time in the USA?
- How many trademarks should be suggested to the FDA’s DMEPA and why?
- How can my own company be MAH in the USA for my products?
- What are the Consumer Healthcare Drugs/OTC registration costs and time in the USA?
- How to register Herbal and Phyto OTC drugs in the USA via fast track process and why to prepare the market entry strategy before?
- What do I need to know about climate zone for stability studies in the USA?
- Is a fast track registration process available in the USA and what to make sure of?
- What is the difference between Medical Device registration and definition in US vs. Europe, Asia and throughout Latin America?
- Is my product considered a Medical Device by the laws of the FDA?
- What are the important differences in trademark registration in the USA with regards to the FDA for Medical Devices?
- Are local clinical trials necessary in the USA?
- Can my company act as a MAH in the USA?
- Climate zone for stability studies in the USA
- Is a fast track registration process available in the USA and what to be aware of?
- How difficult is the registration of Medical Devices in the USA?
- What are the Medical Devices registration costs and time in the USA?
- To which class of Medical Devices does my product belong?
- How to register claims on the pack for Food Supplements in the USA with the FDA?
- Why trademark registration in the USA can be a very difficult task with the FDA?
- Can my company act as a MAH in the USA for Food Supplements?
- What Climate zone for stability studies do I need for Food Supplements in the USA?
- How difficult is the registration of Food Supplements/Nutraceuticals in the USA?
- What are the Food Supplements/Nutraceuticals registration costs and time in the USA?
- How to register claims in the USA for Cosmetics with the FDA?
- Why is the trademark registration for Cosmetics and Derma products a big topic in the USA?
- Can my company act as a MAH in the USA or do I need a local partner for registration?
- What are the important topics about climate zone for stability studies in the USA?
- How difficult is the registration of Cosmetics in the USA?
- What are Cosmetics registration costs and time in the USA?