Outbreak, disposable export disinfection liquid soap?
Disposable disinfectant hand sanitizer
exports the United States should be pay attention to?
New crown since pneumonia outbreak, the Chinese government at all levels thoroughly study and apply xi general secretary's important speech spirit, in accordance with the firm faith, in the same boat, scientific control, precise ShiCe general requirements, epidemic prevention and control work in an all-round way.
So far, China's epidemic situation continued to be good, to achieve 'zero' cases of the more than ten provinces.
However, the new pneumonia has spread abroad, in Europe and the United Nations also make up 'mask panic'.
Not only that, disinfectant, goggles, disinfectant, epidemic prevention items also became JinQiaoHuo.
The U. S. centers for disease control and prevention (
Said to hand clean is to avoid illness and one of the most important steps to prevent the transmission of infectious diseases, disposable disinfectant hand sanitizer must contain at least 60% alcohol, mainly because of containing at least 60% of the alcohol in the general case can kill most known microbes.
In response to the new crown pneumonia outbreak, recently started hoarding a large number of americans without washing your hands fluid, liquid soap products in some states began to appear in short supply.
The CNBC reported Wednesday, according to market research firm Nielsen according to the latest data, between February 29th February 22 solstice, hand sanitizer 313 total sales growth in the United States.
Hand sanitizer in the United States have a bottle of is hard to find, in order to make Chinese enterprises hand sanitizer products to enter the American market as soon as possible, xu group will now be disposable disinfectant hand sanitizer export compliance requirements to arrange the following in the United States.
In the United States, the local disinfection of disposable disinfectant hand sanitizer belongs to over-the-counter namely OTC (
Drugs, by the us food and drug administration (
OTC drugs have a totally different from prescription drug regulatory management system that is 'OTC monograph' (
The establishment of the OTC monograph mainly divided into three steps: the first step is appointed by the FDA expert advisory committee review active ingredients, determine whether it is safe and effective,
The second step is according to the opinion of the committee of experts to the FDA, the public opinions and new data, to review of active ingredients, and publish the tentative monograph (
The third step is to use proved safe and effective for many years, release the final OTC monograph (
OTC monograph, included in the federal administration law (
联邦法规的代码:331 - 21 CFR部分
The FDA after assessment, 28 kinds of active ingredient (ban
Detailed list see attachment 1)
Used for disinfection of disposable hand sanitizer, mainly because most tested antibacterial products containing the 28 kinds of active ingredients, and failure to review by OTC drugs, including benzene ethoxy ammonium chloride and triclosan.
FDA review main active ingredient for OTC drugs, if the active ingredient has been included in the FDA's OTC monograph management system, the sale, it does not need to be approved by the FDA.
But the address should be performed in the FDA factory production enterprises registered, comply with good manufacturing practices (
And the requirements of the relevant drug registration.
To and in accordance with the GMP requirements of the standard production of OTC monograph, obtained the national drugs registration number (
English label, and have to meet the requirements, meet the regulatory requirements of SDS, and in conformity with the relevant regulations of the import and export requirements.
The above work ready, the next step is to enter the market, OTC products into the market approach mainly depends on the dealer, so you also require companies outside the United States need to have their own distributors in the United States.
If active ingredient has not listed in the OTC monograph system, will need to be approved by the FDA approval, the application methods mainly include: citizens request (
TEA, declaration, declare new drug applications, etc.
To sum up, if enterprises want to export the hand sanitizer active ingredient has been listed in the OTC monograph system, the FDA has been done in the factory registration, and the product conforms to the drug production quality management standard (
And compliance program is relatively simple, relatively easier to enter the American market.
Xu group in the field of disinfection products compliance with years of experience in dealing with, in the United States, Europe, Ireland, South Korea and other places have branch offices, can provide for the domestic and foreign enterprises in China, the United States, the European Union, South Korea and other countries disinfection liquid soap compliance services, enterprise if necessary, can feel free to contact us.
Tags: disposable disinfection liquid soap exports
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