How to Apply for China’s Sanitary Administrative License for “Three New” Disinfection Products

Background

Since the outbreak of Covid-19 epidemic, disinfection products are far more widely used in daily lives in various scenarios. Enterprises have fastened their steps in new disinfection products development.

To apply for a sanitary administrative license for “three new” disinfection products, related enterprises must:

• Judge whether your products are classified as “three new” disinfection products – the judgment can be conducted based on the Judgment Basis for Disinfectants and Sterilizing Instruments Produced with New Materials, New Process Technologies and New Sterilization Principles proposed by the National Health and Family Planning Commission;
• Apply for notification under the requirements of Provisions on the Acceptance of Application for New Disinfection Products and the Application Guide issued by the National Health Commission.

However, it is significantly difficult to notify a new disinfection product. There are uncertainties about the specific requirements, testing items, costs and application cycle for different products.

Based on the statistics from the National Health Commission (https://zwfw.nhc.gov.cn), National Health Commission has accepted 25 applications for new disinfection products notification since 2014, among which 23 applications (more than 90% of the total) were submitted in 2020, after the outbreak of the epidemic. So far, no products have been approved

What are “three new” disinfection products?

“Three new” disinfection products refer to products manufactured by using new materials, new process technologies and new sterilization principles, with the effectiveness, safety, environmental adaptability, etc. better than conventional products.

New materials are those:

• Not listed in the list of effective ingredients of disinfectant raw materials;
• Not listed as disinfection and anti-corrosion substances in the Chinese Pharmacopoeia; and
• Not listed in the current national health standards and specifications.

New process technology: refers to the change of the production technical parameters and process flow, resulting in the effectiveness, safety and environmental adaptability of disinfection products and sterilizing instruments equal to or superior than conventional products.

New sterilization principle: refers to the sterilization principle and its indicators produced by physical, chemical and biological sterilization factors or mutual synergistic effects, which are not included in the list of sterilization factors and corresponding sterilizing instruments and indicators list.

Application of sanitary administrative license for “three new” disinfection products

According to the Provisions on the Acceptance of Application for New Disinfection Products, the application process of new disinfection products is summarized as follows:

• Login the online application system of the China National Health Inspection (https://slps.jdzx.net.cn/pages/enterprise/login.jsp) and apply for notification online;
• Submit written application materials and samples to the National Health and Family Planning Commission. The National Health and Family Planning Commission then sets up a new disinfection product review committee to technically review the new disinfection products;
• The National Health and Family Planning Commission conducts administrative review according to the results of the technical review, and decide whether to approve the application or not;
• If the Health and Family Planning Commission recommends for correction, the applicant shall submit relevant materials as required within 1 year upon receipt of the Notification of Application Materials Correction, or it is deemed as giving up automatically.

At present, more than tens of thousands of disinfection products have been filed via the online filing information service platform for disinfection products. For better development, related enterprises are willing to develop and produce “three new” disinfection products. Therefore, there is no doubt that improvement on regulations and requirements concerning “three new” disinfection products can be expected soon.

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Further Information

China Disinfectant Notification