Since the simplified filing of toothpaste ended on November 30th, EnterCo has sorted out and analyzed the simplified filing data of toothpaste, covering the following topics:
Overview of Simplified Filing Data for Toothpaste
The domestic data in this article does not include data from provincial filing platforms. As of December 1st, a total of 1,763 domestic and 105 imported toothpaste products have completed simplified filing. In terms of children's toothpaste, domestic children's toothpaste accounts for about 26% of the total filing amount, while imported children's toothpaste accounts for 18% of the total.
As for fluoride toothpaste, domestic fluoride toothpaste accounts for about 41% of the total simplified filing amount of domestic toothpaste, while the proportion of imported fluoride toothpaste is as high as 83%. Common fluorine-containing ingredients include Sodium Fluoride, Sodium Fluorophosphate, Fluorphlogopite, Stannous Fluoride, Olaflur, etc.
Toothpaste Filers and Filing Place Distribution
The simplified filing of domestic toothpaste involves 138 filers, with the filing number by the top 15 filers accounting for about 60% of the total.
The domestic toothpaste simplified filing is mostly concentrated in Zhejiang Province, accounting for about 22% of the total, followed by Guangxi Province, Fujian Province, Shanghai, and other regions.
Meanwhile, only 15 filers for imported toothpaste have completed simplified filing, with the majority completed in Guangdong Province, accounting for about 63% of the total, and about 34% in Shanghai. Only 3 products completed simplified filing in Zhejiang Province.
Domestic and Imported Toothpaste Manufacturers
As for production, about 70 domestic toothpaste enterprises participated, showing an overall trend of concentration, with the top 15 enterprises producing 70% of the total filed toothpaste.
These domestic toothpaste production enterprises are mainly concentrated in Zhejiang Province, Jiangsu Province, Fujian Province, and other regions.
In terms of imported toothpaste, only 20 enterprises participated in production, with the majority of production enterprises coming from countries and regions such as South Korea, Japan, and the United States.
The Use of Friction Agents in Domestic and Imported Toothpaste
In the selection of friction agents, domestic toothpaste tends to use Hydrated Silica, and a few products have mixed use of various friction agents such as Hydrated Silica and Silica. In addition to Hydrated Silica, imported toothpaste has a more balanced selection of friction agents.
The Use of Preservatives in Domestic and Imported Toothpaste
There is no significant difference in the use of preservatives between domestic and imported toothpaste. Most products choose to use Sodium Benzoate, followed by Benzyl Alcohol, Methylparaben, etc.
Follow-up Requirements for Toothpaste Simplified Filing
❑ The toothpaste filer shall collect and complete the corresponding product filing materials in accordance with relevant regulations and requirements before December 1, 2025.
❑ If the first batch of products is put on the market for sale before January 1, 2021, the product filing materials can be kept by the filer for future reference.
❑ If the first batch of products is put on the market for sale after January 1, 2021, the filer shall submit complete filing materials through the filing platform.
❑ Products that only require standardized adjustments in the format of the label, whose sales packaging labels for marketed products can be used during simplified filing, and product label updates shall be completed as required before July 1, 2024.
❑ Except for toothpaste products that only claim to have cleansing effects, toothpaste products with simplified filing shall also upload and publish a summary of the basis of the product efficacy claims through the filing platform before December 1, 2025.
According to the Measures for the Supervision and Management of Toothpastes, since December 1st, 2023, toothpaste filing management shall be officially implemented. Domestic toothpaste shall be filed with the provincial drug regulatory department where the filer is located before being put on the market for sale, and imported toothpaste shall be filed with the National Medical Products Administration (NMPA) before import.
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