The Measures for Toothpaste Supervision and Administration will be formally implemented from December 1, 2023. To help filers better understand the requirements and comply with "the Measures", we have collated and translated the FAQs on the filing of toothpaste in China. Details are as follows:
What is the definition of toothpaste?
According to Article 3 of the Measures, toothpaste refers to a paste-like product applied to the surface of human teeth through friction, with the main purpose of cleaning. It highlighted that the function of toothpaste is to assist the toothbrush in rubbing against the surface of the teeth, with the main purpose of cleaning, which is basically consistent with people’s understanding of toothpaste products. Besides, the properties of toothpaste products must be "paste", which is defined in the Measures. Therefore, toothpowder, tooth cleaning gel, mouthwash, and other oral care products are not toothpaste.
Do I need to apply for filing of toothpaste?
Toothpaste needs to be filed before the product can be launched or imported. According to Article 10 of the Measures for Toothpaste Supervision and Administration, domestic toothpaste must be filed with the drug regulatory department of the province, autonomous region, or municipality where the filer is located before the product is put on the market for sale. Imported toothpaste should be filed with the National Medical Products Administration (NMPA) before being imported to China. The NMPA may entrust drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government with corresponding capabilities to implement the management of imported toothpaste filing.
What information is required for toothpaste filing?
According to Article 11 of the Measures, filers or the domestic responsible person must submit the following materials for toothpaste filing:
（1） The name, address, and contact information of the filer;
（2） The name, address, and contact information of the production enterprise;
（3） Product name;
（4） Product formula;
（5） The standards for product execution;
（6） Product label sample;
（7） Product inspection report; and
（8） Product safety assessment materials.
According to the Measures, how should toothpaste declare its efficacy?
According to Article 13 of the Measures, there should be a sufficient scientific basis for efficacy claims. Toothpaste filers must publish information such as a summary of the literature, research data, or product efficacy evaluation materials on which the efficacy claim is based, on the service platform, and accept supervision from the public.
What should be indicated on the toothpaste label?
According to Article 17 of the Measures, the toothpaste label should indicate the following contents:
(1) Product name;
(2) The name and address of the registrant and the entrusted production enterprise, and if the registrant is overseas, the name and address of the responsible person in China should also be marked;
(3) The name and address of the production enterprise, as well as the production license number of the domestic toothpaste, must be marked simultaneously;
(4) The standard number of the product execution;
(5) All components;
(6) Net content;
(7) Service life;
(8) Necessary safety warning language; and
(9) Other contents that should be marked in accordance with laws, administrative regulations, and mandatory national standards.
According to the characteristics of the product, the special usage method of the product must be labeled on the visible side of the sales packaging.
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