What You Should Know about Toothpaste Filing in China

On March 23, 2023, China’s State Administration for Market Regulation (SAMR) officially published the Measures for Toothpaste Supervision and Administration, which already took effect on December 31, 2023. On September 25, 2023, China announced to simplify the filing documents requirements for marketed toothpaste. To help enterprises better complete the toothpaste filing, China Oral Care Industry Association released a notice to explain some issues regarding toothpaste filing.

Details are as follows:

1. Changes and supplements to the information for the simplified filing of marketed toothpaste products

Recently, the toothpaste filing system has been upgraded. Information change for toothpaste products subject to simplified filing is still available in the system. Related enterprises are allowed to supplement and modify the original filing materials separately in the updated system, but cannot directly replace the original filing materials.

2. About the new toothpaste filing system

The new product filing system has now been launched. Relevant enterprises are suggested to prepare the filing materials as soon as possible.

3. About the methodological standards for efficacy verification

The efficacy verification method for newly launched products can refer to the current industry standard WS/T326 before the new standards are introduced. Fill in the name of the standard in relevant columns. 

4. Safety assessment

(1) Considering that the ingredients listed in the Catalogue of Used Toothpaste Ingredients (Association Edition) have a usage history of three years or more and the highest usage, they can be referenced by enterprises when conducting product safety assessments. If there are any changes thereafter, the China Oral Care Industry Association will make timely adjustments.

(2) Ingredients that are not listed in the "Catalogue of Used Toothpaste ingredients (Association Edition)", if they are marketed products and have undergone simplified filing, please continue to follow up on the adverse reactions and other records of the products; If the ingredients have not yet been used in toothpaste, please follow the Provisions on the Management of Toothpaste Registration and Filing Data for corresponding filing or registration work.

(3) The association is currently communicating and negotiating with relevant parties regarding the methods and scope of application of the oral mucosal irritation test. If there are any conclusions, we will inform everyone in a timely manner. 

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