BackgroundCurrently, toothpastes in China are regulated under a simplified management scheme, allowing them to enter the market if they meet applicable national and industry standards. However, starting from December 1, 2023, toothpastes will be subject to the Administrative Measures on Toothpastes, which is a more rigorous management approach aligned with general cosmetics regulations. This means that in the future toothpastes will require notification, testing, safety assessment, efficacy evaluation, and new ingredient application. |
On September 25, 2023, China National Medical Products Administration (NMPA) issued an announcement regarding the implementation of toothpastes supervision regulations and the simplification of notification document requirements for toothpastes already available in the market. 1
Acknowledging the current state of the toothpaste industry, the announcement:
Highlights the primary responsibility of the toothpaste notifier, who is accountable for product quality, safety, and efficacy claims. Before initiating the product notification, the notifier must submit relevant documents through the toothpaste notification information service platform to open a user account;
Introduces simplified notification document requirements for toothpastes that have been on the market before December 1, 2023, have no incidents related to quality and safety, and are with comprehensive evidence of their history of safe usage. This streamlined approach aims to facilitate the smooth implementation of the new regulations.
Timeline of Compliance Obligations for Marketed and Unmarketed Products
As per the announcement, the compliance obligations and related requirements for marketed and unmarketed toothpastes are summarized in the table below.
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