Toothpaste brands marketing in China: Don’t miss out on the opportunity to take advantage of the simplified notification procedure with the China NMPA. But be wary – the deadline is swiftly approaching. All toothpaste brands must finalize their simplified notification by December 1st, 2023. If missed, brands may face the risk of delisting and an import ban to China.
The China State Administration of Market Regulation (SAMR) rolled out the “Measures for the Supervision and Administration of Toothpastes” on March 23, 2023. This regulation will be active from December 1, 2023.
In a follow-up to the regulation, the National Medical Products Administration (NMPA) made an announcement on September 25, 2023, titled “Announcement Regarding the Implementation of Toothpaste Regulatory Regulations and Simplification of Filing Dossier Requirements for Marketed Toothpastes (No.124/2023).” This grants existing toothpaste brands in China the privilege to send in a simplified notification before the enforcement of a more stringent management system, in line with the cosmetics regulations. This interim period gives brands a buffer to transition seamlessly to the updated cosmetic standards, which mandate comprehensive testing, safety evaluations, and efficacy assessments.
From October 1, 2023, to November 30, 2023, toothpaste applicant can submit the following simplified information through the filing platform for the filing of already marketed toothpaste products:
- Applicant's basic information, including the company name, address, contact information, etc. If production is outsourced, the name, address, and contact information of the actual manufacturer should also be submitted.
- Basic product information, including the product name, formula, pictures of product marketed packaging label, etc.
- Relevant documents proving that the product has a safe usage history in China, including but not limited to:
1.) Production and ingredient records since the product was marketed
2.) Sales invoices
3.) Customs declaration (imported products)
4.) Inspection reports
5.) Commitment of product safety and authenticity of filing information, etc.
The authority will publish the filing information to public on the official website within 5 workdays after submission.
To ensure compliance, brands must prepare a product filing dossier aligning with the new regulations before December 1, 2025. Depending on the product’s initial launch date, the dossier submission protocol varies.
Brands should also note label requirements. If only label format adjustments are necessary, existing labels can be used during the simplified filing. Nonetheless, a label update is mandatory by July 1, 2024.
Additionally, by December 1, 2025, toothpaste products submitted for simplified filing, except those solely marketed for cleaning, must disclose a summary of the basis for their efficacy claims through the filing platform.
The Bottom Line: This policy streamlines the filing process for toothpaste products with an established safety profile, distinguishing between novel and existing products, and grants brands the needed time to align with cosmetic regulations.
For further insights and filing assistance, reach out at info@accestra.com.
