On November 22, 2023, China National Medical Products Administration (NMPA) unveiled the definitive edition of the Provisions for Management of Toothpaste Notification Dossiers (the Provisions). Shaped by two rounds of public consultations in January 2021 and September 2023, this final version is set to be enforced from December 1, 2023. Comprising 3 chapters, 32 articles, and 3 annexes, the Provisions specifies the responsibilities and obligations of toothpaste notifiers, the user-information-related dossiers, and the necessary documentation for initial toothpaste notification, etc.

The content includes:

• Chapter 1 General Provisions
  

• Chapter 2 Requirements for User Information Related Documents

• Chapter 3 Requirements for Notification Documents

• Annex 1 Instructions for the Preparation of Toothpaste Product Executive Standard

• Annex 2 Toothpaste Product Executive Standard (Sample)

• Annex 3 Microbiological and Physical and Chemical Testing Items for Toothpaste Notification