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. According to the announcement, toothpaste manufacturers whose products have no incidents related to quality and safety, and are with comprehensive evidence of their history of safe usage can undergo simplified notification from October 1, 2023, to November 30, 2023. Products that have completed the simplified notification can continue to be imported and sold after December 1.
On the same day, NMPA released the Provisions for Management of Toothpaste Notification Dossiers. This is the first update to the notification requirements for toothpaste in over two years since the release of the draft Instructions for Toothpaste Notification Dossiers. Compared to the initial draft, the updated version provides more detailed provisions for each notification requirement, aligning closely with the requirements for cosmetics notification management. There have been some additions and deletions regarding the notification application form, basis for product naming, product formula, product labeling, product executive standards, product testing report, product safety assessment documents, and other aspects.
As revealed by the Administrative Measures on Toothpaste, starting from December 1, 2023, domestically produced toothpaste must be notified with the provincial-level drug supervision and administration department in the jurisdiction of the notification applicant before being marketed and sold. Imported toothpaste must be notified with the NMPA before importation. We are now very close to the launch of toothpaste notification management, and gaining a detailed understanding of this draft can provide significant references for preparing the notification documentation. ChemLinked is pleased to present a webinar featuring Rose Hong, sharing toothpaste notification management requirements. This aims to help you understand the requirements and remove compliance barriers.