导航菜单
On June 26, China's National Medical Products Administration (NMPA) issued the Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers (hereinafter the "New Provisions"), effective July 15, replacing the 2021 version. The new rules consist of 15 articles and aim to clarify regulatory boundaries, streamline administrative requirements, and encourage innovation by reducing compliance burdens for new cosmetic ingredient development.
The revised framework separates administrative and technical requirements, removing detailed technical content such as development reports, manufacturing processes, and safety assessment materials from the regulation and instead linking them to technical guidance documents. It also introduces updated post-registration and post-notification change requirements to ensure timely information updates, and simplifies procedures for changing domestic responsible persons by removing certain documentary requirements while retaining a commitment letter to confirm responsibility transfer.
On the same day, in support of the New Provisions, China's National Institutes for Food and Drug Control (NIFDC) also released the Technical Guidelines for Dossier Requirements on the Registration and Notification of New Cosmetic Ingredients (hereinafter the "Technical Guidelines"). As a general technical standard for dossier preparation, the guidelines align with the New Provisions and provide structured guidance for registrants and notifiers to conduct scientific research and submit standardized and complete application materials.
The Technical Guidelines set out requirements for scenario classification, dossier components, and basic documentation standards. A key update is the refinement of the "higher-risk functional claims" category. Compared with the previous framework, the scope has been narrowed to include only preservatives, sunscreens, colorants, hair dyes, and skin whitening agents. Functions such as anti-acne and anti-dandruff have been downgraded and removed from this category, thereby reducing documentation requirements for relevant new ingredients. The revised classification is now aligned with functions subject to registration requirements under existing regulations.
