Less than three months after China’s National Institutes for Food and Drug Control released the draft Instructions for Cosmetic Registration and Notification Dossiers, an updated version was drafted for public comments by the NMPA on November 5, 2020 . The new draft of the Instructions for Cosmetic Registration and Notification Dossiers includes a total of 6 chapters, 57 articles, and 25 attachments, with aims to further clarify and refine the provisions in the previous draft, and shift the focus of cosmetic supervision from pre-market assessment to in-and post-market management.
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Note: Text in red indicates changes in comparison to the first draft. Strikethrough indicates a removal from first draft.
Compared to the first draft released on August 28, 2020, the major updates of the new draft are concerned with cosmetic pre-market application dossiers, such as product testing report, safety assessment document, product executive standard and etc.
Specifically, the new draft revises the naming of some documents, as shown below.
|Cosmetic Registration and Notification Dossiers|
Besides, the requirements for each of the above mentioned dossiers are further modified and refined in a bid to add clarity and increase the logicality of the regulation. Among them, the following are of great significance:
1. Product Testing Report
In this new draft, China reiterates that the relevant toxicological test items of general product can be exempted provided that the production enterprise has obtained the GMP certifications from the local government, and the product safety risk assessment results can fully verify the product safety.