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Interview Vol. 2 | Sharing Key Points of NMPA Internal Training on China Cosmetic Registration and Notification Regulations

The new cosmetics registration and notification regulations will be fully implemented on May 1, 2021. To help enterprises accurately understand the updated regulations, China National Medical Products Administration (NMPA) held an internal training program in April. ChemLinked regulatory analyst Winnie Xu participated in the training and brought back a lot of first-hand messages. In this interview, she shares NMPA officials' responses on the most concerning issues.
1. Any new cosmetic regulations will be released soon?

The finalized Administrative Measures on Cosmetics Labeling and Inventory of Existing Cosmetic Ingredients in China 2021 will be released before May 1. Both the labeling regulation and the IECIC 2021 are of great significance to cosmetic enterprises. In particular, IECIC 2021 will include the ingredient's highest historical use concentration. Generally speaking, NMPA will recognize that an ingredient is safe to use in cosmetics as long as the usage is lower than the highest historical use concentration.

Following that, from May to June, the post-market surveillance regulation—Supervision and Administration Measures on Cosmetics Manufacture and Operation and toothpaste-related regulations will be unveiled.

Regulations still under formulation include the Key Points of Registration and Notification Dossiers Review, Provisions on the Administration of Cosmetics Overseas Inspection, List of Permitted Whitening Ingredients in STSC, etc.

2. Imported and domestic general cosmetics can be exempted from animal testing if they have obtained the qualified GMP certificate and safety assessment report. To exempt animal testing, what kind of GMP certificate can be recognized by NMPA? Is there a template?
3. Does NMPA accept safety assessment reports issued by international institutions? Can international safety assessors carry out the safety assessment?

Webinar Recommendation:

NMPA internal training revealed a wealth of information. If you want to know all the key points of the training, you may watch ChemLinked’s webinar held on Apr. 28. Questions about efficacy evaluation, new cosmetic ingredient registration/notification and alternative methods were all answered in the webinar.

530-300-materials1x.pngAbout the Expert:


Winnie Xu

ChemLinked Regulatory Analyst

Winnie Xu is an experienced cosmetic regulatory analyst in the ChemLinked team tasked with tracking, analyzing and interpreting the latest regulatory and market changes in China, Japan, and the rest of the Asia Pacific area. She has published a number of news and articles on cosmetic regulatory compliance and involved in various industry conferences. Areas of expertise: Cosmetic Pre-Market Approval Compliance, Cosmetic Ingredient Requirements, Animal Testing and CBEC.

Previous Interview:

Interview Vol. 1 | Detailing Ingredient Submission Code Required for Cosmetic Registration and Notification

CSAR Exclusive Interview: Animal Testing, New Ingredients and What Next? (Full Transcript)

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