Pre-market Approval of New Cosmetic Ingredients in China

The demanding and drawn-out registration process of new cosmetic ingredients in China is not a task for the faint of heart. What are the major stumbling blocks that make it such tough so that only three new cosmetic ingredients have been approved by SFDA in previously 4 years? The Guidance is written to throw light upon key areas that applicants need special attentions, including determination of a new cosmetic ingredient, dossiers of vital importance, safety evaluation, exemption cases of toxicological data as well as other highlights and advices.

1. Regulatory requirements

2. Definition of new ingredients

3. Apply for pre-market approval

4. Application dossier

5. Safety criteria and evaluation

6. Toxicological profile

7. Reduced data requirements

8. Quality control

9. Must-know

10. Approved new ingredients