On March 31, 2026, the Comprehensive Department of the National Medical Products Administration (NMPA) publicly solicited comments on the Announcement on Matters Relating to the Registration and Notification of Cosmetics (Draft for Comments). This draft aims to deepen the reform of cosmetic review and approval and promote high-quality industrial development through eight optimization measures.
1. Encouraging “China First” Launches for New Products
To foster a “First-Launch Economy” aligned with high-standard international trade rules:
- For international new products launched first in China or simultaneously with overseas markets, the Certificate of Free Sale (COFS) from the country of origin is waived.
- Applicants must provide an innovative description (formulation/process) and a “China First-Launch” commitment statement.
2. Reduction and Exemption of Animal Testing Data
Toxicological test reports may be exempted under specific conditions:
- Applicable Products: Hair perming, non-oxidative hair dyeing, spot-clearing/whitening products with only physical covering effects, and general or special cosmetics using “New Ingredients” still under safety monitoring.
- Requirements: The manufacturer must hold QMS certification from its local government, and the Safety Risk Assessment must fully confirm the product’s safety.
3. Adjusting Management of Ingredient Safety Information
- During registration/notification (including toothpaste), filling out Ingredient Safety Information documents is no longer required; enterprises shall archive this data themselves for inspection.
- If technical documents specify quality standards for ingredients, the quality specifications or test reports must be submitted along with the Safety Assessment.
- The NMPA will stop providing the Ingredient Safety Information Platform and will no longer disclose Ingredient Submission Codes.
4. Sharing Safety Technical Data for Products with Similar Formulas
This clarifies the sharing of safety data among products under the same brand and registrant:
| Category | Core Rules | Site Change Requirements | Definition of Similar Formula |
| Applicable Entities: Multiple products (incl. toothpaste) of the same brand under one registrant. | Select one representative product for full safety testing; others share the report. Must submit a “Similarity Explanation” and assess safety regarding differences in colorants/fragrances. | Must re-conduct microbiological and physicochemical tests. Toxicological, human safety, and safety assessment reports can be shared. | Identical base ingredients and concentrations. Differences allowed only in types/content of colorants and fragrances. Dosage form and usage must be identical. |
5. Simplified Requirements for Production Site Changes
For registered/filed cosmetics (incl. toothpaste) changing or adding production sites:
- If the registrant, product name, formula, and executive standards remain unchanged, toxicological, human safety, and safety assessment reports can be shared.
- Only microbiological and physicochemical tests must be re-conducted.
6. Expanding Acceptance of Efficacy Evaluation Methods
Except for Spot-clearing/Whitening, Sunscreen, and Anti-hair loss, registrants may independently choose:
- National, technical, industry, international standards, technical guidelines, or validated self-developed enterprise methods for efficacy evaluation, provided there is sufficient scientific basis.
7. Sharing Efficacy Evaluation Data for Products with Similar Formulas
Sharing rules for efficacy data differ slightly from safety data sharing:
| Category | Core Rules | Data Management | Special Categories (Whitening/Sunscreen/Anti-hair loss) | Definition of Similar Formula |
| Applicable Entities: Multiple products of the same brand under one registrant. | One representative product undergoes efficacy tests; others share data. Requires equivalence evaluation. | Efficacy reports and equivalence evaluations are archived by the enterprise for inspection. | During registration, must submit efficacy test data + formula similarity explanation. | Identical base ingredients/content. Differences allowed in colorants, fragrances, and preservatives. |
8. Simplifying Changes to Domestic Responsible Persons (DRP)
When changing the DRP for cosmetics (incl. toothpaste):
- The Informed Consent Form (stamped by the original DRP) and court judgments are no longer required.
- Required Data: A list of products to be transferred and a Commitment Letter from the new DRP assuming all responsibilities of the previous DRP (including products already on the market).
Note: The public comment period is from March 31 to April 30, 2026. Please refer to the official final announcement for formal implementation measures.
