National Medical Products Administration (NMPA) General Office Solicits Comments on the “Announcement on Matters Related to Cosmetic Registration and Filing (Draft for Public Consultation)”
Release Date: March 31, 2026

To implement the Opinions of the National Medical Products Administration on Deepening Cosmetic Regulatory Reform to Promote High-Quality Industrial Development (Guo Yao Jian Zhuang [2025] No. 18), continue advancing reform in cosmetic review and approval, and promote high-quality industrial development, the NMPA has drafted the Announcement on Matters Related to Cosmetic Registration and Filing (Draft for Public Consultation) (see Attachment 1) and now seeks public comments.

The period for public consultation is from March 31, 2026, to April 30, 2026. Relevant organizations and individuals are invited to submit feedback (see Attachment 2) to hzpjgyc@nmpa.gov.cn. Please indicate “Feedback on the Announcement on Matters Related to Cosmetic Registration and Filing” in the email subject line.

Attachments:

1. Announcement on Matters Related to Cosmetic Registration and Filing (Draft for Public Consultation)
2. Feedback Form for Comments and Suggestions

National Medical Products Administration General Office
March 31, 2026

Attachment 1
Announcement on Matters Related to Cosmetic Registration and Filing (Draft for Public Consultation)

To implement the Opinions of the National Medical Products Administration on Deepening Cosmetic Regulatory Reform to Promote High-Quality Industrial Development (Guo Yao Jian Zhuang [2025] No. 18), continue advancing cosmetic review and approval reforms, and promote high-quality industrial development, the following announcement is made regarding the optimization of cosmetic registration and filing management:

I. Encouraging First Launch of New Cosmetics in China

In alignment with high international trade and regulatory standards and to cultivate the “first-launch” economy in the Chinese cosmetic sector, for international new cosmetics launched first in China or launched simultaneously in China and other countries (regions), cosmetic registrants or filers shall provide an explanation of product innovation in formulation and process, along with a commitment statement for first launch in China. Submission of proof of sales in the country (region) of manufacture is not required.

II. Reduction or Exemption of Animal Testing Data for Cosmetics

For special cosmetics such as perming products, non-oxidative hair dyes, and physically acting whitening/freckle-removing products, as well as ordinary cosmetics and the aforementioned special cosmetics using new cosmetic ingredients under safety monitoring, where the manufacturer has obtained relevant quality management system certification from the competent authority in the country (region) of production, and the safety risk assessment confirms product safety, submission of toxicological test reports is not required during registration or filing.

III. Adjusting Safety-Related Ingredient Information for Internal Archiving

For product registration or filing (including toothpaste), registrants or filers are not required to submit safety information documents for raw materials; such documents should be archived internally. Where technical documents such as the Cosmetic Safety Technical Specifications specify requirements for ingredient quality, registrants or filers must submit the ingredient specifications or test reports along with safety assessment data. NMPA will no longer provide services via the raw material safety information platform or disclose raw material submission codes.

IV. Safety Data for Products with Similar Formulation Systems

1. Where the same registrant or filer intends to register or file multiple products under the same brand (including toothpaste), one representative product may be selected for microbiological and physicochemical testing, toxicology tests, human safety trials, and safety assessment. A statement of representativeness and the related reports may be submitted.
   Other products may share these reports, provided a statement of formulation similarity is submitted, safety evaluation is conducted for differing colorants or fragrances, and the scientific validity and reasonableness of shared reports are confirmed.
2. If the production site of similar formulation products changes, microbiological and physicochemical testing must be redone. These reports must be submitted during registration or filing; other safety assessment reports may be reused.
3. “Products with similar formulation systems” refer to products with identical base ingredients, types, and amounts, the same dosage form and usage, with differences only in types or amounts of colorants or fragrances, and corresponding adjustments in formulation.

V. Simplified Requirements for Product Registration or Filing with Change of Production Site

For already registered imported cosmetics (including toothpaste) moving to domestic production or adding a domestic manufacturer, or already registered domestic cosmetics moving abroad or adding foreign manufacturers, if registrant, product name, formulation, and standards remain unchanged, previously submitted toxicology, human safety, and safety assessment reports may be reused. Microbiological and physicochemical testing must be redone, and the original registration certificate or filing proof submitted.

VI. Expanded Acceptance of Methods for Efficacy Claim Evaluation

For cosmetic efficacy claims other than freckle-removing/whitening, sunscreen, or anti-hair loss claims, registrants or filers may, based on sufficient scientific evidence, select national standards, technical specifications, industry standards, international standards, technical guidelines, or validated internal methods to conduct efficacy evaluation trials.

VII. Sharing Efficacy Evaluation Data for Products with Similar Formulation Systems

1. For multiple products under the same brand, one representative product may be selected for efficacy evaluation trials. Other products may share data, provided an equivalence evaluation confirms the scientific validity of shared data. Public summaries of efficacy data must indicate shared data use.
2. Efficacy trial reports, formulation similarity statements, and equivalence evaluations must be archived internally. For freckle-removing/whitening, sunscreen, or anti-hair loss claims, efficacy data and formulation similarity statements must be submitted during registration.
3. “Products with similar formulation systems” here refer to products with identical base ingredients, types, and amounts, same dosage form and usage, with differences only in types or amounts of colorants, fragrances, or preservatives, and corresponding formulation adjustments.

VIII. Simplified Procedures for Change of Domestic Responsible Party

For changes in domestic responsible parties (including toothpaste), submission of consent letters or court documents confirming the change is no longer required. Only the following must be submitted:

1. Product list for the proposed new domestic responsible party;
2. Commitment from the new domestic responsible party assuming all responsibilities for products (including previously marketed products).

This announcement shall take effect from [TBD, 2026]. Previous NMPA documents inconsistent with this announcement shall be superseded by this announcement.

Special Announcement

Reference

https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/zhqyj/zhqyjhzhp/20260331163734196.html