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Eight New Rules! NMPA Announcement on Matters Related to Cosmetic Registration and Filing(Draft for Comments)

Apr 01, 2026
China
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On March 31, 2026, China’s National Medical Products Administration (NMPA) issued the Announcement on Matters Related to Cosmetic Registration and Filing (Draft for Comments) and is now soliciting public comments.

Comments are solicited from March 31 to April 30, 2026. Stakeholders could submit their written comments to hzpjgyc@nmpa.gov.cn, with "Comments on the Announcement on Matters Related to Cosmetic Registration and Filing" indicated in the email subject line.

Detailed Content of the Draft

I. Encouraging First Launch of New Cosmetic Products in China

To align with high-standard international economic and trade rules and cultivate the first-launch economy in China's cosmetics sector, for international cosmetic new products that are launched first in China or simultaneously launched in China and other countries (regions), when registering or filing the products, the cosmetic registrant and filing applicant shall provide an innovative description of the product formula, manufacturing process, and other aspects, as well as a commitment statement regarding the first launch of the product in China, and are exempted from submitting proof of sales in the country (region) of origin.

II. Reducing Animal Test Data for Cosmetics

For special cosmetics including hair perming products, non-oxidative hair dyeing products, and spot-whitening products with only physical covering effects, as well as general cosmetics using new cosmetic ingredients still within the safety monitoring period and the aforementioned special cosmetics, where the manufacturing enterprise has obtained relevant qualification certificates for production quality management systems issued by the competent government authorities of the country (region) where it is located, and the product safety risk assessment results can fully confirm product safety, toxicological test reports for the products are exempted from submission during product registration and filing.

III. Changing Raw Material Safety-Related Information to Enterprise Archive for Inspection

When registering or filing products (including toothpaste), registrants and filing applicants are not required to fill in safety information files for the raw materials used in the products. Relevant materials shall be archived by the enterprise for inspection. Where technical documents such as the Safety and Technical Standards for Cosmetics have relevant requirements for raw material quality specifications, registrants and filing applicants shall submit raw material quality specifications or inspection reports together when submitting safety assessment materials. The NMPA will no longer provide various services of the raw material safety information service platform and will no longer publicize information related to raw material submission codes.

IV. Safety Technical Data for Approximate Products with Shared Formula Systems

(I) Where a single cosmetic registrant and filing applicant intends to register or file multiple products of the same brand (including toothpaste), the registrant and filing applicant may select one representative product to conduct microbiological and physicochemical tests, toxicological tests, human safety tests, and safety assessment, and submit a description of the product's representativeness and the aforementioned test and assessment reports.

When registering or filing other products, the above test and assessment reports may be shared, but a description of approximate formula systems shall be submitted, safety assessments shall be conducted for different colorants or fragrances, and the scientific rationale and reasonableness of sharing the test and assessment reports shall be evaluated and confirmed.

(II) Where the production site of approximate products with shared formula systems changes, microbiological and physicochemical tests shall be conducted anew. When registering or filing products, microbiological and physicochemical test reports shall be submitted, while test and assessment reports such as toxicological tests, human safety tests, and safety assessments may be shared.

(III) Approximate products with shared formula systems as mentioned herein refer to products where, aside from differences in the types and content of colorants, fragrances, and the content of corresponding formula adjustments, the types and content of basic formula components are identical, and the product dosage form and method of use are the same.

V. Simplifying Registration and Filing Data Requirements for Products with Changed Production Sites

For already registered or filed imported cosmetics (including toothpaste) that intend to transfer production to within China or add a domestic manufacturing enterprise, or already registered or filed domestic cosmetics (including toothpaste) that intend to transfer production overseas or add an overseas manufacturing enterprise, where the registrant, filing applicant, product name, formula, and standards implemented remain unchanged, when registering or filing products, the registrant and filing applicant may share test and assessment reports such as toxicological tests, human safety tests, and safety assessments, but shall conduct microbiological and physicochemical tests anew and submit test reports, while simultaneously submitting the original product registration certificate or filing voucher.

VI. Expanding the Acceptable Range of Efficacy Claim Evaluation Test Methods for Cosmetics

Apart from efficacy claims for spot whitening, sun protection, and hair loss prevention, for other cosmetic efficacy claims, provided there is sufficient scientific basis, cosmetic registrants and filing applicants are permitted to independently select national standards, technical specifications, industry standards, international standards, technical guidelines, or validated self-developed enterprise methods to conduct efficacy evaluation tests.

VII. Sharing Efficacy Claim Evaluation Test Data for Approximate Cosmetics with Shared Formula Systems

(I) Where a single cosmetic registrant and filing applicant intends to register or file multiple products of the same brand, the registrant and filing applicant may select one representative product to conduct efficacy claim evaluation tests.

When registering or filing other products, efficacy claim evaluation test data may be shared, but an equivalence evaluation shall be conducted to confirm the scientific rationale and reasonableness of sharing the efficacy claim evaluation test data. When publishing summaries of efficacy claim evaluation test data in accordance with regulations, the situation of shared efficacy claim evaluation test data shall be explained.

(II) Efficacy claim evaluation test reports, descriptions of approximate formula systems, equivalence evaluations, and other related materials shall be archived by the enterprise for inspection.

Where spot whitening, sun protection, or hair loss prevention efficacy claims are involved, when registering products, registrants shall submit efficacy claim evaluation test materials and descriptions of approximate formula systems.

(III) Approximate products with shared formula systems as mentioned herein refer to products where, aside from differences in the types and content of colorants, fragrances, preservatives, and the content of corresponding formula adjustments, the types and content of basic formula components are identical, and the product dosage form and method of use are the same.

VIII. Simplifying Data for Changing Domestic Responsible Person

When changing the domestic responsible person for cosmetics (including toothpaste), it is no longer necessary to submit the informed consent letter with the seal of the original domestic responsible person agreeing to the change of domestic responsible person, or the judgment documents proving that the change of domestic responsible person has taken effect. Only the following are required to be submitted:

(I) A list of products for which the domestic responsible person is to be changed;

(II) A commitment letter from the proposed new domestic responsible person to assume various relevant responsibilities of the original domestic responsible person for the products (including products already marketed before the change).

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Our Services

  • China Cosmetic Registration and Filing (including Taiwan)
  • China New Cosmetic Ingredient Registration and Filing
  • China Toothpaste Filing
  • China Cosmetic Safety and Efficacy Testing
  • Domestic Responsible Person
  • Safety Assessment Report
  • Cosmetic Raw Material Safety Information Submission Code Application
  • Formula/Label/Raw Material Review
  • Regulatory Consultation/Report/Training
  • Cosmetic Customs Clearance

Further information:

China NMPA

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