NMPA Announcement on Matters Concerning the Registration and Filing of Cosmetics(No. 70 of 2026)

To implement the Opinions of the National Medical Products Administration on Deepening the Reform of Cosmetics Regulation and Promoting High-Quality Development of the Industry (NMPA Cosmetics [2025] No. 18), further advance the reform of cosmetics review and approval, and promote high-quality development of the industry, the following matters concerning the optimization of cosmetics registration and filing administration are hereby announced:

1. Encouraging the First Launch of New Cosmetic Products in China

To align with high-standard international economic and trade rules and foster the “first-launch economy” in China’s cosmetics sector, where a new international cosmetic product is first launched in China, or launched simultaneously in China and other countries or regions, the registrant or filing person may, at the time of product registration or filing, submit a declaration stating that the product is being first launched in China, and is exempt from submitting proof that the product has already been marketed in the country or region where the registrant or filing person is located, or in the country or region of manufacture. For such new international cosmetic products, the sales packaging from the country or region of manufacture submitted at the time of registration or filing may be provided in the form of design artwork.

2. Exemption from Certain Animal Testing Data Requirements for Cosmetics

For special cosmetics, including hair-perming products, non-oxidative hair-dye products, and freckle-removing and whitening products that achieve their effects solely through physical coverage, as well as general cosmetics using new cosmetic ingredients, excluding children’s cosmetics, toxicological test reports are not required for product registration or filing where the manufacturer has obtained qualification documents relating to its production quality management system issued by the competent government authority of the country or region where it is located, and the results of the product safety risk assessment are sufficient to confirm product safety. In light of scientific developments, the NMPA’s technical evaluation authority for cosmetics may, through the formulation of technical guidelines, adjust the scope of products eligible for exemption from animal testing requirements as appropriate.

3. Adjustment of Safety Information Requirements for Cosmetic and Toothpaste Ingredients to Enterprise Archiving for Future Reference

At the time of product registration or filing, registrants and filing persons are no longer required to enter the safety information documents or ingredient submission codes for ingredients used in the product, and only the name of the ingredient manufacturer is required. Relevant supporting materials shall be archived by the enterprise for future reference. Where technical documents such as the Safety and Technical Standards for Cosmetics contain requirements relating to ingredient quality specifications, the registrant or filing person shall submit the relevant ingredient quality specifications or test reports in the product formula section or as part of the safety assessment documentation. The NMPA will no longer publicly disclose ingredient submission codes. For products that have already been registered or filed, where the manufacturer of an ingredient or the ingredient quality specifications are added or changed, the relevant information shall be updated and maintained, or a change application shall be submitted, in accordance with the Provisions for the Administration of Cosmetics Registration and Filing Dossiers.

4. Optimizing Safety Technical Data Requirements for Cosmetics and Toothpaste with Similar Formula Systems

(1) Where the same product registrant or filing person intends to register or file multiple products of the same brand with similar formula systems, one representative product may be selected for microbiological and physicochemical testing, toxicological testing, and human safety testing in accordance with applicable requirements, and an explanation demonstrating the representativeness of the selected product together with the above test reports shall be submitted. For the registration or filing of the other products, the above test reports may be shared, provided that an explanation of the similarity of the formula systems is submitted and the scientific validity and reasonableness of sharing those test reports are assessed and confirmed.

(2) Where products with similar formula systems are manufactured at different production sites, a representative product shall be selected separately for microbiological and physicochemical testing at each production site. At the time of product registration or filing, the corresponding microbiological and physicochemical test reports shall be submitted, while toxicological and human safety test reports may be shared.

(3) For the purposes of this Announcement, “products with similar formula systems” refers to products for which only the types or amounts of colorants, fragrances, pH adjusters, polymeric thickeners, pearlescent agents, and the amounts of corresponding formula-adjustment components such as solvents or fillers differ, while the types and amounts of all other formula ingredients are the same, and the dosage form and method of use are also the same. In light of scientific developments, the NMPA’s technical evaluation authority for cosmetics may, through the formulation of technical guidelines, adjust the criteria for determining products with similar formula systems as appropriate.

(4) Registrants and filing persons may conduct safety assessments of ingredients, risk substances, product stability, preservative efficacy, and packaging material compatibility in accordance with the assessment principles for similar products set out in the Technical Guidelines for Cosmetic Safety Assessment.

5. Simplifying Registration and Filing Data Requirements for Cosmetics and Toothpaste Following a Change of Production Site

For imported products that have already been registered or filed and are to be transferred to domestic production or have a domestic manufacturer added, or for domestic products that have already been registered or filed and are to be transferred to overseas production or have an overseas manufacturer added, where the registrant or filing person, product name, and formula remain unchanged, and there is no substantive change to the standards implemented for the product, existing toxicological testing, human safety testing, safety assessment, efficacy evaluation and other test or assessment reports may continue to be used for product registration or filing. However, microbiological and physicochemical testing shall be conducted again and the corresponding test reports shall be submitted, together with the original product registration certificate or filing certificate.

6. Expanding the Range of Accepted Test Methods for Cosmetic Efficacy Claim Evaluation

Except for efficacy claims relating to freckle-removing and whitening, sunscreen, and anti-hair loss, registrants and filing persons may independently select industry standards, international standards, technical guidelines, validated in-house methods developed by enterprises, or other appropriate methods to conduct efficacy claim evaluation testing, provided that there is sufficient scientific basis.

7. Acceptance of Shared Efficacy Claim Evaluation Test Data for Cosmetics with Similar Formula Systems

(1) Where the same product registrant or filing person intends to register or file multiple products of the same brand with similar formula systems, one representative product may be selected for efficacy claim evaluation testing. For the registration or filing of the other products, the efficacy claim evaluation test data may be shared, provided that an equivalence assessment is conducted to confirm the scientific validity and reasonableness of sharing such data. When publishing the summary of efficacy claim evaluation data in accordance with applicable requirements, the sharing of efficacy claim evaluation test data shall be stated.

(2) Efficacy claim evaluation test reports, explanations of formula-system similarity, equivalence assessments, and other relevant documentation shall be archived by the enterprise for future reference. For products involving freckle-removing and whitening, sunscreen, or anti-hair loss efficacy claims, the registrant shall submit the efficacy claim evaluation testing documentation and an explanation of formula-system similarity at the time of product registration.

(3) For the purposes of this section, “products with similar formula systems” refers to products for which only the types or amounts of colorants, fragrances, preservatives, pH adjusters, polymeric thickeners, pearlescent agents, and the amounts of corresponding formula-adjustment components such as solvents or fillers differ, while the types and amounts of all other formula ingredients are the same, and the dosage form and method of use are also the same. In light of scientific developments, the NMPA’s technical evaluation authority for cosmetics may, through the formulation of technical guidelines, adjust the criteria for determining products with similar formula systems as appropriate.

8. Simplifying Documentation for Changes to the Domestic Responsible Person for Cosmetics and Toothpaste

Where the domestic responsible person for a product is changed, it is no longer necessary to submit a letter of informed consent, stamped by the former domestic responsible person, agreeing to the change of domestic responsible person, or a court judgment or other legal document demonstrating that the change has taken effect. Only the following documents are required:

(1) The original letter of authorization for the domestic responsible person and the original notarized certificate thereof;

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

(3) A letter of commitment confirming that the proposed new domestic responsible person will assume all responsibilities of the former domestic responsible person for the products concerned, including products already placed on the market before the change.

This Announcement shall come into force on the date of issuance. Where any previously issued NMPA documents are inconsistent with this Announcement, this Announcement shall prevail.

This announcement is hereby issued.