导航菜单
On March 31, 2026, China's National Medical Products Administration (NMPA) released the Announcement on Matters Related to Cosmetics Registration and Notification (Draft for Comments), inviting public comments from March 31 to April 30, 2026. Stakeholders may submit feedback to hzpjgyc@nmpa.gov.cn.
The draft aims to implement the Opinions on Deepening Cosmetics Regulatory Reform and Promoting High-Quality Industry Development (No. 18 [2025]) and to further advance reforms in cosmetics evaluation and approval. It sets out eight key measures.
Among these, provisions related to encouraging first launches in China, reducing animal testing requirements, and simplifying changes to domestic responsible persons are particularly relevant to overseas companies seeking to enter the Chinese market.
The draft encourages first launches of innovative cosmetics in China or simultaneous global launches. In such cases, applicants are no longer required to provide proof of prior overseas marketing, provided that a statement explaining the product innovation and manufacturing process, together with a commitment to first launch in China, is submitted.
For certain special cosmetics, including perming products, non-oxidative hair dye products, and freckle-removal/whitening products with purely physical coverage functions, as well as general cosmetics and the aforementioned special cosmetics that use new cosmetic ingredients still under the safety monitoring period, toxicological test reports may be exempted at the time of registration or notification, provided that:
the manufacturer has obtained relevant GMP certification issued by the competent authority of the country (region) of origin; and
the product safety risk assessment is sufficient to fully confirm product safety.
Applicants will no longer be required to submit ingredient safety information during registration or notification. Such information shall be retained by enterprises for inspection. Where applicable, ingredient quality specifications or test reports required under the Safety and Technical Standards for Cosmetics shall remain applicable.
The NMPA will discontinue the ingredient safety information service platform and cease disclosure of ingredient submission codes.
For multiple products under the same brand by a single registrant or notifier (including toothpaste), one representative product is selected for microbiological and physicochemical testing, toxicological testing, human safety testing, and safety assessment. A statement demonstrating representativeness and the corresponding reports shall be submitted. For other products, the same data apply where formulation similarity is demonstrated. Where colorants or fragrances differ, additional safety assessment is required to justify reliance on shared data.
Where the manufacturing site changes, microbiological and physicochemical testing shall be repeated. Other test data and safety assessments remain applicable.
"Products with similar formulations" means products with identical base formulation, differing only in colorants, fragrances, or minor adjustments, and sharing the same product form and intended use.
Where a manufacturing site change occurs without changes to key product attributes, existing safety assessment data remain applicable. Microbiological and physicochemical testing is required, together with submission of the original registration certificate or notification documentation.
For the purpose of this provision, manufacturing site changes include:
transfer of imported cosmetics or toothpaste to manufacturing within the mainland of China, or addition of a manufacturer within the mainland of China; and
transfer of registered or filed domestic products to manufacturing outside the mainland of China, or addition of a manufacturer outside the mainland of China.
Except for certain functional claims (freckle removal/whitening, sun protection, and hair loss prevention), applicants may use scientifically justified methods for efficacy evaluation, including national, technical, industry, or international standards; technical guidelines; or validated in-house methods.
For multiple products under the same brand by a single registrant or notifier, one representative product is selected for efficacy claim substantiation testing. A statement demonstrating representativeness and the corresponding test report shall be submitted. For other products, the same data apply where formulation similarity is demonstrated. Where colorants, fragrances, or preservatives differ, an equivalence assessment is required to justify reliance on shared efficacy data. The summary of efficacy claim substantiation shall indicate the use of shared data.
Efficacy test reports, formulation similarity statements, and equivalence assessment documents shall be retained by the enterprise for record-keeping and inspection. For products with claims related to freckle removal/whitening, sun protection, or hair loss prevention, efficacy claim substantiation data and a formulation similarity statement shall be submitted at the time of registration.
"Products with similar formulations" means products with identical base formulation, differing only in colorants, fragrances, preservatives, or minor adjustments, and sharing the same product form and intended use.
The draft simplifies documentation requirements for changes to the domestic responsible person by removing certain supporting documents (notarized consent from the original domestic responsible person; and legal documents evidencing the effectiveness of the change) . Instead, only a list of products involved, and a commitment letter from the proposed domestic responsible person undertaking all relevant responsibilities, including those arising prior to the change, are submitted.
