Cosmetic products in China are under the unified regulation of the National Medical Products Administration (NMPA). Its core responsibilities include the administration of cosmetic registration and notification, quality and safety supervision and inspection, post-marketing adverse reaction monitoring and handling, as well as international exchanges and cooperation.
Official Website of the Regulatory Authority: https://english.nmpa.gov.cn
Database Portal: shturl.cc/6eQcdbtl0vVFVjtZrh14b5GwAjsmrj5q9YcxHGO8jnIpwld8rubzn
Regulations on Supervision and Administration of Cosmetics (2020 Edition)
Measures for the Administration of Cosmetic Registration and Notification (2021 Edition)
1.Definition
Cosmetics refer to daily chemical products intended to be applied to the surface of the human body such as the skin, hair, nails and lips by spreading, spraying or other similar methods, for the purposes of cleansing, protecting, beautifying and modifying appearance.
2.Category-based Administration
① Special cosmetics: They shall be registered with the NMPA before production or importation.
② Ordinary cosmetics: They are subject to notification administration, and the notification formalities shall be completed before marketing or importation.
③ Toothpaste: It is administered with reference to the rules for ordinary cosmetics, with separate regulatory detailed rules.
1.Qualification Requirements for Registrants/Notifiers of Imported Cosmetics
① Enterprises or other organizations established in accordance with the law.
② A quality management system appropriate to the applied products. The manufacturing compliance certificate may be issued or recognized by the competent government authority, certification body or third party of the country/region where the manufacturer is located.
③ Capability in monitoring and evaluating cosmetic adverse reactions.
2.Core Documentation Requirements
① Safety-related information of raw materials, which can be associated via raw material filing codes, or supported by safety information documents and letters of authorization issued by raw material manufacturers.
② Letter of authorization and notarial certificate for the domestic responsible person.
③ Technical documentation such as product formulation, labeling, test reports and safety assessment reports.
Simplified Chinese
1.Exclusive Supplementary Materials for Imported Cosmetics
Cosmetic Registration and Notification Information Form and relevant supporting documents. Product category, classification code and other items shall be filled in item by item.
Information form of the registrant/notifier, and resume of the quality and safety responsible person including educational background and work experience.
Overview of the registrant/notifier’s quality management system, covering systems for supplier selection, raw material acceptance, production quality control, product retention sample, etc.
Overview of the registrant/notifier’s adverse reaction monitoring and evaluation system, including monitoring procedures and description of evaluation capability.
2.Core Product Documentation
Product name information. The Chinese name shall comply with labeling administration provisions; the foreign name shall be submitted for imported products.
Complete product formulation, including raw material serial number, standard Chinese name/INCI name, percentage content, purpose of use, sorted in descending order of content.
Product implementation standard, which shall comply with national standards, industrial standards, or enterprise-filed standards.
Draft product label including instructions, with information of the registrant/notifier and manufacturer indicated. The registration certificate number shall be marked for special cosmetics.
Product test report issued by a testing institution designated by the provincial drug administration, covering indicators such as microorganisms, hygienic chemistry and efficacy claims.
Product safety assessment materials, including raw material safety, overall product risk assessment, consumer use risk evaluation, etc.
3.Exclusive Supplementary Materials for Imported Cosmetics
For overseas registrants/notifiers: Submit the information form of the domestic responsible person and the notarized letter of authorization for the domestic responsible person.
For overseas manufacturers: Submit qualification certificates conforming to the quality management system, issued by the government or certification body of the country where the manufacturer is located. If the original copy is unavailable, notarization or embassy confirmation is required.
Certificate of marketing and sale issued by the competent government authority or industry association of the country/region where the product is marketed. It shall specify the registrant/notifier, product name, name of the issuing authority and date, with official seal and signature for confirmation.
For products exclusively designed for the Chinese market: Submit explanatory documents stating that the formulation and production process are consistent with those of overseas products.
Overseas registrants/notifiers must designate a Chinese domestic enterprise legal person as the domestic responsible person, who shall perform the following obligations:
① Handle cosmetic registration and notification procedures in the name of the registrant/notifier.
② Assist in carrying out adverse reaction monitoring, reporting and product recall work.
③ Bear corresponding quality and safety responsibilities for cosmetics placed on the domestic market.
④ Cooperate with the supervision and inspection conducted by the drug regulatory authorities.
1.Registration Flowchart
Standard registration procedure for special cosmetics: The applicant submits the registration application via the system → the acceptance authority conducts formal examination → issues an acceptance / non-acceptance / correction notice → the technical evaluation authority conducts technical review (may require supplementary materials or conduct on-site verification) → the National Medical Products Administration carries out administrative examination and approval → grants registration (issuing registration certificate) / rejects registration (issuing written decision on denying administrative license).
2.Registration Timeline and Official Fees
Notification for ordinary cosmetics: The notification is completed upon submission of full documentation, with no official review period.
Registration for special cosmetics: The official technical evaluation period is 4 to 10 months, with only one opportunity to submit supplementary materials. If on-site verification is required, the timeline will be extended accordingly.
Official fees: The NMPA does not charge any official fees for cosmetic registration or notification.