The Provisions for Registration and Filing of Cosmetics

Section III Registration Administration

Article 38 Before a special cosmetic is produced or imported, the registrant shall submit the application dossiers as required by the NMPA.

If the procedures and time limit for the registration of special cosmetics are not stipulated, the regulations on registration of new cosmetic ingredients in these Provisions shall be applied.

Article 39 The technical assessment agency shall, within 90 working days from the date of receiving the application dossiers, organize the technical evaluation in accordance with the requirements of technical evaluation, and deal with it respectively according to the following circumstances:

(1) If the application dossiers are true, complete, and able to prove that the product safety and quality control, product formula and product executive standards are reasonable, and meet the requirements of current laws, administrative regulations, mandatory national standards and technical specifications, a technical assessment conclusion of pass shall be made;

(2) If the application dossiers are untrue and unable to prove the product safety and quality control, product formula and product executive standards are reasonable, or do not meet the requirements of current laws, administrative regulations, mandatory national standards and technical specifications, a technical assessment conclusion of not pass shall be made; and

(3) If supplementary documents are required, the registrant shall be notified of all the content to be supplemented once; the registrant shall provide supplementary documents at one time as required within 90 working days, and the evaluation time limit shall be recalculated after the technical assessment agency receives the supplementary documents; if the supplementary documents are not submitted within the specified timeline, the technical assessment agency shall make a technical assessment conclusion of not pass.

Article 40 The NMPA shall, within 20 working days from the date of receiving the technical evaluation conclusions, review the legality, standardization and completeness of the technical evaluation procedures and conclusions, and decide whether to approve registration.

The service agency shall issue the cosmetic registration license or the decision letter of non-registration to the registrant within 10 working days from the date when the NMPA makes the administrative decision. The registration license for cosmetics is valid for 5 years.

Article 41 If the registration items of the registered special cosmetics are changed, the NMPA shall implement classified management according to the degree of influence of the changed items on product safety and efficacy:

(1) If there are changes in matters that do not involve safety or efficacy claims, the registrant shall promptly report to the NMPA for filing;

(2) If there are changes in safety-related matters, as well as substantial changes in the production process, efficacy claims, etc., the registrant shall submit an application for change for the registered product to the NMPA; and

(3) If the product name, formula, etc. changes, which constitutes a new product in essence, the registrant shall re-apply for registration.

Article 42 If the registered product is no longer produced or imported, the registrant shall take the initiative to apply for cancellation of the registration license.

Section IV Renewal of Registration License

Article 43 If the registration license of a special cosmetic expires and requires a renewal, the registrant shall apply for the renewal of the registration within 30 to 90 working days before the expiration of the product registration license, and promise to comply with the requirements of mandatory national standards and technical specifications. The registrant shall be responsible for the authenticity and legality of the submitted documents and promises made.

If the application for renewal of registration is not submitted within the time limit, its application for renewal of registration will no longer be accepted.

Article 44 The service agency shall conduct a formal review of the application dossiers within 5 working days after receiving the application for renewal, accept the application if it meets the requirements, and issue a new registration license to the applicant within 10 working days from the date of acceptance. The validity period of the registration license shall be recalculated from the day after the expiration date of the original registration license.

Article 45 The drug regulatory department shall supervise the activities related to the application dossiers and promises of the special cosmetics that have been renewed for registration. If the supervision and inspection or technical evaluation reveals that there is a circumstance that does not meet the mandatory national standards or technical specifications, the cosmetic registration license of special cosmetics shall be revoked according to law.

Chapter IV Supervision and Administration

Article 46 The drug regulatory department shall supervise and inspect the activities of registration and filing conducted by the registrant and the filing person in accordance with the provisions of laws and regulations, and may conduct extended inspections of the entities involved when necessary. The relevant entities and individuals shall cooperate, and shall not refuse the inspection or conceal relevant information.

Article 47 During the process of registration technical evaluation, the technical assessment agency may notify the inspection agency to carry out on-site inspection as needed. Domestic on-site inspections should be completed within 45 working days, and overseas on-site inspections should be implemented in accordance with relevant provisions on overseas inspections. The time for on-site inspection is not included in the time limit of technical evaluation.

Registrants shall cooperate with the on-site inspection, and provide samples as required when sampling and testing is required.

Article 48 After obtaining the registration license of special cosmetics, the registrant shall upload the picture of the marketed product label to the information service platform for public inquiry before the products are put on the market.

Article 49 The transfer of cosmetic registration license is prohibited. The change application of registration shall be followed in accordance with these Provisions, if the registrant is changed to a new company or another organization due to company merger or split causing the cancellation of the original registrant as an entity.

The altered registrant shall comply with requirements of a registrant in these Provisions and shall be responsible for the quality and safety of the products already on the market.

Article 50 Where progress in scientific research changes the understanding of the safety of cosmetics and cosmetic ingredients, or there is evidence to show that certain cosmetics and cosmetic ingredients may be defective, the drug regulatory departments undertaking registration and filing may order the registrants and filing persons of cosmetics and new cosmetic ingredients to carry out safety re-evaluation or may directly organize relevant ingredients and cosmetics enterprises to conduct a safety re-evaluation.

Where the re-evaluation results show that the safety of cosmetics and cosmetic ingredients cannot be ensured, the original registration department shall withdraw the registration, the filing department shall cancel the filing, and the drug regulatory department under the State Council shall include such cosmetic ingredients in the list of ingredients banned for use in the production of cosmetics, and make it known to the public.

Article 51 Where progress in scientific research, risks monitoring on cosmetics safety and evaluation shows that there are safety risks in certain cosmetic ingredients, and such risks could be eliminated by setting the use scope and conditions of ingredients, such use restrictions and conditions of ingredients should be clarified in the inventory of existing cosmetic ingredients.

Article 52 If the drug regulatory department responsible for registration and filing administration is unable to contact the registrant, the filing person, or the domestic responsible person through the registration and filing information, it may list the registrant, filing person, and domestic responsible person on the information service platform as key targets for supervision and make an announcement on the platform.

Article 53 The drug regulatory department shall implement risk classification management based on the operation of quality control system, post-filing supervision, and post-marketing supervision and inspection status of the filing persons, the domestic responsible person and the cosmetic manufacturer.

Article 54 The drug regulatory departments, technical evaluation, on-site inspection and testing agencies and their staff shall strictly abide by the laws, regulations, rules and the relevant provisions of the NMPA to ensure that relevant work is scientific, objective and impartial.

Article 55 Without the consent of the registrant and the filing person, the drug regulatory departments, professional technical institutions and their staff, and those who involved in the evaluation shall not disclose the business secrets, undisclosed information or confidential business information submitted by the registrant or filing person, except as otherwise provided by law or involving national security or major public interests.