Drug Supervision Comprehensive Makeup Document [2021] No. 264

Provincial, Autonomous Regional, and Municipal Drug Supervision and Administration Bureaus, Xinjiang Production and Construction Corps Drug Supervision and Administration Bureau, China Inspection and Quarantine Institute:
　　In order to implement the "Regulations on the Supervision and Administration of Cosmetics" and the "Measures for the Administration of Registration and Filing of Cosmetics", and to ensure the smooth and orderly progress of the registration and filing management of cosmetics during the transition period between the old and new regulations, the following matters concerning the connection between the new cosmetics registration and filing information management platform (hereinafter referred to as the new platform) and the original cosmetics registration and filing information management platform (hereinafter referred to as the old platform) are hereby notified:
　　I. The new registration and filing platform was officially launched on May 1, 2021. Cosmetics registrants, filers, and domestic responsible persons can submit applications for special cosmetics registration and handle ordinary cosmetics filing through the new platform.
　　II. From May 1, 2021, the old platform will no longer accept submissions of applications for special cosmetics registration and ordinary cosmetics filing materials.
　　For applications for special cosmetics submitted by cosmetics registrants and domestic responsible persons before May 1, 2021, the technical review department will continue to conduct acceptance, review, and approval work on the old platform in accordance with the regulations.
　　For ordinary cosmetics filing materials submitted by cosmetics filers and domestic responsible persons before May 1, 2021, the filing management department will continue to conduct supervision and inspection of the filing information on the old platform in accordance with the regulations. For domestically produced ordinary cosmetics with commissioned production, if the cosmetics filer has submitted ordinary cosmetics filing materials before May 1, 2021, and after confirmation by the filing management department of the filer's location, the product filing information will be made public.
　　III. During the post-filing supervision and inspection, if the filing management department finds that the filing materials on the old platform do not meet the requirements, it shall be handled in accordance with Article 65 of the "Regulations on the Supervision and Administration of Cosmetics"; among them, if it is necessary to order corrections, the filer shall be ordered to make corrections within a time limit. The time for the filer to complete the rectification in accordance with the requirements shall not be later than September 15, 2021. If the corrections are not made by the deadline or if the requirements are still not met after the rectification, the filing shall be cancelled by the filing management department.
　　IV. Provincial bureaus should improve the efficiency of handling registration and filing users on the new platform. For the quality management system overview, adverse reaction monitoring and evaluation system overview, etc., submitted by cosmetics registrants, filers, domestic responsible persons, and production enterprises, the formal review should focus on the format specifications and completeness of the content. Subsequently, combined with daily supervision work, supervision and inspection will be carried out in accordance with the requirements of the cosmetics production and operation supervision and management regulations.
　　V. For cosmetic enterprises that have obtained registration or completed filing through the old platform, due to the fact that the quality management system, adverse reaction monitoring and evaluation system are still being organized and improved, and the registrant's and filer's quality management system overview, adverse reaction monitoring and evaluation system overview, etc., cannot be submitted temporarily when applying for users on the new platform, provincial bureaus can conditionally approve their user applications, open temporary user permissions, and allow them to carry out relevant work on cosmetics registration and filing.
　　Cosmetics registrants, filers, and domestic responsible persons who have been granted temporary user permissions on the new platform should supplement and submit the quality management system overview, adverse reaction monitoring and evaluation system overview, etc., before January 1, 2022. If they fail to submit the supplements by the deadline, their temporary user permissions will automatically expire from January 1, 2022. After the relevant materials are organized, they can still apply for registration and filing user permissions.
　　VI. Provincial bureaus should strengthen training and publicity for cosmetics registrants, filers, domestic responsible persons, and production enterprises, guide them to carry out cosmetics registration and filing work on the new and old platforms as required, and ensure a smooth transition of cosmetics registration and filing management work.
　　
　　
　　
　　　　　　　　　National Medical Products Administration Comprehensive Department
　April 30, 2021