On April 8, 2022, the State Drug Administration of China published “Answers to Frequently Asked Questions (4) on Cosmetic Supervision and Management”.
***** Automatically translated from Chinese ******
In order to further standardize the supervision and management of cosmetics and protect the legitimate rights and interests of consumers, the Cosmetics Supervision Department of the State Food and Drug Administration has sorted out the common cosmetic filing annual reports and other related issues that the industry is more concerned about, and carried out one by one in accordance with my country's current cosmetics regulations and relevant technical specifications. answer:
Q: Why should an annual reporting system be set up for the filing of ordinary cosmetics?
A: Since the online filing of domestic non-special use cosmetics was implemented on June 30, 2014, the filing platform has formed more than 2.2 million product information for filing. Due to the imperfection of the original cosmetics regulatory system and the functional limitations of the old filing platform, the new "Cosmetics Supervision and Administration Regulations" (hereinafter referred to as the "Regulations") promulgated and implemented the products that had been filed before. It is still accumulating more and more on the filing platform, gradually forming "zombie" products, which brings great inconvenience to both supervision work and public inquiries. During the supervision work, it was found that some products could not even find a filer, and the main responsibility for the quality and safety of the products could not be fulfilled. These products brought hidden dangers to the health and safety of consumers, and urgently needed to be cleaned up by legal means. After the promulgation and implementation of the "Regulations", it has provided a good legislative practice in the design of the filing management system, and further clarified the main responsibility of the filing party, and the filing party should be responsible for product quality and safety according to law. Article 37 of the "Administrative Measures for Cosmetics Registration and Filing" (hereinafter referred to as the "Measures") stipulates that the filer of ordinary cosmetics shall report the production and import situation to the drug supervision and administration department responsible for the filing management every year, as well as compliance with laws and regulations, compulsory of national standards and technical specifications.
According to the "Regulations" and "Measures", the "Announcement of the State Food and Drug Administration on the Implementation of the "Regulations on the Management of Cosmetics Registration and Filing Materials" (No. 35, 2021) further clarifies that from January 1, 2022, the original registration will be approved. For ordinary cosmetics filed on the filing platform and the newly registered filing platform, the annual reporting system shall be uniformly implemented. The filer should submit the annual report of ordinary cosmetics for one year through the new registration filing platform from January 1 to March 31 each year. For filing products that fail to submit annual reports within the required time limit, the regulatory authorities will order rectification within a time limit in accordance with Article 58 of the Measures; Article 59 stipulates that the filing of related products shall be cancelled.
Q: Why do registered products need to fill in relevant information?
A: In order to standardize the production and business activities of cosmetics, strengthen the supervision and management of cosmetics, and ensure the quality and safety of cosmetics, the "Regulations", "Measures" and "Regulations on the Management of Cosmetics Registration and Filing Materials" clearly stipulate the materials that should be submitted for cosmetics registration and filing. Before the implementation of the "Regulations" and related supporting regulations, the registration and filing materials submitted by enterprises through the old platform were relatively simple. Taking domestic product filing as an example, in addition to product formula ingredient information and sales packaging, other relevant materials were archived by enterprises for future reference, resulting in Some necessary product information is missing, which brings hidden dangers to consumers' health and safety. After the implementation of the new regulations on registration and filing management, in order to improve the efficiency of registration and filing and safeguard consumers' health rights and interests, it is necessary to supplement and improve the data of registered and filed products on the old platform that are still producing and selling. It should be noted that the supplementary materials submitted on the new platform are all registration and filing materials originally filed by the enterprise for future reference, and no new requirements have been added to the registrant and filer. At the same time, taking into account the need for the integration of new and old regulations, the State Food and Drug Administration has set a reasonable transition period for registrants and filers to fill in supplementary materials. The supplementary information is used as a necessary condition to prove that the relevant products meet the "Regulations" and its supporting regulations. For products that have not been supplemented as required, production and import shall not be continued until the supplementary information is completed.
Question: What is the difference between the filing party's voluntary cancellation of the filing and the filing management department's cancellation of the filing? Do registered products that are no longer produced or imported need to be cancelled voluntarily?
A: According to the "Regulations", "Measures" and the relevant regulations for cosmetics registration and filing, for products that are no longer produced or imported, the filer can voluntarily apply for cancellation on the filing platform. The voluntary cancellation of products by the filer will not only help safeguard consumers' right to know, but also improve the efficiency of regulatory authorities. For products that apply for voluntary cancellation, if there is no violation of laws and regulations, the related products that have been listed before the cancellation of the record information can be sold until the end of the shelf life. According to Article 65 of the "Regulations", the cancellation of the record by the regulatory department is a punitive measure for illegal acts. The product whose record is cancelled by the record department shall not be listed for sale or imported from the date of cancellation of the record. If the product is still listed for sale or imported, The regulatory authorities will impose penalties in accordance with the law.
It is recommended that ordinary cosmetics filers and domestic responsible persons should sort out the products that have completed the filing as soon as possible. If they plan to continue production and import, they should submit an annual report and fill in relevant materials as required; if they are no longer produced or imported, they should take the initiative to apply for cancellation of product filing. . Considering that in the process of connecting the old and new platforms, some filers and domestic responsible persons have not yet registered their accounts on the new platform. In order to better serve the enterprise, these filers and domestic responsible persons may submit a written application to the local provincial drug regulatory authority to voluntarily cancel the filing. , and the filing management department will assist in completing the active cancellation and public information update of the filing products on the new platform, so as not to affect the continued listing, sales and import of related products.