SFDA consults on a newly-added licensing procedure for special use cosmetics

On August 20, 2012, SFDA started to seek public comments on a notice concerning a newly-added licensing procedure to further regulate the format and content of submitted application dossiers.

Under the notice, a new conclusion “suggest to be approved after documents supplementation” will take effect, if the following situations occur:

• the product Chinese name or Pinyin needs to be modified;
• the description and expression of the product formula need further improving or relevant literatures need to be supplemented;
• the description of some parts of production process needs to be further improved;
• product quality and safety information needs to be added;
• the instructions for use and labels need to be further improved;
• the format of reports of toxicological test, human safety evaluation test and so on needs to be further regulated;
• the expression of safety evaluation data of possible substances with safety risk in cosmetics needs to be further regulated.

In term of cosmetics administrative licensing, applicants involved in domestic and imported special cosmetics can refer to regulations, such as Requirements for Application and Acceptance of Administrative Licensing for Cosmetics and Requirements for the Application Dossiers, which are tailor-made to guide licensing application. When preparing documents, you need to be careful and pay close attention to the format, writing, expression, description as well as completeness of dossiers to avoid unnecessary follow-up supplementation.

You are invited to make comments on this notice before August 31, 2012.