Requirements for Filing of Imported Non-special Use Cosmetics Won’t Be Reduced after Decentralization

Zhou Dengxue from the registration office of pharmaceuticals and cosmetics, Shanghai FDA

Since the issuance of “The decision of cancellation and decentralization of 50 administrative permission projects by the General Office of the State Council” last year, the CFDA has been endeavoring to transfer the power of approval of imported non-special use cosmetics to provincial FDAs. After initial discussions with some provincial and municipal authorities the CFDA drafted a proposal for filing of imported non-special use cosmetics this March. In September the draft proposal was opened for provincial level comments and now is about to be released for public consultation.

Zhou Dengxue from the registration office of pharmaceuticals and cosmetics, Shanghai FDA interpreted the draft proposal during CRAC 2014 (Chemical Regulatory Annual Conference) hosted by REACH24H Consulting Group on October 14. He noted that the draft proposal mainly specifies the procedures and requirements for application filing, the requirements that provincial FDAs must meet to qualify as supervisory bodies and the criteria and procedures to assess the capability of provincial FDAs. Once the draft proposal is implemented, all imported non-special use cosmetics will require online filing, review through a national unified platform by an expert panel and provincial FDAs and be subject to post-market examination for printed documentation.

Unlike domestic non-special use cosmetics, the requirements for filing of imported non-special use cosmetics won’t be reduced. Domestic companies manufacturing non-special use cosmetics need not to get approval from provincial FDAs prior to marketing their products as long as they file an online record but are subject to post-market supervision. Imported non-special use cosmetics shall get approval from provincial FDAs and are subject to more stringent review. In relation to the documentation required to support application for imported non-special use cosmetics, Zhou Dengxue explained that the documents will be the same as before but samples will be no longer needed. Furthermore, Zhou highlighted that the pre-condition for imported companies to file a record with provincial FDAs is designation of a responsible agent in China who must be a Chinese legal entity, for example REACH24H Consulting Group. What’s more, it is important to note that advice or comments of the expert panel are given for guidance only, the review results are entirely up to the provincial FDAs, according to Zhou Dengxue.