Heavy interpretation! Trial Implementation of Communication Mechanism of New Cosmetic Raw Materials in China Procuratorate

Release time:

2023-12-04 09:33

Since the implementation of the "Regulations on the Supervision and Administration of Cosmetics", the filing of new raw materials for cosmetics has ushered in widespread concern in the industry. Due to the lack of effective communication mechanism, the common concerns in the industry, such as the judgment of the applicability of new raw material registration and the details of data requirements, can not be effectively solved.

On November 10, 2023, NMPA issued the Announcement of the State Food and Drug Administration on Encouraging Innovation and Standardizing Management of New Cosmetic Raw Materials (No. 143 of 2023), which clearly stated that "the State Food and Drug Administration will continue to promote the construction of technical support system for new cosmetic raw materials, organize relevant technical departments to study and establish a communication mechanism for new cosmetic raw materials, and speed up the revision of technical guidelines for research on new cosmetic raw materials, strengthen the technical guidance service for the registration and filing of new raw materials for cosmetics".

On December 1, 2023, the Central People's Procuratorate issued the "Working Mechanism for Communication and Exchange of New Cosmetics Raw Materials (Trial)" (hereinafter referred to as "Communication Mechanism (Trial)") to refine the communication process. The following is a refinement of the relevant content in the exchange mechanism.

Applicable circumstances

The communication between the applicant and the review department on technical issues related to new raw materials for cosmetics during the application for registration of new raw materials, the filing of new raw materials and the submission of materials before and during the review process.

Before proposing communication, the applicant shall complete the user information registration on the cosmetics registration information service platform and conduct full research on the new raw materials to be applied for communication.

The applicant shall complete all the studies in accordance with the requirements of the Regulations on the Registration and Filing of New Cosmetic Raw Materials.

NAR New Anrun Consulting Interpretation: Before submitting an exchange request, the applicant should complete all the research as required. Based on this, one of the difficulties of the current concern in the industry (the start-up item is currently, how to confirm the applicability of the new raw material registration and filing through communication) may not be effectively resolved.

Communication Path

General technical issues related to new cosmetic raw materials can be consulted on site, by mail and telephone, and applicants for important technical issues can communicate through meetings and form a consensus with the review department.

NAR Interpretation: General technical issues are consulted through on-site, email and telephone, and only important technical issues need to be conducted through meetings.

aging

The review department shall, in principle, complete the preliminary review within 5 days after receiving the application materials. If the preliminary examination finds that the statement of the research self-examination form is inconsistent with the submitted relevant information, the information is incomplete or the definition of new raw materials is wrong, the communication application shall be directly terminated; If it meets the requirements, it shall be accepted.

If it is determined to hold a communication meeting, the review department will generally arrange to hold it within 60 working days after accepting the application in principle.

In general, the communication meeting time is 60-90 minutes, and the relevant records are formed in time. If the two parties reach an agreement, the meeting will inform the results on the spot; if the two parties do not reach an agreement, in principle, the applicant will be informed of the results within 25 working days.

NAR Interpretation: Regarding the content of the time limit, the communication mechanism (for trial implementation) only stipulates the time limit for communication meetings, and does not involve the time limit for handling general technical issues of mail communication, which needs to be further refined.

Before the "Working Mechanism for Communication and Exchange of New Cosmetics Raw Materials (Trial)" was put forward, the demand for communication paths between enterprises and regulatory authorities in the industry has been put forward many times. Although there are some gaps in the proposal of the exchange mechanism (Trial), it is undeniable that this is a great progress. We expect the regulatory authorities to issue more comprehensive guidance rules in the future to answer questions for enterprises.

The following system operation guidelines are attached for your reference.

The original text of the notice is attached:https://www.nifdc.org.cn/nifdc/xxgk/ggtzh/tongzhi/20231201190611857539.html