On October 20, 2026, the China National Institutes for Drug Control (NIDC) released the Pre-submission Consultation Mechanism for the Registration of Cosmetics with New Efficacy (Trial). Before applying for the registration of cosmetics with new efficacy, cosmetics registrants may submit communication applications on important technical issues through the Cosmetics Intelligent Application and Review System. CIRS Group has summarized the main contents below for your reference.
1. General Principles
(1) Scope of consultation
This mechanism applies to the communication between applicants for cosmetics with new efficacy and the review department on relevant technical issues before the application dossier is submitted. A cosmetic with new efficacy intended for pre-submission consultation should have a certain research foundation, covering at least the research background, mechanism of action, current status at home and abroad, efficacy evaluation, and safety evaluation research.
(2) Consultation methods
The pre-submission consultation channels for cosmetics with new efficacy mainly include telephone consultation and meeting communication. For general technical issues related to cosmetics with new efficacy, applicants may make inquiries by telephone; for important technical issues, applicants may apply for meeting communication.
General technical issues mainly include issues on determining, according to the definition of cosmetics, whether a product is a cosmetic with new efficacy, issues on the acceptance of registration dossiers for cosmetics with new efficacy, or the application process, etc.; important technical issues mainly include issues with a certain research foundation involving the mechanism, efficacy, and safety evaluation of specific products, etc.
(3) Time limits
In principle, the reply time limits for pre-submission consultations on general technical issues and important technical issues shall not exceed 30 days and 60 days respectively. For difficult and complex issues that require technical consultation or expert meetings for further discussion, the review department may appropriately extend the time limit for holding the meeting or replying, and shall inform the applicant within the communication time limit.
(4) Nature of consultation
The results of consultations and communications are advisory and for reference only, and do not constitute part of the registration application dossier or the basis for determining whether the technical review is passed.
2. Consultation Channels and Related Procedures
(1) Telephone consultation
For general technical issues consulted by telephone, the review department generally gives a direct reply. For issues requiring further study, the review department will organize research and provide feedback by telephone, e-mail, or other means. Applicants may make inquiries via the consultation hotline within the consultation hours published on the NIDC website.
(2) Meeting communication
For important technical issues that need to be communicated through meetings, the applicant shall submit the Communication Meeting Application Form (see Annex) and relevant research materials via the Cosmetics Registration and Filing Information Service Platform. The review department shall inform the applicant of the preliminary review results within 10 days after receiving the application materials. Where the preliminary review finds that the product is wrongly defined as a cosmetic with new efficacy, that the research is insufficient, or that false materials have been submitted, the application will not be accepted; if it meets the requirements, it will be accepted.
For applications accepted for meeting communication, the review department will hold an online or offline meeting within 60 days after the application is submitted, and the meeting communication shall not exceed 45 minutes.
3. Relevant Requirements
(1) Participants in a meeting communication application should have relevant professional or research backgrounds to meet the communication needs. Participants from the review department are review personnel and relevant experts, and relevant personnel of the regulatory authority will be invited to participate when necessary.
(2) The review department shall properly keep the materials submitted by applicants and the records generated during the communication process, and strictly comply with the requirements for integrity and confidentiality.
(3) Based on the actual consultations and communications, and on the premise of not involving the applicant's trade secrets, the review department will study and sort out questions and replies of general guiding significance, formulate relevant technical Q&As or guidelines, and release them to the public.
(4) For applicants who provide false materials during the consultation, the review department will put the case on record and will no longer accept their communication applications.
(5) Provincial-level medical products administration departments with the relevant capabilities are encouraged to undertake the pre-submission consultation services for cosmetics with new efficacy.
Note: The English translation may contain deviations. In case of any discrepancy, the Chinese original shall prevail.
CIRS Reminder
This mechanism formally establishes a pre-submission consultation channel for the registration of cosmetics with new efficacy, smooths the path for technical communication between enterprises and the review department, supports the innovative R&D of cosmetics, and helps identify and resolve technical bottlenecks in advance.
It is recommended that relevant cosmetics enterprises choose appropriate consultation methods according to the type of issue; for important technical issues involving product mechanism, efficacy, and safety evaluation, the meeting communication application should be submitted via the application platform after sufficient research has been accumulated for the product.
It should be noted in particular that the feedback from pre-submission consultation is advisory and for reference only, and does not serve as the basis for passing the registration review. In addition, clear time limits are set for both meeting applications and review replies, so enterprises should reasonably plan the pace of R&D and application and allow sufficient time for communication.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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