China new cosmetic ingredients communication channel (Trial) was introduced by the National Institute for Food and Drug Control (NIFDC) on December 1, 2023.
In the dynamic world of cosmetics, innovation is key to staying competitive. Companies continually strive to develop new cosmetic ingredients that meet consumer demands whilst adhering to regulations. To foster innovation and ensure regulatory compliance, the NIFDC has introduced this trial communication channel to facilitate exchanges between new cosmetic ingredient applicants and the NMPA’s technical evaluation department.
Encouraging Innovation and Regulation Compliance
- The primary goal of this communication channel is to encourage and support research and innovation in cosmetic ingredients.
- It seeks to establish a structured procedure of communication between applicants and the NMPA’s technical evaluation department.
- This initiative aligns with regulations outlined in the “Cosmetic Supervision and Administration Regulations” and the NMPA’s announcement on encouraging innovation and standard management of cosmetic ingredients (No. 143 of 2023).
Understanding the Communication Process
- In this trial communication channel, communication refers to the dialogue between applicants and the technical evaluation department regarding technical issues related to cosmetic ingredients.
- This dialogue can take various forms, including in-person meetings, email correspondence, and telephone discussions.
- For significant technical matters, applicants will have the opportunity to engage in meetings to achieve consensus with the evaluation department.
Preparing for Communication
- Before initiating communication, applicants must register their user information on the Cosmetic Registration and Filing Information Service Platform.
- They are also expected to conduct thorough research on the cosmetic ingredients they wish to discuss.
- Additionally, applicants must complete all research requirements according to the “Management Regulations for the Registration and Filing of Cosmetic New Ingredients” and submit a “Self-Checklist for Cosmetic New Ingredient Research” along with their application.
The Review Process
- Upon receiving the application, the evaluation department conducts an initial review within 5 working days.
- If discrepancies, incomplete information, or incorrect ingredient definitions are discovered during this review, the application is terminated. Otherwise, it is accepted for further communication.
- Both applicants and evaluation department representatives must possess the necessary expertise to facilitate effective communication.
- The evaluation department’s team includes assessors and consulting experts. If needed, relevant personnel from the regulatory authority may be invited.
Efficiency and Quality
- To ensure the quality and efficiency of communication meetings, evaluation department representatives will thoroughly review relevant ingredients in advance and form preliminary opinions.
- Communication meetings are generally scheduled within 60 working days after receiving the application.
- The meetings follow a predefined agenda, and the discussion focuses on the listed topics.
- Typically lasting 60-90 minutes.
- If consensus is reached during the meeting, the outcome is communicated immediately. If not, the applicant is informed of the decision within 25 working days.
- The evaluation department may request additional communication if they believe further discussion on technical issues or research is necessary. However, all communication should adhere to agreed-upon timelines and methods.
Transparency and Integrity
- Transparency and integrity are crucial aspects of this mechanism. Any private interactions between the evaluation department and applicants are strictly prohibited.
Record Keeping and Consequences
- The evaluation department is responsible for maintaining records of all communication channel applications, self-checklists, related materials, and communication records.
- While communication channel outcomes can be used for reference during subsequent document reviews, they do not influence the registration and filing approval process.
Consequences of Non-Compliance
- Applicants providing false information, repeatedly failing to proceed with registration or filing after communication (except for quality and safety reasons), or not cooperating with the communication process will no longer have their applications for communication channel accepted..
- The evaluation department regularly updates the public on the status of communication activities. Communication opinions with broad implications may be published as technical Q&A or guidance principles, provided they do not disclose applicants’ trade secrets.
Read the original NIFDC announcement on new cosmetic ingredients communication channel.
For more information about new cosmetic ingredients in China, please refer to these recent blog posts:
- China new cosmetic ingredients research guidelines – draft for comments.
- New cosmetic ingredients filed for China registration: 77 in total as of July 2023.
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