On January 21, 2026, China’s National Institutes for Food and Drug Control (NIFDC) Releases Frequently Asked Questions (FAQs) on Technical Review of Cosmetics, we have collected the latest FAQs and translated them into English for your reference.
Q1: What is the difference between registration and filing of new cosmetic ingredients?
Answer: According to the Cosmetics Supervision and Administration Regulation (CSAR), China adopts a risk-based classification system for the administration of cosmetic ingredients. New cosmetic ingredients with functions such as preservation, sun protection, coloring, hair dyeing, and skin whitening are subject to registration management. These ingredients must undergo technical review and approval, and can only be used after obtaining a registration certificate.
Other new cosmetic ingredients are subject to filing management, which must be completed before use. Filing means that the filer of the new ingredient submits relevant documentation to the drug regulatory authority for record-keeping purposes. It should be noted that the public disclosure of filed new cosmetic ingredients does not indicate official recognition of their quality or safety, and there is no such concept as "successfully approved or filed" in this context.
Q2: What are the possible outcomes of the post-filing technical review for new cosmetic ingredients?
Anawer: The technical review institution under the National Medical Products Administration (NMPA) is responsible for conducting technical verification of the documentation submitted for filed new cosmetic ingredients. If the post-filing review reveals that the submitted documentation does not meet the requirements, the filer will be ordered to make corrections within a specified period. If the deficiencies are related to the safety of the ingredient, the authority may also order a suspension of its sale and use.
If any of the circumstances listed in Article 59 of the Measures for the Administration of Cosmetic Registration and Filing apply-such as submission of false information, failure to correct deficiencies within the required timeframe, or the ingredient not falling within the scope of new cosmetic ingredients-the filing will be cancelled.
Q3: Where can filers access the post-filing technical review opinions?
Answer: After filing, the technical review institution will conduct a technical verification of the submitted documentation and perform ongoing safety and usage monitoring of the new ingredient. Therefore, filers should closely monitor updates related to the post-filing management of their ingredients. Filers should log into the Cosmetics Smart Registration and Evaluation System to regularly check for post-filing technical review opinions.
Navigation path: New Ingredient Filing → Application Management → View Documents
According to Article 60 of the Measures for the Administration of Cosmetic Registration and Filing, the official notification time is based on the timestamp of the message sent via the information service platform. When reviewing the Technical Review Opinion Notification, filers should pay close attention to the issue date and the deadline for correction, and submit the required correction materials within the specified timeframe.
Submission path: New Ingredient Filing → Application Management → Submit Correction Materials
Q4: What should be noted when submitting correction materials in response to technical review opinions?
Answer: Upon receiving the post-filing technical review opinion, the filer should carefully review and respond to each comment individually. When submitting correction materials, a statement of explanation must also be provided, detailing the modifications made in response to each specific comment. The technical review institution will grant editing permissions for the relevant sections of the filing dossier based on the nature of the comments.
If additional modifications to other parts of the dossier are necessary, the filer may apply for expanded editing permissions by providing a justification through the Cosmetics Smart Registration and Evaluation System. Application path: New Ingredient Filing → Application Management → Request Editing Permissions
After submitting the correction materials, the filer should monitor the status of the submission. If the correction materials are found to be non-compliant (e.g., failing to address all comments), they will be returned. Filers should promptly check the reason for return: New Ingredient Filing → Application Management → Reason for Return, then revise and resubmit the materials within the deadline stated in the Technical Review Opinion Notification.
Q5: If the filer is unable to complete a specific study within the required timeframe due to objective reasons such as testing cycles, how should the correction materials be submitted?
Answer: After receiving the correction notice, the filer should immediately initiate the relevant study. If, due to objective reasons such as the duration of testing, the filer is unable to complete all required studies within the specified timeframe, they must still submit correction materials on time, including a truthful explanation of the reasons for the delay.
The submission should include supporting documentation such as:
- A scientific and reasonable analysis of the issue,
- A research plan,
- Progress updates,
- Estimated completion timeline, and
- A comprehensive assessment of the potential impact on the safety evaluation of the new ingredient.
Once the study is completed, the filer must promptly submit the supplementary documentation.
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