1. How should the safety monitoring period for cosmetic new raw material be calculated?
According to Article 19 of the Measures for the Administration of Cosmetic Registration and Filing, cosmetic new raw material that have been registered or completed filing are subject to a safety monitoring system. The safety monitoring period is three years, calculated from the date when the first cosmetic product using the new ingredient obtains registration or completes filing.
2. What are the obligations of the registrant/filer of the new ingredient and the registrant/filer of cosmetic products using the new ingredient during the safety monitoring period?
The registrant or filer of the new ingredient must establish a post-market safety risk monitoring and evaluation system for the new ingredient, conduct follow-up research on its safety, and continuously monitor and evaluate its usage and safety. They must compile and analyze the usage and safety data of the new ingredient and submit an "Annual Report" within the specified timeframe as required. If the new ingredient exhibits any of the circumstances listed in Article 22 of the Measures for the Administration of Cosmetic Registration and Filing, the registrant or filer must immediately conduct research, take necessary risk control measures, and submit a "Risk Control Report" in a timely manner.
The registrant or filer of cosmetic products using the new ingredient must promptly provide feedback to the registrant or filer of the new ingredient regarding its usage and safety. If adverse reactions or safety issues possibly related to the new ingredient arise, they must immediately take measures to control the risk, notify the registrant or filer of the new ingredient, and report to the provincial-level drug regulatory authority where they are located in accordance with regulations.
3. When should the registrant or filer of the new ingredient submit the Annual Report, and what should it include?
According to Article 21 of the Measures for the Administration of Cosmetic Registration and Filing, the registrant or filer of the new ingredient must compile and analyze the usage and safety data of the new ingredient and submit an Annual Report to the National Medical Products Administration (NMPA) no later than 30 working days before each anniversary of the safety monitoring period.
Per the Regulations on the Documentation Requirements for Registration and Filing of Cosmetic new raw material, the Annual Report generally should include: information on the registrant, filer, or entrusted production enterprise of cosmetic products using the new ingredient; information on cosmetic products using the new ingredient; supervision sampling, investigation, and recall status of cosmetic products using the new ingredient; adverse reaction monitoring data; and risk monitoring and evaluation information. Specific preparation requirements can be found in Appendix 7 of the Regulations on the Documentation Requirements for Registration and Filing of Cosmetic new raw material. The Annual Report must be submitted via the "Cosmetic Intelligent Registration and Review System."
4. Under what circumstances should the registrant or filer of the new ingredient submit a Risk Control Report, and what should it include?
According to Article 22 of the Measures for the Administration of Cosmetic Registration and Filing, the registrant or filer of the new ingredient must immediately conduct research and report to the technical review authority if any of the following situations occur:
Other countries (regions) report suspected severe adverse reactions or group adverse reaction incidents caused by the use of similar ingredients.
Other countries (regions) impose stricter usage standards, additional restrictions, or bans on similar ingredients in their cosmetic laws, regulations, or standards.
Other safety-related issues concerning the new cosmetic ingredient.
Additionally, if there is evidence indicating safety concerns with the new ingredient, the registrant or filer must immediately take measures to control the risk and report to the technical review authority.
Per the Regulations on the Documentation Requirements for Registration and Filing of Cosmetic new raw material, the Risk Control Report generally should include: basic information about the new ingredient; production and usage details; analysis of the cause of the safety issue or emergency; and the disposal measures and outcomes. Specific preparation requirements can be found in Appendix 8 of the Regulations on the Documentation Requirements for Registration and Filing of Cosmetic new raw material. The Risk Control Report must be submitted via the "Cosmetic Intelligent Registration and Review System."
5. Can additional materials or information be submitted along with the Annual Report or Risk Control Report?
According to the Regulations on the Documentation Requirements for Registration and Filing of Cosmetic new raw material, some technical documents may be submitted together with the Annual Report. For example, for new ingredients used for the first time domestically or internationally, accelerated testing data for at least three batches of the ingredient or long-term stability testing data for over one year may be submitted during registration or filing. The remaining long-term stability testing data for the shelf life may be supplemented in one go or annually along with the Annual Report.
Except for the circumstances permitted by the Regulations on the Documentation Requirements for Registration and Filing of Cosmetic new raw material, submitting other materials unrelated to the Annual Report or Risk Control Report will be deemed invalid.
