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On October 1, 2022, with the implementation of Measures for the Management of Cosmetic Adverse Reaction Monitoring, China NMPA launched the upgraded new version of the National Cosmetic Adverse Reaction Monitoring System (hereinafter referred to as “system”) to facilitate stakeholders to submit reports. Where cosmetic registrants, notifiers, entrusted production enterprises, operators, and/or medical institutions find or learn any cosmetic adverse reaction, they shall submit a report through the adverse reaction monitoring system.
Regarding the filling-in requirements for the adverse reaction report form, the Center for Drug Reevaluation, NMPA and National Center for Adverse Drug Reaction (ADR) Monitoring sent a Guide Manual for Filling in the Cosmetic Adverse Reaction Report Form (hereinafter referred to as “Guide Manual”) to provincial centers for adverse reaction monitoring on September 23, 2022, and published it on the system’s homepage.
The Guide Manual clarifies the filling-in requirements for two types of adverse reaction reports, namely, individual cases of adverse reactions, and adverse reactions that may cause greater social impact. The content of the Guide Manual includes the items required to be filled in the report, filling-in instructions, and noteworthy points. Specifically, the items to be filled in the two types of reports are as follows.
Report of an individual case of adverse reaction | Report of adverse reactions that may cause greater social impact |
1. Report form number 2. Report type 3. Report source 4. Patient/Consumer name 5. Gender 6. Nationality 7. Age 8. Contact number 9. Mailing address 10. History of cosmetic adverse reaction 11. Medical history (e.g. dermatological history) 12. History of other allergies 13. Date the patient/consumer started using the product 14. Date of the occurrence of adverse reaction 15. Date the patient/consumer discontinued using the product 16. Subjective symptom 17. Site of skin lesions 18. Shape and configuration of skin lesions 19. Other damages 20. Supplementary description of the process 21. Preliminary judgment 22. Consequences of adverse reactions 23. Type of cosmetic products (products suspected of causing adverse reactions, products used at the same time with the suspected products) 24. Registration number of special cosmetics/notification number of general cosmetics 25. Cosmetic product name 26. Cosmetic brand name 27. Whether the product is children’s cosmetics 28. Batch number 29. Cosmetic subcategory 30. Entrusted production enterprise name 31. Cosmetic registrant/notifier 32. Chinese domestic responsible person 33. Whether the product is within the expiry date 34. Product source 35. Purchase place and platform 36. Skin patch test result of the original product 37. Skin patch test result of the ingredient 38. Other auxiliary examinations 39. Relevance evaluation items 40. Evaluation result 41. Supplement to the evaluation 42. Submitter of the report 43. The phone number of submitter of the report 44. The time when the adverse reaction was discovered or known 45. The occupation of submitter of the report 46. The unit name of submitter of the report 47. Report date 48. The unit that entrusts other units to submit the report on its behalf 49. Notes 50. Attachments 51. Cosmetics that are suspected to be unregistered or unnotified | 1. Report form number 2. Occurrence area 3. Number of people involved in the adverse reactions 4. Number of people involved in serious adverse reactions 5. Date the first patient/consumer started using the product 6. Date of the occurrence of the first adverse reaction 7. Whether the patient/consumer with the adverse reaction involved children 8. Type of cosmetic products (products suspected of causing adverse reactions, products used at the same time with the suspected products) 9. Registration number of special cosmetics/notification number of general cosmetics 10. Cosmetic product name 11. Cosmetic brand name 12. Whether the product is children’s cosmetics 13. Batch number 14. Cosmetic subcategory 15. Entrusted production enterprise name 16. Cosmetic registrant/notifier 17. Chinese domestic responsible person 18. Product source 19. Description of the general situation of adverse reactions 20. Whether it is likely to cause a greater social impact 21. Reason 22. Submitter of the report 23. The phone number of submitter of the report 24. The occupation of submitter of the report 25. The unit name of submitter of the report 26. Report date 27. Notes 28. Associate with the individual case of adverse reaction 29. View the associated individual case of adverse reaction 30. Cancel the association |
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