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In January 2020, China National Medical Products Administration (NMPA) released an internal announcement to initiate a pilot program for the quantitative grading management on domestic non-special use cosmetics, with a view to improving the work efficiency of filing management on non-special use cosmetics and establishing a sound administrative accountability system.
The first phase of the pilot work will be carried out in Shanghai Municipality, Chongqing Municipality, Zhejiang Province, Shaanxi Province, and Shenzhen city, Shantou city, Zhongshan city, and Jiangmen city of Guangdong Province from January 1, 2020, to June 30. Notably, the grading results issued during the pilot period will not be disclosed to the public, and will only be used to test the relevant functional modules of the filing system, and provide data for the future development of the system. Besides, NMPA also released a reference document - Guidelines for the Quantitative Classification Management of Non-special Use Cosmetics (Trial) (please contact us if the translation is required).
“4-Grade Scoring System”
As per the Guidelines, the online filing platform will automatically assign an initial score of 75 points to each filing account. Enterprises will be scored automatically and dynamically by the online filing system of domestic non-special use cosmetics, on the basis of their past compliance history, which includes product filing information, technical review, post-market surveillance and etc. According to scoring results, enterprises will be classified into the following 4 grades.
| Grade | Enterprise’s Score | Corresponding Regulatory Requirements |
| A | ≥85 | At least 10% of the filed products will be selected to conduct the technical review. |
| B | 65≤Enterprise’s score＜85
| At least 30% of the filed products will be selected to conduct the technical review. |
| C | 50＜Enterprise’s score＜65 | All filed products will be selected to conduct the technical review. |
| D | ≤ 50 |
Criteria for Earning/Deducting Points
Every time the filing applicant passes the filing, the score rises, otherwise, the score will drop. Once the enterprises are rated as “Grade C” or “Grade D”, their filing e-certificate will be marked in different colors, with the words "key inspection objects".
Detailed criteria for earing/deducting points are as follows:
| No. | Situations that earn points | Situations that deduct points (*The parts in red refer to key issues related to product safety) |
| 1 | Pass the format review of filing dossiers. | Fail to pass the format review of filing dossiers. |
| 2 | No problems are found at the post-filing inspection. | Problems irrelevant to any crucial issues such as product safety are found during the post-filing inspection. |
| 3 | - | It is found at the post-filing inspection that the product has never been produced or imported, or the product has not been produced or imported for more than 2 years and its filing has not been canceled in time. |
| 4 | - | Enterprise does not confirm whether to continue production after the filing. |
| 5 | - | The filing has been canceled by the cosmetic supervision and administration departments. |
| 6 | - | Enterprise fails to make corresponding rectifications for the opinions issued during the post-filing inspection by the deadline. |
| 7 | - | The filed product has been punished as it fails to meet the quality and safety standards in national supervision and inspection. |
| 8 | - | The testing items do not conform to the requirements specified in the Working Rules for Cosmetic Registration and Filing Testing. |
| 9 | - | Fail to provide a Certificate Of Analysis. |
| 10 | - | The safety of the product cannot be determined by the results of safety risk assessment, the product executive standard (including product technical requirements) or other dossiers. |
| 11 | - | The post-filing inspection result shows that the product shall be investigated, pulled off shelves and recalled. |
Implications for Stakeholders
Under the pilot scheme, improving the filing success rate of enterprises is the key to a high score. Hence, enterprises shall ensure full compliance with cosmetic regulations (including product ingredient, formula, packaging, labels, filing dossiers and etc.), ensure complete and sufficient product technical information and ensure timely rectifications.
The implementation of the quantitative grading management system will shift the burden of responsibility towards cosmetic enterprises and attempt to foster increased industry self-regulation which will align with an overall shift from pre-market assessment to post-market supervision.
As China is on the way to a unified regulatory regime for domestic and imported non-special use cosmetics, it can be anticipated that going forward the scope of the new cosmetic inspection approach which assigns differentiated priority to different cosmetic enterprises based on their credits will be extended to all non-special use cosmetics.
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