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Takehome:
Registration of imported cosmetics will be entirely replaced by filing from Nov. 10. Authorization of a domestic responsible person is critical after the reform.
Enterprises with accepted registration application to NMPA can either continue it or withdraw the registration and replace with filing.
Renewal and change of obtained registration certification are subject to mandatory filing requirements.
Animal testing data is necessarily required to be provided to substantiate cosmetic safety.
On Nov. 9, 2018, China National Medical Products Administration (NMPA-Subordinate to SAMR) officially announced that registration of first-imported non-specials cosmetics will be entirely replaced by filing management nationwide from Nov. 10 in accordance with the State Council’s notice of Advancing the Reform of “Separating Certificates from Business License”, confirming what ChemLinked has exclusively reported earlier.
The announcement serves as the preliminary enforcement rules and also instructs cosmetic stakeholders on post-reform regulatory requirements. Key stipulations are as follows:
1. Foreign manufacturers shall designate a domestic responsible person (RP) and authorize the RP to file a record via online filing system at the administration website of NMPA prior to import. Only after obtaining a filing certification on the system will the product be permitted to be imported and distributed. |
ChemLinked Interpretation:
Filing of first imported non-specials cosmetics will be mandatory and require designation of an RP a priority task.
2. Domestic responsible person located in the pilot zones capable of filing management including Tianjin, Liaoning, Shanghai, Zhejiang, Fujian, Henan, Hubei, Guangdong, Chongqing, Sichuan and Shanxi shall complete filing to provincial administration for market regulatory (previous provincial FDA) after online filing application and dossiers submission. Domestic responsible person located outside pilot zones in China shall complete filing to NMPA after online dossiers submission. |
3. Domestic responsible person intending to import a filed product from more ports outside of designated location are required to supplement relevant information about the new import port and the consignee through online filing system. |
ChemLinked Interpretation:
Firstly, in practical implementation the operation of the updated filing system is essentially the same as the previous filing system. Secondly, there is no restriction of import port and cosmetic are allowed to be imported from different ports rather than being confined to RP’s registration port, which means the electronic filing certification will have the same force as the paper registration certificate. Further, currently the filing certification has no limit of validity (registration certificate: 4-year validity) provided the authorization of RP is valid.
4. Manufacturers of imported cosmetics shall conduct work concerning the authorization of domestic responsible person, user registration of online system, submission of filing dossiers, printing of obtained certification and etc. in accordance with the previous CFDA’s notice Procedures of Filing Management for First Import Non-special Use Cosmetics through Shanghai Pudong New Area (Interim).
Matters in regards to testing report of first imported non-special use cosmetics and the commission manufacture between domestic and overseas enterprises shall refer to the requirements under “Notice of Inspection Report Requirements and Related Matters of First Imported Non-Special Cosmetics for Pudong Pilot Filing Management”. |
5. Applicants whose application of registration for first imported non-specials cosmetics has been accepted by NMPA before Nov. 10, 2018 are permitted to withdraw it by Nov. 20. Otherwise, the application will undergo technical review following the previous registration procedure and requirements.
Applicants who haven’t obtained registration approval before Nov. 10 are permitted to file as required by this Announcement, excluding products rejected for safety reasons. |
6. Pursuant to the previous registration requirements, stakeholders with an obtained approval certification can continue to import product within its validity period. Reissue and correction of registration certifications during the period is also permitted.
But for renewal or change of the registration certification, it is required to apply for filing in line with the requirements of this announcement. |
ChemLinked Interpretation:
Simply put, there are 4 situations for companies who have applied for registration to NMPA to adjust their business based on the announcement, as shown in the below diagram.
Directly choose filing through online system from Nov. 10.
In cases where the registration application has been accepted by NMPA before Nov. 10, enterprises can either obtain paper registration approval after technical review or withdraw the application before Nov.20 and apply for filing with the authorization of RP. For a product under technical review and needed to supplement non-safety-related dossiers, the required dossiers shall be submitted to NMPA.
The approved registration certification is only effect for importing the product. Filing is mandatory for any changes or renewal of the certification.
Comparison of different regulatory system
Comparison of the new filing system and previous registration of first-imported non-specials cosmetics as well as filing of domestic cosmetics | |||
| Registration | Filing after Nov.11 (essentially the same as Pudong filing) | Filing of domestic cosmetics |
Subjects | First-imported non-special use cosmetics | First-imported non-special use cosmetics | Domestic non-special use cosmetics |
Applicant | Responsible agent | Responsible person | Cosmetic manufacturer |
Guidance document | Guidelines for Registration Review and Approval of Imported Non-special Use Cosmetic Products | Currently can refer to previous CFDA’s notice: Procedures of Filing Management for First Import Non-special Use Cosmetics through Shanghai Pudong New Area (Interim) | Requirements for Filing of Domestic Non-special Use Cosmetic Products |
Animal testing | Mandatory requirements | Mandatory requirements | Not mandatory, safety assessment is applicable |
Documents receiving window | NMPA |
| Provincial administration for market regulatory (previous provincial FDA) |
Review | Review paper documents | Online review | Online review |
Procedures |
|
|
|
Certificate | Paper registration certificate | Electronic filing certificate | No certificate |
Post-market supervision | No requirements | Within 3 months after the approval | Within 3 months after the approval |
Tips for stakeholders
All first-imported non-special use cosmetics are subject to filing system; special use cosmetics and new ingredients are still subject to registration management.
Animal testing is still necessarily required for filing system.
NMPA is no longer capable of registration of first imported non-specials cosmetics and three affairs will be definitely rejected, i.e. new registration application, renewal and change of certification.
Enterprises who have registered with NMPA shall entrust a reliable domestic responsible person as soon as possible. For strong companies, establish branches in China as RP is the safest way to conduct business.
Responsible person whose registration place lies in the above-mentioned 11 FTZs, it is required to submit paper documents to the provincial authorities while responsible person whose registration place outside the 11 FTZs still requires to submit paper dossiers to NMPA after finishing online dossiers submission.
If the product has finished testing for administration license by responsible agent, the testing report still applies to filing but a description of the situation together with RA’s informed consent shall be submitted.
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