Under this new regulatory scheme, foreign manufacturers must elect a domestic responsible person (RP) and authorise the individual to file a record via the 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 for import and distribution.
Domestic Responsible Person
According to Winnie Xu of Chemlinked, the RP’s registration place must be one of the 11 Free-Trade Zones, which include Tianjin, Liaoning, Shanghai, Zhejiang, Fujian, Henan, Hubei, Guangdong, Chongqing, Sichuan and Shanxi.
“The RP will have to complete filing to provincial administration for market regulatory, which was previously the provincial FDA, after online filing application and dossiers submission,” she said.
For RPs located outside the pilot zones in China, Xu said they will need to complete filing to NMPA after an online dossiers submission.
If the RP intends to import a filed product from more ports outside of the designated location, they are required “to supplement relevant information about the new import port and the consignee through online filing system.”
Regardless, added Xu, will still be animal-testing required for filing.
New rules
“In practical implementation, the operation of the updated filing system is essentially the same as the previous filing system,” said Xu.
She further clarified that there will be no restriction of import port and cosmetics are allowed to be imported from different ports rather than being confined to RP’s registration port.
“This means the electronic filing certification will have the same force as the paper registration certificate,” Xu added.
Currently, the filing certification has no limit of validity while the registration certificate has a four-year validity, provided the authorisation of RP is valid, said Xu.
In accordance with the previous CFDA's notice: Procedures of Filing Management for First Import non-special Use Cosmetics through Shanghai Pudong New Area, manufacturers of imported cosmetics will be responsible for authorisation of the RP, user registration of online system, submission of filing dossiers, among others.
In regards to the inspection report of the first imported non-special use cosmetics, overseas enterprises need to observe the requirements under the Notice of Inspection Report Requirements and Related Matters of First Imported Non-Special Cosmetics for Pudong Pilot Filing Management.
Previously accepted applications
Companies that have applications that have been accepted by NMPA before Nov 10 were allowed to withdraw by Nov 20. Otherwise, said Xu, the application will have to undergo technical reviews, which will follow the previous registration procedure and requirements.
As for application that have not obtained an approval by the Nov 10 deadline, the new regulations will require applicants to refile accordingly. However, products which have been rejected for safety reasons are not advised to file again.
Similarly, she said, products seeking renewal or change of registration certificate will be required to apply for filing in line with the new requirements.
