11.15.18
The China National Medical Products Administration reported that as of Nov. 9, the registration of first-imported non-specials cosmetics will be entirely replaced by filing management nationwide from Nov. 10, 2018. Under this new regulatory scheme, foreign manufacturers shall designate a domestic responsible person (RP) and authorize this person 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.
According to ICMAD, “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 must complete filing to provincial administration for market regulation only after online filing application and dossiers submission. Domestic responsible person located outside pilot zones in China shall complete filing to NMPA only after online dossiers submission. Currently, the filing certification has no limit of validity provided the authorization of RP is valid, in comparison to a registration certificate, with a 4-year term.
Manufacturers of imported cosmetics are responsible for authorization of the domestic responsible person, user registration of online system, submission of filing dossiers, in accordance with the previous CFDA's notice Procedures of Filing Management for First Import non-special Use Cosmetics through Shanghai Pudong New Area for the time being.
Regarding the inspection report of the first imported non-special use cosmetics, overseas enterprises must comply with the requirements under "Notice of Inspection Report Requirements and Related Matters of First Imported Non-Special Cosmetics for Pudong Pilot Filing Management".
ICMAD says as of this notice, the data requirements for filing are the same as for registration, which includes animal testing.
According to ICMAD, “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 must complete filing to provincial administration for market regulation only after online filing application and dossiers submission. Domestic responsible person located outside pilot zones in China shall complete filing to NMPA only after online dossiers submission. Currently, the filing certification has no limit of validity provided the authorization of RP is valid, in comparison to a registration certificate, with a 4-year term.
Manufacturers of imported cosmetics are responsible for authorization of the domestic responsible person, user registration of online system, submission of filing dossiers, in accordance with the previous CFDA's notice Procedures of Filing Management for First Import non-special Use Cosmetics through Shanghai Pudong New Area for the time being.
Regarding the inspection report of the first imported non-special use cosmetics, overseas enterprises must comply with the requirements under "Notice of Inspection Report Requirements and Related Matters of First Imported Non-Special Cosmetics for Pudong Pilot Filing Management".
ICMAD says as of this notice, the data requirements for filing are the same as for registration, which includes animal testing.