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Take home:
The implementation of filing management for import of non-special cosmetics through Pudong, Shanghai has been in practice for several days. Cosmetic enterprises like L'Oréal are already using the new system. Practical implementation has revealed some problems. In this Q&A, regulatory compliance experts from REACH24H answer questions relating to issues which include: the "differences between registration and filing management", clarifications on "local responsible person", "preparation before application" and "post-market surveillance", etc.
Differences between registration and filing management
1.In order to expedite China market access for imported cosmetics can filing management be undertaken prior to full registration?
A: It is possible, but one product can only obtain one kind of certificate. That means if the applicant applies for registration later, the filing certificate should be cancelled. It's necessary to remember that filing management is not an approach to avoid regulatory requirements. Although it is quicker to import and sell products using filing management, there are still strict technical requirements and a full product review within 3 months after market entry. If any problems are found, the product will be stopped from further import until the applicant submits supplementary documents. If any illegal actions are found, all information will be published online. Problems found during filing management will also directly impede subsequent registration efforts. It is still unclear if the filing certificate can be canceled within 3 months of technical review.
2. Can we apply for filing management while simultaneously undertaking cosmetic registration? Can we use data generated under a registration application for filing management and vice versa? Should the responsible person be made aware of a change from a filing application to a registration application?
A: Currently there is no clear answer to this complex question. It would make sense that some data generated for one application would be acceptable for another application however we can still expect changes and refinements to the filing management system. It would be prudent for all applicants to make their designated responsible person aware of all changes to applications etc.
Clarifying local responsible person/agent
1. What are the key differences between "responsible person" and "responsible agent"?
A: Both of them are under the authority of the CDFA.
"Responsible agent" is tasked with obtaining a registration certificate for imported cosmetics and only one "responsible agent" can be entrusted by one overseas cosmetic enterprise in one period;
"Responsible person" is a termed used exclusively in association with the new Shanghai, Pudong filing management system for import of non-special use cosmetics. Overseas enterprise can authorize only one "responsible person" to be in charge of one product in a given time period. That means overseas enterprise can entrust more than one "responsible person" provided they have more than product.
A clear comparison between "responsible agent" and "responsible person" has been outlined in CL new s, here: CL.
2. Does a "responsible person" need to have specific qualifications?
A: FDA and CIQ have told us that there are no special requirements are for "responsible person" at the moment. The "responsible person" should be an independent enterprise or legal person, and will shoulder the responsibilities of importing, handling and ensuring the quality and safety of cosmetics. The "responsible person" has to handle all cosmetics within the official business operation scope and in compliance with relevant commercial and industrial regulations.
3. Can "responsible person" be changed?
A: Yes, as long the specific procedures relating to information modification are followed. To avoid civil disputes it is wise to inform the previous "responsible person".
Preparation for application of filing management
1. Does a sealed sample need to be submitted?
A: No, a sealed sample can be maintained within the enterprise for future reference.
2. How will dossiers be checked?
A: Shanghai FDA will check the following: a) if products fall within the scope of filing management, b) if dossiers are complete, and c) if dossiers are in accordance with requirements.
3. Will it be possible to successively file a record on the same day as dossiers are submitted in hard copy?
A: Yes, as long as all dossiers are checked on time. Appointment for submission of hard copies must be made after submitting dossiers online.
4. Will Shanghai FDA issue the certificate on the spot when successfully filing a record?
A: After filing a record, Shanghai FDA will issue a receipt. The formal filing certificate should be printed from the online system by the "responsible person". Enterprise should bring both the certificate and the receipt to CIQ relevant office.
5. Will all information be published on line?
A: Yes, as clarified in CL News: CL.
6. What if a modification to a product imported via the filing management system is made?
A: Modification of information can be made as long as applicants follow the modification procedures which are released in “Procedures of Filing Management for First Import Non-special Us Cosmetics through Shanghai Pudong New Area (Interim)”. For example, if your marketed product package is different from the ones that have been filed, you need to apply for modification.
About post-market surveillance
1. Will every product be inspected on the spot? Will applicants be informed before inspection?
A: Spot inspection is not mandatory. If necessary, enterprises will be informed of inspections in advance.
2. Who will conduct technical review? CFDA or Shanghai FDA?
A: The technical review should be conducted by Pharmacy Department of Shanghai FDA
3. After the trial period of the Pudong filing management system has elapsed, will filing certificates still be valid?
A: If successful in Shanghai, filing management is likely to be rolled out on a national level. Based on this scenario filing certificates are likely to remain valid. see CL.
REACH24H Interpretation:
Filing management certainly reduces pre-market review time. Its highly likely that numerous cosmetic enterprises will choose to import cosmetics through Pudong in order expedite market entry. It is also highly likely that a successful trial of filing management in Pudong will see the new initiative rolled out on a national level.
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