Updated Guidance on Importing “Non-Special Use Cosmetics” Through Pudong, Shanghai

Takehome:

Shanghai FDA hosted an internal meeting releasing new information on filing management procedures and requirements for import of "non-special use cosmetics" through Pudong, Shanghai.

During the meeting the following information was released which was not detailed in the previously released official guidance:

1. Compared with current cosmetic product registration procedures, filing management places a greater emphasis on technical review and post-market surveillance;
2. The responsibilities of the "responsible person" have been clarified;
3. All information relating to products will be posted online affording greater information transparency;
4. Clarification of the qualifying criteria and requirements for filing management and registration have been offered.

Reinforce technical review and post-market surveillance:

Filing management is designed to simplify pre-market procedures and facilitate market access, while still ensuring product safety and quality. To this end technical review and post-market surveillance will be strengthened.

Current registration procedures emphasize pre-market approval, while supervision on products circulating in the market is relatively lacking. Measures such as sample inspection, adverse effect supervision and traceability have not been comprehensively integrated into the supply chain. Punishment for illegal advertisements, product adulteration, fake finished products and use of exaggerated, false or misleading promotion and/or labeling claims are still relatively lax.

Regarding filing management, the meeting detailed the exact methods that will be used to strengthen technical review and post-market surveillance, in order to guarantee product safety and quality. Technical review is executed by Shanghai FDA. Product formula, production techniques, inspection items and safety assessment documentation will all be reviewed in a more stringent way.

Post-market surveillance will be conducted by FDA and include:

1. Check if information on label and claim is in accordance with that on file
2. Check if filed record (generated automatically online) of imported products is marked on Chinese label;
3. Check if traceability system is used
4. Check if company perform inspection on their stock;
5. Investigate adverse reaction;
6. Conduct market sample inspection;
7. Accept complaint and report;
8. Conduct public monitoring;
9. Cooperate and exchange information with Dept. of CIQ and Customs;
10. Fine certain violations
11. Realize public information dissemination using internet

Expand responsibilities of local responsible person:

 Another difference between the Shanghai Pudong filing management system and the current national registration system is the role of the responsible person and associated duties. During the meeting, a Shanghai FDA speaker also specified detailed responsibilities for the "local responsible person", including requirements  to

1. Establish a quality and safety control system, to hire legal personnel and establish a quality control department;
2. Fulfill traceability of products (especially first import cosmetics);
3. Check if all information (label on package, claim and preservation condition) is in accordance with that on the filing record;
4. Take immediate action to publish information and recall all products when quality and safety problems occur;
5. In the early stages of the new filing management system the responsible person will have to bring both the filing certificate and the dossier receipt to Shanghai CIQ before marketing. This procedure will be simplified when information sharing is realized by FDA and CIQ;
6. A third party "import and export cosmetic expert committee" will be established to provide advice, draft guidance for quality and safety control management, and organize workshop, etc.

Comparison with previous "responsible agent":

Disclose filing information

For filing management, all the information relating to products, including submitted documents, post-market surveillance results etc. will be posted online. The FDA hopes to realize transparency so that they may enhance public supervision. Once problems or violations are uncovered the company will face CFDA punishment and public backlash.

Clarify the filing requirements for different products

Because registration will also exist in other ports, oversea companies must have a full understanding of the basic filing requirements for different products:

1. One product cannot apply for both registration and filing at the same time.
2. Products with a registration certificate can also import from Shanghai Pudong new area;
3. If products with a filing record want to import from other ports (except for shanghai Pudong), they need to cancel the filing record and apply for registration;
4. If products fail registration, they are not allowed to apply for filing management.

REACH24H Interpretation:

Companies may choose to file a record with Shanghai FDA to save time on pre-market procedures, because products which undergo registration need a long term to get approval from CFDA. Filing management doesn't mean reduced requirements; on the contrary, filing management will strengthen technical review and post-market surveillance. Once problems are found, importers will be required to stop importation and sale, issue a product recall and will be subject to fines. All information related to filing will be available to the public including all safety and quality violations which could seriously damage an enterprises reputation and future prospects in China.