Annual Report System to Be Implemented For First-Imported Non-Special Use Cosmetics Filing Management

Takehome:

• It is possible that mandatory annual reporting will be implemented for first-imported non-special use cosmetics filing management.

• Registration of first imported cosmetics to NMPA will be entirely replaced by filing to the provincial MPA from Nov. 30 in Guangdong.

1. Latest news

On Nov 30, 2018, Guangdong Medical Products Administration (Guangdong MPA) released its provincial enforcement rules along with a detailed filing service guidance, stipulating post-reform filing requirements for imported non-special use cosmetics.

Responsible person registered in Guangdong free trade zone Nansha area, Huangpu area, Hengqin new area and Qianhai Shekou area shall complete filing to competent authority in these 4 areas. RP registered outside the above 4 areas in Guangdong shall complete filing to Guangdong MPA. Information of the acceptance offices are:

• Huangpu area

Address: Area B, 3rd floor, No.3 Xiangxue 3rd Road, Huangpu District, Guangzhou City
Phone number: 020-82118627, 82112387

• Nansha area

Address: Nansha Government Service Center, No.1 Fenghuang Avenue, Nansha District, Guangzhou City
Phone number: 020-39053020

• Qianhai Shekou area

Address: Government Service Center, Comprehensive Office Building A, Qianhai Shenzhen-Hong Kong Cooperation Zone, No.1 Qianwan First Road, Nanshan District, Shenzhen City
Phone number: 0755-88988988

• Hengqin new area

Address: Comprehensive Service Center, Building 1, No.189 Baoxing Road, Hengqin New Area, Zhuhai City
Phone number: 0756-2990168

• Other areas in Guangdong

Address: First floor, No.753 East of Dongfeng Road, Yuexiu district, Guangzhou city
Phone number: 020-37886014

2. Annual report system

According to current regulations, there is no expiry date for an imported or domestic non-special use cosmetics filing certificate. This does not mean that once a product is filed its filing certificate will remain valid indefinitely. NMPA is drafting Administrative Measures on Filing for Non-Special Use Cosmetics, which will include:

• Responsibilities of RP

• How to re-file expired products

• The requirements for consignee

• How to apply for filing information changes, etc.

The potential of using an annual reporting system to manage non-special use cosmetics filing is being considered by Chinese authorities. Under the system enterprises will be required to regularly report the production and import of cosmetics, market sales and adverse reactions monitoring condition through the online filing platform. Filing approval and by extension market access of products that fail to fulfill annual report obligations will be rescinded. The draft is expected to be released in Dec 2018.

3. Post-market technical review focuses on product safety

Chinese Herbology Protection Review Committee temporarily undertakes the technical review of the first imported non-special use cosmetics filing documents outside the 11 pilot provinces. The technical review of the filing documents focuses on whether product formulation, manufacturing technique, inspection items and safety assessments meet safety requirements. The core concern is product formulation.

The basis of product formulation review is IECIC, INCI, and Safety and Technical Standards for Cosmetics 2015. The main focus of the review is the standardization of ingredient names, documents format specification, whether the ingredients are permitted, whether the use of ingredients is within the limitation, etc.

Note: Products that have claims specific to pregnant women, lactating women, children or infants shall also provide documents of product formulation design principles based on safety considerations (including overall analysis report of product formulations), selection criteria and requirements for ingredients, manufacturing technique, quality and safety control.

4. Cross-regional supervision

Domestic responsible persons intending to import a filed product from other ports outside the registered area are required to supplement relevant information about the new import port and the consignee through the online filing system. The Medical Products Administration where the consignee is located will undertake responsibility for post-market surveillance and conduct an additional technical review on filing documents.

For example, if the RP completes filing in Guangdong but imports the products through ports in Zhejiang, in this instance Zhejiang MPA shall undertake post-market surveillance of these products, and conduct an additional technical review of filing documents.

The following table shows the similarities and differences between RP and consignee.

5. Problems may occur

In response to the problem of inconsistency in the review of filing documents and supervision of products, NMPA has conducted training for the experts reviewing filing documents during the policy pilot period. There are at least five experts in each pilot province which have already passed the assessment organized by NMPA.

Stakeholders with any other questions about imported non-special use cosmetics filing management can refer to CL news. Also ChemLinked held a webinar detailing the filing requirements on Dec 10, 2018.