CIRS Interpretation of the Measures for the Administration of Cosmetics Registration and Filing Draft for Comments Cosmetics New Raw Materials

Chapter  1: General Provisions (Article 1 to 7)

Contents: basis of formulation, scope of  application, definition, classification management, authority of national  bureau, authority of provincial bureau, information disclosure

Main Contents:

1） The definition of  registration and filing

• Registration: The registration applicant shall apply for  registration in accordance with legal conditions, procedures and  requirements, and the drug regulatory department shall examine the safety and  quality control of the cosmetics or new cosmetics raw materials applied for  registration and decide whether to approve the activities of the registration  application.

• Filing: The filer shall carry out the activities of filing for  official examination via submitting to the drug regulatory department the  materials indicating the safety and quality control of the products in terms  of the statutory conditions, procedures and requirements.

2）Define the product  scope of classification management

• Registration management: special cosmetics and new raw materials  with higher safety risks of the functions for anti-corrosion, sunscreen,  coloring, hair dying, anti-freckle and whitening.

• Filing management: general cosmetics and other new materials

3）Define the  responsibilities of each department of the competent authority

• National Medical Products Administration (NMPA): to be in charge  of the registration and filing administration of cosmetics and new raw  materials nationwide; to be responsible for the registration and filing  administration of special cosmetics, imported ordinary cosmetics and new raw  materials.

• The cosmetic technical review department of NMPA (hereinafter  referred to as the technical review department): be responsible for the  technical review of the registration of special cosmetics and new raw materials,  and bear the responsibility of the review work after the filing of imported  ordinary cosmetics and new raw materials.

• The acceptance service department of administrative matters of  NMPA (hereinafter referred to as the acceptance department): accept the  registration required for the cosmetics registration and filing  administration according to its functions.

• The examination and verification department of administrative  matters of NMPA: undertake the on-site verification required for the  cosmetics registration and filing administration according to the functions.

• The adverse reaction monitoring department of the administrative  matters of NMPA: undertake the adverse reaction monitoring required for the  cosmetics registration and filing management according to its functions.

• The information management department of administrative matters of  NMPA: undertake the certification delivery, information publicity and  corresponding information construction and management for the cosmetics  registration and filing management according to its functions.

• The medical products supervision and administration departments of  provinces, autonomous regions and municipalities directly under the Central  Government: be responsible for the filing management of domestic ordinary  cosmetics within their respective administrative regions, and participate in  on-site verification related to the registration of special cosmetics. The medical  products supervision and administration departments of provinces, autonomous  regions and municipalities directly under the Central Government with  corresponding ability are entrusted by the National Medical Products  Administration to undertake the filing management of imported ordinary  cosmetics.

Chapte r  2: Basic Requirements (Article 8 to 13)

Contents: the definition and  responsibilities of registrants and filers, the requirements of cosmetic  registrants and filers and the obligations of domestic responsible persons  are clarified. An expert consultation mechanism has also been added.

• Registrants and filers: refers to an enterprise or other  organization that places products to the market in its own name and can  independently bear civil liability.

• Responsibilities of registrants and filers: assume the main  responsibility for product quality and safety, fulfill the obligations of  product registration and filing according to law, and be responsible for the  quality, safety and efficacy claim of its products.

• When an overseas enterprise acts as a registrant or filer, an  enterprise legal person within the territory of China shall be designated as  the domestic responsible person. Its obligations include:：

(1) Register and  file new cosmetic raw materials in the name of the registrant and filer, and place  the products on the domestic market;

(2) Assist the  registrant and filer in the monitoring of safety and reporting of new  cosmetic raw materials;

(3) Cooperate  with the supervision and inspection work of the supervision departments.

• Expert consultation mechanism: the medical products supervision  and administration department, the technical review  department and other technical institutions responsible for the management of  registration and filing shall establish an expert consultation mechanism for  registration or filing, and listen to expert opinions on important issues in  the process of technical review, supervision and inspection.