To promote the construction and sharing of cosmetics supervision data, China National Medical Products Administration (NMPA) has formulated standards for related basic data sets.
On Sep. 24, 2021, NMPA released the following five standards for public consultation:
Basic data set of cosmetics production license management
This data set mainly includes the basic data set required for the informatization construction of cosmetics production license management, including the data related to cosmetics production license application, processing, and approval.
Basic data set of ordinary cosmetics products record-keeping system management
This data set mainly includes the basic data set required for the informatization construction of ordinary cosmetics record-keeping management.
Basic data set of special cosmetics registration system management
This data set mainly includes the basic data set required for the informatization construction of special cosmetics registration management.
Basic data element of cosmetic administration information (Registration and production license)
This standard specifies the information data elements in the drug regulatory information, including identifier, Chinese name, short name, definition, data type (of the data element value), format, allowable value, unit of measurement, version and source of cosmetics registration, record-keeping, and production license.
Coding for value domain of cosmetic administration information basic data element (registration and production license)
This standard specifies the data element value domain codes of cosmetic-related information in drug regulatory information.
Public consultation of the five standards will end on Oct. 23, 2021. Any suggestions can be mailed to NMPA (firstname.lastname@example.org) before the deadline.
The promulgation of the standards marks a new stage of digitalization and informatization in China’s cosmetic supervision and management. The standardized data is expected to become the basis for cosmetics’ traceability during the industry supervision.
Standardizing the basic data set of cosmetics production license, notification and registration is conducive to unifying the management standards of cosmetics' pre-market approval, production and operation. This improvement can also make up for the limitations of manual review on pre-market application dossiers to a certain extent.
In the future, data sharing may not be limited to the regulatory authorities but also extend to the public and e-commerce operating platforms. Thus, multiple parties can work together to supervise cosmetics companies and crack down on violations of laws and regulations.