On December 30, 2022, the National Medical Products Administration issued a notice on the publishing 5 informatization standards for the cosmetic industry. The five standards will come into force as of the issuing date.

These five standards were drafted with the support of the China National Institute of Standardization (CNIS) per current laws and regulations which include but are limited to the Cosmetics Supervision and Administration Regulations (CSAR), Administrative Measures of Registration and Filing of Cosmetics and Measures for Supervision and Administration of Cosmetic Production and Operation.

The main contents of the standards are summarized as follows:

·   NMPAB/T 03015.1-2022 Basic data element of cosmetic administration information Part 1: Production license and registration or filing and NMPAB/T 03035.1-2022 Coding for value domain of cosmetic administration information basic data element Part 1: Production license and registration or filing

These two documents specify the data element source and coding for value domain of cosmetic registration and filing and manufacturing license information, including but not limited in identifier, Chinese name, short name, definition, data type (of data element value), presentation format, allowed value, a unit of measurement, version and source. It covers all relevant data elements used in cosmetics production license, product record, product license management business related application/acceptance, on-site inspection, approval and other information. 

·   NMPAB/T 0307.1-2022 Basic data set for cosmetic production license management, NMPAB/T 0307.2-2022 Basic data set for general cosmetic production filing management, and NMPAB/T 0307.3-2022 Basic data set for special cosmetic registration management

The scope of these three standards covers relevant contents for the basic data set used for the registration process of production, general and special cosmetics products. Details range from the category and data item description to data subset etc., which would be mainly sued for the database construction for such products. Specification and requirements on basic, application, reviewing and management data subset for the registration of relevant contents are also elaborated.  

All standards are specified requirements in regard to the medicine/cosmetic supervision system. They are also supportive documents that fill in the blank on the informatization requirements of cosmetics. Foreign stakeholders are advised to have their compliance team dig into the details and take necessary actions. 

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