In July 2023,the National Medical Products Administration issued the Measures for the Administration of Standards for Medicinal Products(hereinafter referred to as the Measures).This article interprets the main content of the Measures,and analyzes its shortcomings as unclear definition of the drug standard code and the goals of drug standard information construction.It is recommended that the national drug regulatory department promptly apply to the standardization authority for the confirmation of the drug standard code"YB"letter,and the drug standard code and numbering rules would be included in the next round of amendments to the Measures.It is necessary to clarify the construction goals of the information system for drug standards at the same time,and build a national drug standard data-sharing platform based on the basic framework of user interface layer,computing processing layer,and data storage layer.Digital drug standards will be free,and access and download services for the public will be provided.
关键词
药品标准管理办法/药品标准代号/药品注册标准/信息化/解读
Key words
Measures for the Administration of Standards for Medicinal Products/drug standard code/drug registration standards/informatization/interpret
维普
万方数据