《药品标准管理办法》解读与思考

Interpretation and reflection on the Measures for the Administration of Standards for Medicinal Products

2023年7月,国家药品监督管理局发布《药品标准管理办法》(以下简称《办法》)。本文就《办法》的主要内容进行解读,分析其存在的不足为:《办法》现有条文中对药品标准代号和药品标准信息化建设目标未明确。建议国家药品监督管理部门及时向标准化主管部门申请药品标准代号“YB”字母的确权,并将药品标准代号、编号规则在下一轮《办法》修正时写入条文,同时明确药品标准信息化体系建设目标;按用户界面层、计算处理层、数据存储层的基本框架搭建国家药品标准数据共享平台,免费向社会公开数字化药品标准,提供查阅和下载服务。

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.