电子药品说明书适老化管理系统

为优化药品说明书管理，满足老年人、残疾人用药需求，解决药品说明书“看不清”问题，根据《中华人民共和国药品管理法》《中华人民共和国无障碍环境建设法》，国家药监局决定在部分口服、外用等药品制剂中开展药品说明书适老化及无障碍改革试点。
持有人可以在药品最小销售单元包装或者纸质药品说明书上印制条形码或者二维码，通过扫码可以获得电子药品说明书（完整版）。电子药品说明书（完整版）格式应当符合《电子药品说明书（完整版）格式要求》，内容应当准确并与药品监管部门核准的最新版本药品说明书一致。

To optimize the management of pharmaceutical package inserts, meet the medication needs of the elderly and persons with disabilities, and address the issue of poor legibility of package inserts, pursuant to the Drug Administration Law of the People's Republic of China and the Law on the Development of Accessible Environment of the People's Republic of China, the National Medical Products Administration (NMPA) has decided to launch a pilot reform on making package inserts age-friendly and accessible for some oral, topical and other pharmaceutical preparations. Marketing Authorization Holders (MAHs) may print barcodes or QR codes on either the packaging of the drug's smallest sales unit or the paper package inserts. The full-version electronic package insert can be obtained by scanning the printed code. The format of such full-version electronic package inserts must comply with the "Format Requirements for Full-version Electronic Package Inserts", and their content shall be accurate and consistent with the latest version of the package insert approved by the drug regulatory authority.

搜集汇总

背景与挑战

背景概述

该数据集涉及药品电子说明书适老化改革，旨在通过二维码技术为老年群体提供可读性更强的电子版药品说明书，其格式和内容需符合国家药监局制定的规范要求。