CHINESE JOURNAL OF DRUG EVALUATION >

2025 , Vol. 42 >Issue 5: 325 - 325-331

DOI: https://doi.org/magtech-2025-07-22-00001

Research on the Construction and Practice of Electronic Drug Package Insert Age-friendly Management System Under the Perspective of Intelligent Regulation

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  • Jiangxi Medical Products Administration， Jiangxi Nanchang 330000， China

Received date: 2025-07-22

  Revised date: 2025-09-26

  Accepted date: 2025-11-27

  Online published: 2025-12-15

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Abstract

With the accelerating aging process of China′s population， medication safety issues among the elderly have become increasingly prominent. Traditional drug package inserts with small fonts and complex medical terminology create widespread difficulties for elderly patients who “cannot see clearly and cannot understand” the information. In response to the national pilot policy for age-friendly and barrier-free reform of drug package inserts， Jiangxi Medical Products Administration took the lead in exploring the construction of an intelligent management system for electronic age-friendly drug package inserts. Based on the pilot practice in Jiangxi Province， this study systematically expounds the design concept， technical architecture， and core functions of the management system. The system adopts a “four-layer， three-terminal， one-cloud” architecture， integrating enterprise-side filing management， regulatory-side intelligent review， and user-side convenient service functions. It employs advanced technologies such as OCR recognition， AI voice synthesis， and the DeepSeek-R1 large model to achieve intelligent verification of insert content， voice broadcasting， and barrier-free inquiry services. The pilot operation results show that 132 varieties from 29 marketing authorization holders participated in the reform， with the system generating 294 electronic drug insert QR codes， effectively addressing barriers for elderly people in accessing medication information. The study summarizes and refines a replicable model of “policy guidance+technical support+collaborative division of labor”， validating the application value of digital means in pharmaceutical regulatory reform and providing practical examples and technical pathways for the nationwide promotion of age-friendly drug package insert reform.

Key words： ; font-size:medium; ">Drug package inserts； Age-friendly reform； Intelligent regulation； Barrier-free services

Cite this article

XIONG Haiyan, XU Renen, RAO Long . Research on the Construction and Practice of Electronic Drug Package Insert Age-friendly Management System Under the Perspective of Intelligent Regulation[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2025 , 42(5) : 325 -325-331 . DOI: magtech-2025-07-22-00001

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