第七章 药品信息服务评价指南
Chapter 7 Guideline for Drug Information Services Evaluation
官海静 1赵志刚1
作者信息
- 1. 首都医科大学附属北京天坛医院 药学部,北京 100070
- 折叠
摘要
药品信息服务是药品综合评价的重要信息来源和主要评价内容之一,包括法定药品信息与其他关键信息.法定药品信息主要是指药品说明书与标签,其他关键信息主要是指药品技术审评报告、上市药品风险管理计划、药品注册分类、药品专利信息、药品宣传或推广资料等.本章基于药品综合评价的研究需求,通过检索和梳理国家相关政策文件,系统阐述了药品说明书、标签、药品技术审评报告等关键信息的评价内容与标准,旨在为药品信息服务评价提供参考.
Abstract
Drug information is a crucial source of comprehensive drug evaluation and constitutes a primary aspect of such evaluation.Drug information encompasses both legally mandated drug information and other key data.Legally mandated drug information primarily includes the drug's package insert and labeling,while other key data refer to documents such as the drug's technical review report and the risk management plan for marketed drugs.This chapter,grounded in the research needs of comprehensive drug evaluation,systematically elaborates on the evaluation content and standards for essential information,such as drug package inserts,labeling,and technical review reports,by analyzing relevant national policy documents.The aim is to provide a reference for the evaluation of drug information.
关键词
药品说明书/标签/药品技术审评报告/药品风险管理计划Key words
drug package insert/labeling/drug technical review report/pharmaceutical risk management plan引用本文复制引用
出版年
2024
NETL
NSTL
万方数据