Chapter 7 Guideline for Drug Information Services Evaluation
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.
drug package insertlabelingdrug technical review reportpharmaceutical risk management plan
NETL
NSTL
万方数据
