《上市中成药说明书安全信息项目修订技术规范》系列团体标准

药品说明书是载明药品重要信息的法定文件,是表达药物有效性与安全性的重要技术资料.其作为指导医生、药师和患者合理用药的重要依据,科学、规范、准确的表述直接关系到公众的用药安全.药品说明书安全信息项目是指能够直接反映药品的安全性与合理用药措施的相关项目,包括不良反应]、禁忌]、注意事项]、特殊人群用药以及警示语.在产...

Series of group standards of Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions

Drug instructions,the statutory and technical documents recording effectiveness and safety information,are an important basis for guiding doctors,pharmacists,and patients to use drugs rationally,and their scientificity,standardization,and accuracy directly affect the medication safety of the public.The sections of adverse drug events,contraindications,precautions,warnings,and application for specific populations in drug instructions directly express safety information and measures for rational use of drugs.In the drug life cycle,marketing authorization holders(MAHs)need to update safety information in the instructions promptly to ensure the safety and effectiveness of clinical drug medication.At present,revising instructions is an important measure to control drug risks.In the drug life cycle,in order to standardize the revision of safety information in the instructions by MAHs and eliminate inexact terms such as"unclear",the Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions,a series of group standards,have been established under the guidance of Standardization Department,China Association of Chinese Medicine.Therefore,on the basis of the existing rules and regulations,the standardized technical procedures for revising instructions came into being to help clinical safe and rational medication of drugs,and implement the strategy of"Healthy China".