《上市中成药说明书安全信息项目修订技术规范》系列团体标准解读

由北京中医药大学中药药物警戒与合理用药研究中心牵头,中华中医药学会归口管理的《上市中成药说明书安全信息项目修订技术规范》系列团体标准于2021年7月23日正式发布,7月31日起实施.该系列团体标准包括6项,分别是《通则》《不良反应》《禁忌》《注意事项》《特殊人群用药》《警示语》.其中《通则》为纲领性技术规范,阐释中成药...

Interpretation of Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions

Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions,a series of group standards,were proposed by Professor ZHANG Bing from Research Center for Pharmacovigilance and Rational Use of Traditional Chinese Medicine,and underwent centralized management by Chinese Association of Chinese Medicine.They were officially released on July 23 and implemented on July 31,2021.The series of group standards consist of six sections,including general principles,adverse drug events,contraindications,precautions,application for special populations,and warnings.The section of general principles is comprised of holistic and programmatic expressions,which explain the general technical requirements for revising the marketed Chinese patent medicine instructions.The other five sections focus on information collection,screening,transformation,and illustration of specific items,forming a standardized revision technical process.This series of standards is the result of multiple rounds of research and the suggestions of more than 200 experts in different professional fields of"medicine-pharmacy-management-law-enterprise"have been gathered therein to reach a consensus.With the purposes of establishing standardized technical specifications for the revision of safety information in the marketed Chinese patent medicine instructions,guiding marketing authorization holders in revising the instructions,filling the gaps in the research of Chinese patent medicine instructions,promoting the deve-lopment of pharmaceutical care and academic research,and encouraging the rational and safe medication of Chinese patent medicine,the series of group standards is of great significance.