我国药品质量公告工作要点分析及实施建议  

Analysis of key points and suggestions for implementation on drug quality disclosure in China

作　　者：刘文[1] 王翀[1] 朱炯[1] 胡增峣 LIU Wen;WANG Chong;ZHU Jiong;HU Zengyao(National Institutes for Food and Drug Control,Beijing 102629,China;National Medical Products Administration,Beijing 100037,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]国家药品监督管理局,北京100037

出　　处：《药物评价研究》2021年第12期2539-2544,共6页Drug Evaluation Research

摘　　要：我国药品质量公告制度具有充分上位法依据和严厉的制裁性,在实践中应充分保障被公告单位的知情权和复验权、申诉权以及公众对药品质量的知情权。为此,药品质量公告应重点关注不合格报告书的签收、药品生产企业的确认、被公告单位的复验和申诉以及公告的及时性和完整性。为更好发挥药品质量公告的作用,建议有关部门在重点落实上述要点的基础上进一步建立并执行标准操作规程,杜绝侥幸心理,重视上游管理、舆情监测和大数据利用。Drug quality disclosure had sufficient upper-level legal basis and strict sanctions, and should fully protect the rights to know, re-test and appeals of the disclosed units, as well as the public’s right to know the quality of drugs. To this end, the drug quality disclosure should focus on the signing of the report of substandard drugs, the confirmation of the drug manufacturer, the retest and appeal of the disclosed units, and the its timeliness and completeness. In order to better play the role of the drug quality disclosure, it is suggested that the relevant departments further establish and implement SOPs, reject fluke psychology, and attach importance to upstream management, public opinion monitoring and the use of big data on the basis of focusing on the implementation of the above key points.

关 键 词：药品质量公告 国家药品抽检 知情权 舆情监测 

分 类 号：R951[医药卫生—药学]