摘要
药品审评专家咨询制度是药品审评科学性与公正性的重要制度保障。本文概括了我国药品审评先后经历的药品审评委员会、专家库与专家咨询委员会的专家咨询制度各自的特点,比较研究了美国、日本、英国、瑞士等国家药品审评专家咨询制度的异同,并着重分析了我国现有专家咨询委员会制度在利益冲突、信息公开等方面的制度进展。最后,着眼于我国药品审评审批制度的总体改革目标,对如何进一步完善药品审评专家体系、拓宽专家咨询渠道进行了思考与展望。
Expert advisory committee system is an important institutional assurance for scientificity and impartiality of drug review. This paper summarized the characteristics of drug review committee,expert database and expert advisory committee which our country has experienced. Drug review expert advisory committee systems of the America,Japan,British and Swiss were compared. Focus was put on the development of our present expert advisory committee in aspects of interest conflict and information disclosure. In the end,innovations about how to further improve drug review expert system and expand expert advisory channel were pondered and expected in depth.
作者
李峰
吴晓明
LI Feng;WU Xiao-ming(School of International Pharmaceutical Business,China Pharmaceutical University,Nanjing 211198,China;Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2018年第18期2081-2087,共7页
Chinese Journal of New Drugs
关键词
药品审评
专家咨询
利益冲突
公开论证
drug review
expert advisory
interest conflict
public meetings
