摘要
近年来,我国在药品审评审批过程中存在的问题日益凸显,主要体现为药品审评质量和效率有待进一步提高、药品审评积压比较严重、药品技术审评人员严重不足及批准文号泛滥等;国家食药监总局出台了诸多政策,国务院也发布有相关指导性意见以期解决上述问题,本文也对我国药品审评评审制度中诸如新药研发困难、《中华人民共和国药品管理法》的不足、临床试验和生物等效性试验由"审批制"改为"备案制"法律效力不足及药企对弄虚作假行为监管乏力等作了简要分析。
In recent years, the problems in the process of the drug examination and approval are becoming increasingly prominent, mainly involving the serious backlog of drug approval, the inadequate personnel of drug technical evaluation, and the flooding of approval document, etc.. Drug safety administration issued many policies.The state council also issued relevant guiding suggestions, expecting to solve the above problems, and improve the quality of drug examination and approval. In this paper, related issues involved in drug examination and approval system in China are briefly analyzed, i.e： the reason for the difficulties of new drug research and development in China, some problems in The Pharmaceutical Administration Law of the People＇s Republic of China, problems in the transformation of clinical trials and the bioequivalence test from ＂approval system＂ to ＂record system＂, and the difficulties for the enterprises in ensuring the authenticity of clinical trial data, etc..
出处
《医学与法学》
2016年第2期56-61,共6页
Medicine and Jurisprudence
关键词
药品
审评审批
改革
思考
drug
examination and approval
reform
reflection
