摘要
按照国务院《关于改革药品医疗器械审评审批制度的意见》（国发[2015]44号）和中共中央办公厅、国务院办公厅关于深化审评审批制度改革鼓励药品医疗器械创新的意见》（厅字[2017]42号）要求,国家药品监督管理局积极推进药品审评审批制度改革,在固体仿制药质量疗效一致性评价和注射剂质量再评价方面开展了扎实有效的工作。
Editor＇s Note： According to the requirements of the ＂Opinions on reforming the review and approval system for drugs and medical devices＂ （[2015] No. 44） issued by the State Council of China and the ＂Opinions on deepening the reform of review and approval system and encouraging the innovation of drugs and medical devices＂ （[2017] No. 42） issued by both General Office of the Communist Party of China and General Office of the State Council, China Food and Drug Administration （CFDA） actively promoted the reform of the review and approval system for drugs and carried out solid and effective works on the consistency evaluation of the quality and efficacy of solid generic drugs and the re- evaluation of the quality of injections.
出处
《中国药事》
CAS
2018年第9期1188-1196,共9页
Chinese Pharmaceutical Affairs
