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我部根据《中华人民共和国药品管理法》制定的《新药审批办法》实施已经两年,实践证明,《办法》对促进我国新药研制和医药工业的发展,提高新药审评的水平以及用药安全、有效,起了积极作用.为了逐步完善我国的新药审批管理工作,在《新药审批办法》的执行过程中,我们听取了各方面对新药审批管理的意见和建议,于去年上半年征求了全国各地的意见,并将这些意见汇总整理,在去年
It has been two years since the implementation of the “Measures for the Examination and Approval of New Drugs” formulated by the Ministry of the People’s Republic of China under the Drug Administration Law of the People’s Republic of China. Practice shows that the Measures are of great importance in promoting the development of new drugs and the pharmaceutical industry in our country, raising the level of new drug reviews and drug safety, Effective, and played an active role.In order to gradually improve China’s drug approval management, in the “new drug approval approach” in the implementation process, we heard all aspects of the approval of new drug approval opinions and suggestions in the first half of last year for the national Views all over the place, and put these comments together in order last year