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中国中药新药研究审批的现状和展望张世臣（北京卫生部药政局，００７２５）王北婴（北京卫生部药品审评中心，１０００５０）新药的审批管理，是药品质量监督管理的重要一环，代表着一个国家新药研究及药品质量的水平。根据《中华人民共和国药品管理法》，关于新药的临床...
Current status and prospects of research and approval of Chinese new drugs for Chinese medicines Zhang Shichen (Beijing Bureau of Health, Pharmaceutical Affairs Bureau, 200725) Wang Beiyi (Beijing Drug Evaluation Center, Ministry of Health, 100050) The approval of new drugs is an important part of drug quality supervision and management, representing a country New drug research and drug quality levels. According to “The People’s Republic of China Drug Administration Law,” on the clinical aspects of new drugs ...