我国《药品管理法》规定,研制新药必须向国务院卫生行政部门或省、自治区、直辖市卫生行政部门报送研制方法、质量标准、临床前药理及毒理研究等有关资料,经批准后方可进行临床研究。申报生产新药,同样需提供质 China’s “Drug Administration Law” provides that the development of new drugs must be submitted to the health administrative department of the State Council or the provincial, autonomous regions and municipalities directly under the central government health administrative departments to submit research and development methods, quality standards, preclinical pharmacology and toxicology research and other relevant information, after approval before clinical the study. Declare the production of new drugs, the same need to provide quality