我国自改革开放以来,新药研究开发呈现良好的发展态势。1985～1993年共批准新药(西药)587个,平均每年65个。1994～1998年批准新药(西药)情况见表1。但目前我国新药申报中也存在着一些问题,主要表现为仿制品种、改革剂型的品种多,创新药少,药品开发仍停留在以仿制为主的阶段,低 Since the reform and opening up in our country, the research and development of new drugs has shown a good momentum of development. Between 1985 and 1993, 587 new drugs (western medicine) were approved, with an average of 65 per year. The approval of new drugs (western medicine) from 1994 to 1998 is shown in Table 1. However, there are still some problems in the declaration of new drugs in our country. The main problems are the imitation varieties, the varieties of reforming dosage forms and the lack of innovative drugs. The drug development still stays in the stage of imitation-based and low