药品是人们与疾病作斗争的武器,管理有方,用之得当,可以为人民防病治病,如失之管理,粗制滥造,质量低劣,则危害人民身体健康,甚至危及生命,因此世界各国政府卫生部门都设有药政管理机构,负责颁布药品管理的法令政策,进行监督管理,以保证人民用药的安全有效,所以新药在作为商品上市前都要经过药政机构的严格审批,必需完成按照规定所需的各项技术资料,这样反复审批,补充数据,需要较长时间,通常一个新药从研制到作为商品上市,常常需要数年时间,使得医药工业成为世界上最受法令与规章约束的工业之一,我国过去药政管理较松,新药上市比较随便,近几年来药政管理部门逐渐完善了管理新药的规章制度,使得新药研制工作逐渐走上正规化的道路.中试研究是新药研究过程中不可缺少的一环,但过去人们对中试研究的任务缺乏理介,对其重要性认识不够,错误的认为中试研究是可有可无的,我们院在六十年代曾着手筹建中 Drugs are the weapons that people fight with diseases. They are well-managed and well-used. They can prevent and cure diseases and prevent and treat diseases, such as management, abuse and poor quality, endanger people’s health and even life-threatening. Therefore, governments of all countries in the world Health departments have set up a drug administration, is responsible for the promulgation of drug administration laws and policies, supervision and management, in order to ensure the safety of people’s medication, so the new drug as a commodity before going through the strict approval of the pharmaceutical institutions must be completed in accordance with It requires a long period of time to approve and replenish data repeatedly. Usually, a new drug needs to be developed from a market to a commodity market for several years, making the pharmaceutical industry the most decree and regulation in the world As one of the industries, in the past, the administration of medicine in our country was relatively loose and the listing of new drugs was rather arbitrary. In recent years, the administrative departments of medicine gradually improved the rules and regulations governing new drugs, making the development of new drugs gradually onto the path of formalization. The research process is an indispensable part, but in the past, people lacked a reasonable understanding of the tasks of pilot studies, did not fully understand their importance, Misconception that pilot studies are dispensable and our institute started the construction in the sixties