药品质量标准是国家对药品质量规格和检验方法所作的技术规定,是药品生产、经营、使用、检验和管理部门必须共同遵守的法定依据,新药在进入临床前的研究过程中,其质量标准的制订就是一项非常重要的研究内容,新药批准上市后,则是国家对药品质量进行监督检验管理的技术法规,因此药品质量标准本身具有法定性、强制性 The drug quality standards are the technical regulations stipulated by the State for drug quality specifications and test methods, and are the legal basis for drug production, management, use, inspection, and management departments to jointly abide by. The quality standards of new drugs are in the preclinical research process. Formulation is a very important research content. After the new drug is approved for listing, it is the state’s technical regulation on the supervision, inspection and management of drug quality. Therefore, the drug quality standard itself is statutory and mandatory.