药品注册标准初探

目的：探究药品注册标准的内涵和外延。方法：采用认识分析方法，通过对质量及药品质量认识，论述分析药品质量的实质、药品质量指标、药品标准组成及相关要求、药品标准在药品生命周期各环节作用，研讨药品注册标准的内涵与外延，以及对提高药品质量的促进作用。结果：药品质量的实质是药品临床应用的安全性和有效性，药品标准由药品代用质量指标及检验方法和有关要求组成，并在一定程度上关联药品的有效性和安全性。结论：药品注册标准具有国家标准和企业标准属性，其企业标准属性，在适应企业生产条件和追求质量差异、促进质量提高方面有其独特的作用，但标准管理及适用等尚需建立药品标准管理与评价制度，以构建和完善药品标准体系。

A Preliminary Study on Drug Registration Specifications

Objective:To explore the connotation and extension of drug registration specifications. Methods:Cognition analysis method was used to discuss and analyze the essence and indicators of drug quality, the composition and requirements of drug specifications, the role of drug specifications in every aspect of drug''s life cycle, the connotation and extension of drug registration specifications, as well as the role of promoting and improving the quality of drugs based on the understandings of the quality and drug quality. Results:The essence of drug quality is the safety and efficacy of clinical application of drugs. Drug specifications consist of drug substitute quality indicators, test methods and relevant requirements, and to some certain extent, they are related to effectiveness and safety of the drugs. Conclusion:The drug registration specifications have the attributes of national and enterprise specifications. The enterprise specification attribute has its unique role in adapting to the production conditions of the enterprise, pursuing the quality differences, and promoting the quality improvement. However, the specification management and application still need to establish the drug specification management and evaluation system in order to build and improve the drug specification system.