药品注册现场核查模式探讨

规范药品注册必须从源头抓起。如何确保药品研制数据的真实,保证药品注册环境的公平、公正,是省局药监部门药品注册管理工作的重心。本研究主要从我国药品注册现场核查的现状出发,纵观美国FDA的药品注册管理体系及现场核查状况,结合我国现行的药品注册法规,探讨药品注册现场核查的新模式、新方法,旨在为药品监管工作提供有益的新思路,从而更好地促进我国医药产业的健康发展,保证人民群众用药安全有效。

Investigation on mode of on-site examination in drug registration

Standardization of drug registration must be done from the beginning of drug research and development.How to affirm the submitted data's reality and ensure equity and justice in drug registration is an important part of work of the Provincial Drug Administration Authorities.New modes and methods of on-site examination of drug registration were investigated in our study,according to current situation of on-site examination in our country,the drug registration administration system and on-site examination situation of U.S. Food and Drug Administration (FDA) and combined with regulations on drug registration in our country.Our aim is to provide new ideas for drug administration,to enhance the development of our country's pharmaceutical industry,and guarantee that safe and effective drugs are available to our people.