In order to continue to explore and improve the working methods of risk-based drug inspection in China,this paper describes the institutions,regulatory documents and implementation procedures related to drug inspection in the United States,and analyzes the shortcomings in the implementation of risk-based drug registration inspection in China through comparison.Some specific suggestions are put forward to promote more scientific and standardized risk-based drug registration inspection in our country.
关键词
基于风险/药品检查/注册核查/对比分析
Key words
Risk-based/Drug inspection/Registration/Comparison and analysis
维普
万方数据