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湘食药监发[2007]12号各市州食品药品监督管理局、卫生局:为加强上市药品的安全监管,规范药品不良反应报告和监测管理,保障公众用药安全,根据卫生部与国家食品药品监督管理局《药品不良反应报告和监测管理办法》(局令第7号)的要求,省食品药品监督管理局、省卫生厅制定了《湖南省实施(药品不良反应报告和监测管理办法)细则》(试行),现印发给你们,请遵照执行。
Xiang Food and Drug Administration [2007] 12 State Food and Drug Administration of each city, the Health Bureau: In order to strengthen the safety supervision of listed drugs, standardize adverse drug reaction reports and monitoring management, to ensure public safety of drugs, according to the Ministry of Health and the National Food and Drug Supervision and Administration of “Adverse Drug Reaction Reporting and Monitoring Management Measures” (Bureau Decree No. 7) requirements, the Provincial Food and Drug Administration, the provincial Health Department has developed “Hunan Province (Adverse Drug Reaction Reporting and Monitoring Management Measures) Rules ”(Trial), are issued to you, please follow the implementation.