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新修订的《中华人民共和国药品管理法》第七十一条规定“国家实行药品不良反应报告制度。药品生产企业、药品经营企业和医疗机构必须经常考察本单位所生产、经营、使用的药品质量、疗效和反应。发现可能与用药有关的严重不良反应,必须及时向当地省、自治区、直辖市人民政府药品监督管理部门和卫生行政部门报告。具体办法由国务院药品监督管理部门会同国务院卫生行政部门制定”。2004年3
The newly revised Article 71 of the “Drug Administration Law of the People’s Republic of China” stipulates that “the state shall implement an adverse drug reaction reporting system.” Pharmaceutical manufacturing enterprises, pharmaceutical enterprises and medical institutions must regularly inspect the quality of drugs produced, operated and used by their units , Efficacy and response.It is found that serious adverse drug reactions may be reported to the drug regulatory department and health administrative department of the people’s government of the local province, autonomous region or municipality directly under the Central Government in a timely manner.The specific measures shall be formulated by the drug regulatory department under the State Council together with the health administrative department under the State Council ". 2004 3