从药害事件的处理看我国药品监管问责制改革

Reform of administrative accountability in drug supervision from the view of the dispose of ADE

从当前药害事件的处理来看,我国药品监管行政问责存在问责对象模糊不清、政治色彩浓厚、以追责代替回应以及公开度与透明度不足等问题。我国药品监管亟需在理念上实现从安全监管到风险监管的转换。为推进药品监管问责的法制化改革,在实践中应做到于法有据、权责一致、全面问责、公开透明以及社会共治。

According to the current issues of the drug supervision, there exist in the drug administrative accountability problems like the difficulty in finding the liable party, with too much politics, inefficiency in the response mechanism and dynamics and the lack of transparency in the handling of the case. Drug supervision^s idea in our country needs to realize the transition from safety supervision to risk supervision. In order to enhance the legalization of the drug supervision, it is necessary to act with lawfully recognized evidence, align power with responsibility, be accountable for every administrative action, be transparent and involve multiple participation.