目的 研究药品监管“四个最严”要求的提出、内涵及新时代落实相关要求应当统筹处理的问题。方法 结合新修订的《中华人民共和国药品管理法》相关规定,分别解析最严谨的标准、最严格的监管、最严厉的处罚和最严肃的问责的基本内涵和要求,分析新时代、新形势、新要求,提出应当高度关注的问题。结果与结论 “四个最严”揭示了药品监管的科学属性、现实路径、内在要求和保障机制。新时代落实“四个最严”要求,应当统筹好其与推动医药产业高质量发展的关系、与包容审慎监管的关系、与推进药品监管现代化的关系。
Abstract
OBJECTIVE To investigate the meanings of “the Four Strictest Principles” and the issues needed to be focused on during its implementation. METHODS The basic meanings and requirements of “the most rigorous standards, the most stringent supervision, the most severe punishment and the most serious accountability” were investigated respectively according to the relevant provisions in the newly revised Drug Administration Law. New conditions and new requirements were analyzed and relevant issues were proposed in the new era. RESULTS AND CONCLUSION “The Four Strictest Principles” reveal the scientific attribution, realistic path, inherent requirements and guarantee mechanism of drug supervision. More attentions should be paid to its relationship with promoting high-quality development of pharmaceutical industry, inclusive and prudent supervision, and promoting the modernization of drug supervision.
关键词
药品安全 /
药品监管 /
四个最严 /
药品管理法
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Key words
drug safety /
drug supervision /
the four strictest principles /
Drug Administration Law
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中图分类号:
R95
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