摘要
目的促进我国药品上市许可持有人安全风险主体责任意识的提升。方法通过分析上市前和上市后药品安全风险产生的原因,借鉴国外药品上市后的监管模式,助力提升我国药品上市许可持有人安全风险主体责任意识。结果与结论在药品全生命周期中,药品上市许可持有人作为研发、生产和经济获益的主体,应该全面承担起药品安全风险的主体责任。
Objective To enhance MAHs’awareness of principal responsibilities for drug safety risks.Methods The causes of pre-marketing and post-marketing risks were analyzed.The strengths of regulatory models overseas were summarized.Results&Conclusion In the whole-life cycle of drugs,MAHs,as the main body of research and development,production and economic benefit,should bear the principal responsibilities for drug safety risks.
作者
钟露苗
ZHONG Lumiao(Hunan Center for Drug Evaluation and Authentication and ADR Monitoring,Changsha Hunan 410013,China)
出处
《中国药物警戒》
2019年第11期666-669,677,共5页
Chinese Journal of Pharmacovigilance
