Abstract：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.
钟露苗. 药品上市许可持有人在药品全生命周期中安全风险主体责任的探讨[J]. 中国药物警戒, 2019, 16(11): 666-669.
ZHONG Lumiao. MAHs’ Principal Responsibilities for Safety Risk during the Whole-life Cycle of Drugs. Chinese Journal of Pharmacovigilance, 2019, 16(11): 666-669.
2019, Vol. 16 
