药品评价中的获益风险评估

Benefit-risk assessment in drugs evaluation

获益/风险评估存在于药品全生命周期管理中,也是药品注册申请监管决策的重要步骤。药物研发或监管各方一直在探讨科学、合理、可行的获益/风险评估方法。经过二十余年的发展,获益/风险评估已越来越科学、客观、结构化。本文从定性及定量两个方面,对不同监管机构上市注册申请评价过程中获益/风险评估方法进行综述,对比不同监管机构监管决策中的定性、定量获益/风险评估方法,并分析监管机构认可的获益/风险评估方法的特点及未来发展趋势。

Benefit-risk assessment exists in the whole life cycle management of drugs,and it is also an important step in the regulatory decision-making of drug registration application.Drug research and development institutions and regulatory agencies have been exploring scientific,reasonable and feasible benefit-risk assessment methods.After more than 20-year’s development,benefit-risk assessment has become more and more scientific,objective and structured.We reviewed and compared the benefit-risk assessment methods in evaluation process of drugs’registration application in different regulatory agencies,from qualitative and quantitative aspects.In addition,we analyzed the characteristics and development trend of benefit-risk assessment methods recognized by regulatory agencies.