国外定量药品风险-效益评价方法简析

Brief Analysis of Foreign Quantitative Risk-Benefit Assessing Method of Medicines

目的分析和比较已有药品风险效益评价方法,为我国药品风险-效益评价提供参考。方法通过查阅国外文献,应用文献研究和比较研究的方法进行分析。结果 FDA、EMEA已十分重视药品风险-效益评价,目前各种风险效益评价方法都存在自身的优势和劣势。结论监管机构应努力研究和探索适用于整个药品生命周期的、标准化的风险-效益评价方法。

Objective To analyze and compare the existed medicine risk-benefit assessment methods and provide suggestions to our medicine risk-benefit assessment. Methods Literature study and comparative study were used to analyze and compare the foreign materials. Results FDA and EMEA has already attached much importance to medicine risk-benefit assessment, and now each of the existed risk-benefit assessment methods has its own strengthness and weakness. Conclusion Regulatory agencies should try to study and explore a standard method that can apply to the whole life period of medicines.