国内外效益风险评价体系与评估要点研究

Research of domestic and foreign benefit-risk assessment system and evaluating outline

目的研究国外效益风险评价体系与评估要点,为进一步研究效益风险评价提供建议。方法查阅国内外相关文献,对欧盟、美国、日本、加拿大、澳大利亚与国际管理科学创新中心关于药品效益风险的评价体系与要点进行研究。结果各国在评价对象与方法等方面存在着一定差异,但通过构建合理的评价体系,纳入多方意见,保证了评价结果的公开透明。结论建议开展药品效益风险方法学与实证研究,为构建符合我国监管需要的评价体系提供思路。

Objective To study the benefit-risk assessment system and major points of foreign countries, and to provide suggestions for further study of benefit-risk assessment. Methods Through reviewing relevant literatures at home and abroad, we studied the drug benefit-risk assessment system and evaluated the major points of the European Union, the United States, Japan, Canada, Australia and the International Management Science Innovation Center. Results Differences existed in the evaluation objects and methods among countries. Through building a reasonable evaluation system and incorporating multiple opinions, the evaluation results were managed to be open and transparent. Conclusion We suggest conducting research on pharmacological benefit-risk methodology and empirical study and try to establish an assessment system consistent with the supervision in China.