英国和德国的药品再评价工作经验及启示

摘要

Objective To put forward enlightenment for the drug reevaluation act in China through comparing the reevaluation of marketed old drugs in the United Kingdom and Germany. Methods The reevaluation causes, methods, problems encountered during the evaluation process and the reevaluation results in the United Kingdom and Germany were reviewed. Results The marketed drug reevaluation in both countries was conducted under the mandatory requirements of the European community, the two countries adopted similar but not identical evaluation methods.The evaluation process lasted for more than 20 years in Germany, while the reevaluation project was generally completed in the United Kingdom within the time limit stipulated by the European community through many adjustments to the evaluation methods. Conclusion A feasible reevaluation strategy should be developed for the reevaluation of marketed old drugs, the quality and pace of evaluation should be balanced, and it is necessary to design a scientific policy for the reevaluation process to avoid regulatory conflicts or legal disputes.%目的 通过比较英国和德国开展的上市后老药的再评价工作,提出对我国药品上市后再评价工作的启示.方法总结德国和英国开展已上市药物再评价的原因、评价方法、评价过程中遇到的问题和评价结果.结果两国的老药再评价行动都是在欧共体相关法令的强制要求下进行的,两国采用了相似但不完全相同的评价方法.德国的再评价工作进行了二十多年,英国通过多次调整评价方法,基本在欧共体规定的时限内完成了再评价.结论上市后药品再评价应制定合适的再评价策略,要注重质量和速度的平衡,需要对再评价工作进行科学的制度设计,避免出现监管冲突或法律纠纷.