关键词: 药品再评价, 英国, 德国

Abstract: 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.

Key words: drug reevaluation, United Kingdom, Germany