欧美药典及ICH元素杂质指导原则增修订历程及对中国药典的启示

目的：为2020年版《中华人民共和国药典》四部元素杂质通则及指导原则的增修订提供借鉴和参考。方法：查阅ICH Q3D及欧美药典中收载的元素杂质通则及指导原则的增修订背景，梳理它们的增修订历程。结果：欧美药典均制定了详细的ICH Q3D指导原则本地区实施策略，元素杂质通则和指导原则几经修订完善，目前已与ICH Q3D一致。结论：《中华人民共和国药典》可借鉴欧美药典实施元素杂质相关控制要求的时机及策略，结合我国国情，增订相关通则及指导原则。

The Revision History of the European and United States Pharmacopoeias and ICH Elemental Impurity Guidelines and the Enlightenment to the Chinese Pharmacopoeia

Objective:To provide references for the revision of general principle and guidelines for elemental impurities in the Chinese Pharmacopoeia (2020 edition) volume IV. Methods:The background of the revision of general principles and guidelines for elemental impurities included in ICH Q3D and European and United States Pharmacopoeias was reviewed. Results:The European and United States Pharmacopoeias have developed detailed strategies for the implementation of ICH Q3D guideline. The general principle and guidelines for elemental impurities have been revised and improved and are now consistent with those of the ICH Q3D. Conclusion:Chinese Pharmacopoeia can learn from the timing and strategies of implementing the elemental impurities control requirements in the European and United States Pharmacopoeias, and combine the national conditions of China to develop the corresponding general principle and guidelines.