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本文就中药新药申报资料中有关处方、生产工艺和质量标准方面存在的问题作了剖析,为新药研制单位完善申报资料提供参考。
This article analyzes the problems concerning prescriptions, production techniques and quality standards in the new drug application materials for Chinese medicines, and provides reference for the new drug development units to improve their application materials.