A Report On ICH Guideline Q3C(R6) On Impurities:Guideline For Residual Solvents Step 5-an Analysis Based On The "Comprehension,Expression And Adaptation"(CEA) Framework

In 2017,the State Food and Drug Administration officially became a member of the International Human Drug Registration Technical Coordination Committee(ICH).In order to be in line with the international examination and approval of new drugs,it is urgent to translate the document of ICH guidelines.The analysis object of this translation report is ICH guideline Q3C(R6)on impurities:guideline for residual solvents Step 5,which is based on the theoretical framework of "comprehension","expression" and "adaptation" put forward by Professor Li Changshuan.The logical thinking,internal tools and external tools are included in the "comprehension".And the "expression" part gives a successive analysis mainly from three levels-word,sentence and paragraph.Word aspect mainly involves word selection,conversion of word class and the processing of abstract words.Based on the textual characteristics of the Guiding Principles document,this paper will analyze the three aspects of segmentation and integration,active and passive conversion,and information focus.In the aspect of paragraph,the author mainly discusses the problem of cohesion.The last part is about "adaptation",mainly from the overall view and flexible deletion of these two aspects.The author guided by the theoretical framework thoroughly analyzed the difficulties in the process of translation and gradually internalized the theoretical framework,thus guiding the translation practice in the future.