A Report On Chinese-English Translation Of Technical Requirements For The Pharmaceutical Research And Evaluation Of Chemical Drugs Marketed Overseas But Not Marketed In China (Trial)

This translation report is based on Chinese-English translation of Technical Requirements for the Pharmaceutical Research and Evaluation of Chemical Drugs Marketed Overseas but Not Marketed in China(Trial)(hereinafter referred to as the Requirements)issued by the Drug Evaluation Center(CDE)of National Medical Products Administration(NMPA)on March 9,2021.It explains the requirements of drug registration on drug substances,manufacturing process,formulation process,impurity control,quality control,and so on in great detail.The source text is organized under a precise,coherent,and clear discourse as a typical technical text.It has the distinctive characteristics of accurate language,strict formality,objective statements,strong logic,and professionalism.Under the direction of Catford’s Translation Shift Theory,the translator analyzed the shifts and strategies employed in translation.When translating numerous terms and titles of official documents,with the help of parallel texts and specialized dictionaries,the translator made level and category shifts where it is necessary.As for the category words in the source text,the translator mainly used omission to convey information concisely.To translate large amounts of no-subject sentences and active voice,the translator adopted shifts from active voice to passive voice and shifts from personal subject to impersonal subject.For the translation of complex sentences,the methods of division and combination are crucial to express the logical relations between different clauses clearly in the target language.At the textual level,substitution and reference helped guarantee the cohesion of the text.Through this translation practice,the translator found that applying Catford’s Translation Shift Theory as to the translation practice is highly operable and can better ensure the faithfulness and accuracy of the translation.Moreover,specialized knowledge and abundant reference are crucial to translating technical text precisely.This report is hoped to provide more practical translation skills and methods for technical text translation in the pharmaceutical field.