原料药注册资料翻译策略TheTranslaionSraegyforAPIRegisraionDaa_开题报告

•Active Pharmaceutical Ingredient (API)(or Drug Substance)[1][2]: Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body. APIs can be used for clinical application only if they are processed into pharmaceutical preparations.

••In the world API market, the European Union and the US market are the main export markets for Chinese API enterprises, which is commonly referred to as the regulation market. In order to enter into these regulation markets, Chinese companies need to follow the drug registration regulations and the GMP requirements in these countries. Chinese APIs are likely to step into the regulation market only if they cross the basic threshold of regulation and GMP [3] .Of course, APIs which are produced by foreign manufacturers want to enter into the Chinese market must be approved by CFDA and meet the requirements of domestic registration regulations [4]. Therefore, the demand for registration data translation is increasing in the field of import and export trade for API. The registration material of API mainly includes a series of technical documents, such as pharmaceutical research and development, quality research and GMP production, which belongs to the category of scientific and technological style [5]. And the main character of this style [6] is that the words are very accurate, very logical, precise, and very professional. Therefore, in translation process of science and technology style, we must take these characteristics into account, and only in this way can translation for science and technology be appropriate and accurate.

•Translation theory for Science and technology English is the rule from summary of translation process for scientific and technological English, and the translation theory has very important guiding significance for translation practice[6]. Unfortunately, compared with the development of literary translation theory, scientific and technological translation has lagged behind in theoretical research in recent years [7].  To analyze its reason mainly has two aspects: one reason is that the translation of science and technology has stronger practicability and pertinence, so the translation theory of science and technology research is basically trapped in technical and operational aspects of translation. The other is that the personnel who are engaged in the translation of science and technology acknowledge macro guidance of translation theory, but they pay more attention to translation practice skills, are more willing to understand the knowledge of science and technology, and not willing to improve the translation theory, so the research on science and technology translation is restricted by the disconnection between theory and practice. Therefore, the translation of science and technology English has always been a difficult point in the translation field. From the view of the specific work of API registration, the people who are currently engaged in the registration translation work are the technicians who have the technical background, but they do not have a complete  knowledge structure of English, without any necessary translation training, and is not sensitive to the differences between English and Chinese languages and so on, all above reasons lead them to feel overwhelmed in the face of more professional documents that need to be read and translate, if they turn to English major students for help , they will still fail. Because lacking of technical background and not understanding the professional content of translation is also a major obstacle for English major students to their technical translation [8].

•At present, there is very little research on the translation strategy for API registration materials, and I will take some typical registration translation encountered in previous work for examples, according to the linguistic features of this kind of data, and combining with the application of the Skopos Theory in Sci-tech translation [9] [12] [13] and the application of translation tools [10] , aim to provide some translation skills and strategies for API registration workers in the field of English-Chinese translation. It may bring some work convenience and inspiration.

•Skopos Theory [11]：Skopos Theory was brought up by German scholars in the 1970s， its main representative is Reiss, Vermeer and so on. Reiss was based on the three language functions of Buhler, divided all texts into three types: (1) Content-focused text; (2) Form-focused text; (3) Appeal-focused text; And they are also called：(1) Informative text；(2) Expressive text；(3) Operative text. According to her translation typology, the registration material of API belongs to the Informative text, and the main function of informative text is to let readers understand the things and scenes in the real world, to convey information, knowledge, view and so on. However, the key point of the communication is the content or topic, and the choice of words and style is secondary. On the basis of above standpoint, Skopos Theory of further development think that translation is an intercultural communication behavior with purpose based on the source text. The most important factor to determine the purpose of translation is the audience, who is the target receiver of the translation, and every kind of translation will point to a certain audience. The Skopos Theory includes Skopos rule, Coherence rule and Fidelity rule: Skopos rule is mean that translation is a purposeful communicative activity, and the communicative purpose in the translation culture plays a leading role in the whole translation process; Coherence rule is mean that the translation must be coherent, and understandable to the reader, and meaningful in the target language communication environment; Fidelity rule is mean that the original content, foreign culture and linguistic stylistic style can be conveyed faithfully, it also includes the necessary adjustments for achieving the expected function of the translation. Among these three rules, Fidelity rule is subject to Coherence rule, meanwhile Coherence rule and Fidelity rule are all subject to Skopos rule. This theory provides translators with flexible translation standards, and the translator can adjust the translation criterion and strategies according to the actual situation to be fit for translation purpose behavior. The translator also can add and delete the contents, adjust words, paragraphs and chapters in different source text according to the requirements from the audience, and in order to achieve more communicative purpose of translation.

Outline 

1.Introduction

1.1.Research Background 

1.2.Research Object

2. Characteristics of API Registration Data

2.1. Features of Words 

2.2. Features of Sentences

2.3. Features of Texts

3. Skopos Theory and API Registration Data Translation

3.1.Skopos Teory

3.2.Application of Skopos Theory in API Registration Data Translation  

4. Translation Strategies for API Registration Data 

4.1 Translation Strategies Base on Skopos Theory

4.2 Translation Strategies Base on translation tools

4.3 Other Translation Strategies

5.Conclusion

References 

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