Medical translation
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Medical translation is the translation of technical, regulatory, clinical or marketing documentation, software or training curriculum for the pharmaceutical, medical device or healthcare fields. Most countries around the world require that literature and labeling associated with medical devices or pharmaceuticals sold be translated into the national language(s). In addition, documents necessary to conduct clinical trials often require translation in order for local clinicians and patients and regulatory representatives to be able to read them. Regulatory approval submissions typically have to be translated as well.[1][2]
Pharmaceutical translation The pharmaceutical translation refers to the translation of any text within or related to the pharmaceutical field. The translation must be carried out linguistically and based on the target terminology. Any mistranslation can lead to wrong understanding of the meaning and therefore to possible health related problems, injury and even death.The pharmaceutical translations include the translation of prospects, pharmaceutical content, pharmaceutical devices, content related to the production of medicines, or any text related to the pharmaceutical industry, pharmaceutical company, pharmaceutical product or pharmaceutical journal. The translator who carries out a pharmaceutical translation has to adapt the source text to the target one, and must be familiar with the pharmaceutical terminology of both source and target languages. In order to translate pharmaceutical content, subject matter knowledge is required, as well as training. The terminology in pharmaceutical translations is strict and must be followed accordingly. The CAT tools can help the translators with the consistency, but they still have to be up to date with the latest terminology approved and with the newest pharmaceutical research results and pharmaceutical technology. Therefore, the pharmaceutical translation must be carried out only by translators who are highly experienced in the pharmaceutical field and who properly understand and are able to adapt in a proper way the pharmaceutical terminology of two different languages.[3]
Aside from linguistic skills, it requires specific training and subject matter knowledge in order to translate medical content. This is because of the highly technical, sensitive and regulated nature of medical texts.
Process
Because medical translation is typically a multi-step process, it is usually carried out by a translation agency which oversees all project management and the linguistic team.[citation needed] Steps in the process can include:
• Extraction of text from source format
• Translation – the conversion of the source language text to the target language text
• Editing – reading and revision by a separate person to assure adherence to approved terminology and the proper style and voice.
• Publishing – the translation is put back into the original format (e.g., Word document, Web page, e-learning program)
• Proofreading – this ensures that the formatted translation displays correctly with no corrupted text, has proper punctuation and line and page breaks are correct.
• In-country review – a native-speaking expert reviews the translation to ensure that it meets all specifications and product or therapy specifics.
Quality and Standards
Given the life and death nature of medical texts, there is a strong emphasis on translation quality.[4]
The international medical industry is highly regulated and companies who need to translate their documentation typically choose translation agencies that are certified or compliant with one or more of the following standards:
- ISO 9001 – quality system standard
- EN 15038 – European standard for translation vendor quality (Translation-quality standards)
- ISO 13485 – overarching standard for manufacture of medical devices