What is medical and pharmaceutical translation? Reasons why translation is difficult and points to consider when selecting a translation service provider.

1. What is Medical Translation and Pharmaceutical Translation?

Human Science, which provides translation services in various fields such as IT, is not only a translation company that handles general medical translations, but also a technology company that develops and operates various translation-related technologies, offering a wide range of solutions.
https://www.science.co.jp/localization/industry/medical/index.html
In this column, we will discuss medical and pharmaceutical translation and points to consider when selecting a translation service provider.

 

■Target of Medical Translation
On the introduction page of Human Science's medical and medical translation services, we introduce the translation targets in the medical industry separately as "Pharmaceutical and Medical Translation Services" and "Medical Device Translation Services".
https://www.science.co.jp/localization/industry/medical/index.html

As the most important aspect of "Pharmaceutical and Medical Translation," there is medical translation of documents created by pharmaceutical companies, such as clinical trial-related documents and safety reports to regulatory authorities (reports on pharmacological and pharmacokinetic tests, toxicity tests, safety tests, summaries of investigational drugs, investigational plan documents, informed consent documents, comprehensive reports on clinical trials, case reports, etc.).

In addition, we also provide academic and scientific medical translation services for Japanese translations of articles and conference materials published in English medical journals, as well as English translations of articles written by Japanese doctors and diagnostic and treatment guidelines created by Japanese medical societies.

"Medical device translation" also includes the translation of various manuals such as documents created during development, manufacturing, and approval, as well as instruction manuals and catalogs.

In addition, there is a field that has been increasing in demand in recent years, which is the field of bio-related (cell analysis, gene analysis, equipment and laboratory supplies for that purpose, etc.).

In addition, there are new trends in the form of materials produced by medical-related companies, such as internal educational materials and video content that incorporate animation and videos.

 

■Demand and Future Prospects of Medical Translation
In recent years, the medical industry has received a great deal of attention amid the COVID-19 pandemic. In fact, PCR testing equipment, vaccine development, ECMO, and artificial respirators have become significant topics. So, what is the actual market situation? It seems to vary depending on whether it is the pharmaceutical industry or the medical device industry, and whether it is domestic or global. However, as a whole, the medical industry has relatively stable demand and is less influenced by economic conditions, and there also appears to be a stable demand for translation.

 

■Is a qualification necessary for medical translation?
When it comes to qualifications in the medical field, you may first think of qualifications for doctors or pharmacists. However, it is not realistic for active professional translators or those aspiring to be professional translators to obtain the above qualifications, especially a medical license. Therefore, I would like to introduce the JTF Translation Certification, which includes the field of medical pharmacy as a means to demonstrate the practical translation skills. Grades 1 and 2 are considered difficult with a pass rate of less than 5%, and it seems to be a public proof of the practical translation skills in the field of medical pharmacy.

However, even without qualifications, many people who have studied medicine, pharmacy, biology, biochemistry, etc., or have work experience in pharmaceutical companies, CROs, medical device manufacturers, medical publishing companies, medical advertising agencies, etc., have accumulated expertise and are involved in translation.

In addition, in actual translation work, you may not always be assigned projects that perfectly match the fields you studied for certification exams. When carrying out tasks, it is important to adhere to various rules specified by clients, such as using designated translation tools, and to be familiar with them. High speed and accuracy are required, and these qualities often rely more on practical experience and a proactive attitude rather than just holding qualifications.

 

■Skills Required for Medical Translation
Language Proficiency
Regarding the language proficiency required for medical translation, we will omit the explanation about English proficiency levels as it does not differ significantly from other practical translations. However, we will introduce the uniqueness of English in medical translation here.

As an example of English translation, when submitting a paper in English to overseas medical journals, you must be familiar with the structure and unique expressions of the paper. In addition, each journal has submission guidelines that specify the writing style and format in detail. Japanese people may have a tendency to think, "If the content is good, they might allow some deviation in style..." However, in reality, deviating from the style can be a hindrance and may prevent the paper from passing the peer review process.

In addition to the above medical papers, which also apply to Japanese translations, there are unique formats, styles, and expressions for documents related to clinical trials, safety reports, and other pharmaceutical documents, and translations that adhere to them are required.
On the other hand, for newsletters, white papers, catalogs, and other medical device documents, it is necessary to accurately translate texts that incorporate marketing expressions while maintaining a high level of expertise.
Furthermore, for subtitles and dubbing translations in videos such as doctor's lectures, panel discussions, and training for doctors and internal company use, it is necessary to reduce the number of characters and make the main messages, including specialized content, clear and easy to understand for listening and reading.

Specialized Knowledge
While technical translation in general requires expertise, specialized knowledge required for medical translation is extensive and deep.
Here, we will specifically list each medical field below.

 

 

In each of these areas, new drugs and medical devices are developed, academic societies engage in activities such as establishing diagnostic guidelines, doctors perform medical procedures and submit papers, and there are literature, books, and scientific journals.

These documents and others that are generated by these are all highly specialized.

When translating, specific knowledge and skills are required. For translation related to pharmaceuticals, knowledge of clinical trials is necessary. For translation of medical papers, familiarity with medical knowledge and academic papers is required. For translation related to medical devices, in addition to the relevant medical field, familiarity with application-related documents, manufacturing operation manuals, and user manuals is necessary. Depending on the type of medical device, knowledge of mechanics, optics, chemistry, and physics may be required. In addition, common foundational knowledge includes medicine, pharmacy, biology, biochemistry, and statistics.

However, it goes without saying that mastering all of these at once is a daunting task, and even skilled translators typically build their expertise and track record in a specific field, such as the cardiovascular domain, and then expand into new areas based on their experience and know-how.

2. Reasons why medical translation and pharmaceutical translation are important

The situation has changed due to the COVID-19 pandemic since the beginning of 2020, but the trend of increasing numbers of foreign visitors and foreign workers to Japan in recent years before the pandemic is expected to remain a significant flow in the long term. It is not difficult to imagine that it would be beneficial for people living in or visiting Japan to have medical information provided in their own language, such as hospitals and pharmaceuticals. From this, I believe we can recognize the significance of medical translation.

However, there are many other important reasons for medical translation and pharmaceutical translation.

 

■Dealing with essential things related to life and health, not trends
Medical institutions, pharmaceutical manufacturers, CROs, medical device manufacturers, and sales companies of pharmaceuticals and medical devices all work with a sense of pride, knowing that they handle essential things related to life and health, not just trends, in their daily work. It goes without saying that documents generated in the field of medical and pharmaceuticals are important. Translating those documents quickly and accurately and delivering them to those who need them is a highly meaningful task.

 

■Contribution to the international introduction of pharmaceuticals and others
In the development of pharmaceuticals, the concept of "international collaborative development" has become common. According to the Ministry of Health, Labour and Welfare's document "What is international collaborative clinical trial (https://www.mhlw.go.jp/shingi/2007/07/dl/s0727-11d_0002.pdf)", it states that it is a clinical trial planned with the aim of developing and approving new drugs on a global scale, in which multiple medical institutions from different countries or regions participate and progress simultaneously based on a common clinical trial implementation plan. It mainly targets Phase III trials. In short, the concept is to eliminate the disparity in the timing of introducing new drugs between countries by conducting the development, clinical trials, and approval of new drugs simultaneously worldwide.

As someone involved in translation, by quickly and accurately translating documents that arise at each stage of the development, clinical trials, and approval of new drugs (from Japanese to English for Japanese pharmaceutical companies, and from English to Japanese for overseas companies), we can contribute to the world of healthcare.

In the field of medical devices, it is important to contribute to the prompt introduction of useful medical devices, regardless of whether they are imported from overseas or exported domestically.

Global product development and release on a worldwide scale is common in IT-related localization and consumer goods. However, when it comes to the rapid introduction of pharmaceuticals and medical devices that affect life and health, there seems to be a different level of importance.

3. Challenges and things to note in medical translation

If you have read about the abilities required for pharmaceutical translation and the importance of medical translation and pharmaceutical translation that we have introduced so far, I believe you understand the need for high language skills and specialized knowledge, as well as the importance of accuracy and promptness in medical translation.

Let's give an example of the difficulty and things to be careful about in medical translation below.

 

■In medical books and papers published by publishers, it is common to request supervision and editing by university professors and authoritative doctors in the relevant field as reviewers and editorial board members. Pharmaceutical companies and others often become sponsors as well.
Medical books and papers, which require precise translation, often have reviewers and editorial board members who have particularly high expectations for translation. In addition, the reviewers and editorial board members are usually extremely busy, so it is necessary for those involved in translation to ensure the highest possible quality before submitting it for their review. In the production process, pharmaceutical companies, as sponsors, are also involved in confirming the translation. In the case of pharmaceutical companies, they tend to be very careful about whether the effectiveness and safety of drugs mentioned in the content (regardless of whether they are their own products or those of competing companies) are accurately described.

 

■In the safety departments of pharmaceutical companies and CROs, it is necessary to promptly report information on adverse drug reactions, including the name, severity, and causality, to the authorities. The deadline for reporting to the authorities is determined based on the severity and causality of the event.
When reporting safety information, case reports using CIOMS and other formats are often considered relatively easy to understand, but they are still specialized documents with a high level of expertise. Additionally, during the progress of clinical trials, a large number of documents may be generated at once, requiring a high level of promptness.
Furthermore, reporting elements such as administration to pregnant women or infants, administration outside the specified indications, and administration exceeding the specified dosage are also crucial when reporting to the authorities. If there are translation errors that could affect the determination of these elements, it becomes a problem. Therefore, it is important for safety personnel in pharmaceutical companies and CROs to accurately translate to ensure that there are no incorrect judgments regarding severity and causality.

 

Here, let's take a look at the actual text of the clinical trial document.

 

 

If we were to translate the above sentence using machine translation, with the current state of machine translation, we would be able to create a translation at a certain level. Moreover, the immediate and large-scale creation of translations is a significant advantage.

However, if the text is of a certain length or longer, it is necessary to check the structure of the translated text to ensure there are no issues. It is also essential to confirm whether specialized terms that are frequently used in the text are translated correctly (whether they are expressed in a general manner, whether they are the most appropriate terms in the context, and whether there is consistency in the translation).

In addition, when translating by human hands, if the translator is excellent, they will consider and investigate what the investigational drug, which is the main focus of this sentence, is, what the purpose of the trial in the sentence is, and what impact the trial results have on the drug's clinical trial, in addition to the elements mentioned above.

However, machine translation does not make judgments like the one mentioned above, but rather performs analysis of the text and references the corpus. Therefore, it is necessary to carefully confirm the content mentioned above through the post-editing process.

The translation requester and translation company should consider these factors and appropriately determine whether to use machine translation or human translation, taking into account the required translation quality level, delivery date, and budget. It seems necessary to consider the progress of the translation project. Additionally, if there are many reused sections in existing documents due to reasons such as revisions, it becomes a viable option to use translation support tools such as Trados and utilize the existing translation as a translation memory when translating manually.

4. Points to consider when selecting a medical translation service provider

Here are some points to consider when selecting a medical translation service provider.

 

A company with highly skilled translators
Translating medical documents presents the same level of difficulty as mentioned in this column. As a fundamental requirement, it is necessary to be a translation company with a wealth of highly skilled and experienced translators in the pharmaceutical and medical fields.

 

A company with a translation department specializing in medical translation, with a track record in medical translation
A translation company with a track record in various domestic and international medical-related companies and medical institutions is definitely reassuring. It may be a good idea to check the track record on the translation company's website.

 

A company that can provide technology-enabled solutions
In medical translation, where a large amount of documents must be translated quickly, it is no longer difficult to exclude machine translation and translation support tools from the options from the beginning. In addition, new technologies such as videos and e-learning are emerging one after another. It can be said that a company that can provide a wide range of solutions, including machine translation and translation support tools, and can also handle new content, is desirable.

 

 

■Leave medical translation to Human Science
Human Science has accumulated a track record and expertise in translation support tools, machine translation, and checking tools, and has been involved in many translation and document creation projects. In the medical field, where specialized knowledge is required, Human Science provides fast and high-quality translations through the combination of human expertise and technology. Please take advantage of Human Science's services, which provide both high accuracy and speed as well as cost efficiency through technology and the assurance of work by excellent professionals.