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What is Medical and Pharmaceutical Translation? Skills Required for Translators and Points to Consider When Choosing a Translation Service

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2023.2.1

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2024.8.23

What is Medical and Pharmaceutical Translation? Skills Required for Translators and Points to Consider When Choosing a Translation Service


Table of Contents

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

At the introduction page of our medical and pharmaceutical translation services at Human Science, we divide the translation targets in the medical industry into "pharmaceutical and medical translation services" and "medical equipment 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 lot of attention due to the COVID-19 pandemic. In fact, PCR testing equipment, vaccine development, ECMO, and artificial respirators have all been hot topics. However, what is the actual market situation like? It seems to vary depending on whether it is the pharmaceutical industry or the medical equipment industry, and whether it is domestic or global. However, as a whole, the medical industry has a relatively stable demand and is less affected by economic conditions, and there also seems to be a stable demand for translation services.

 

In addition, the demand for translation of documents related to clinical trials is increasing every year in the medical field.
With the increase in international clinical trials and the need for multilingual support, accurate translation is essential.
Examples of documents that are subject to translation include the clinical trial protocol and the informed consent form, and accurate translation is crucial for the success of clinical trials.

 

The Difference Between Medical Translation and Other Types of Translation

There are several important differences between medical translation and other types of translation.

 

・Advanced and specialized knowledge is required
First of all, medical translation is characterized by the requirement of advanced and specialized knowledge. The medical field has many unique terms and abbreviations, and the ability to accurately understand and translate them is required. For example, drug names, disease names, treatment methods, and diagnostic names all require specialized knowledge, and mistranslations can have serious consequences on a patient's health.
Furthermore, medical knowledge is constantly updated, so in order to perform medical translation, it is necessary to constantly acquire the latest medical knowledge from conferences and research papers.
On the other hand, in general translation, specific specialized knowledge is not always required, and the ability to understand context and cultural background and replace them with appropriate expressions is emphasized. Of course, in other fields such as technical translation and legal document translation, specialized knowledge may also be required, but it is not as specialized as medical translation.

 

・Accuracy and consistency are required
In medical translation, accuracy and consistency are particularly important. Medical documents often have a legal aspect and mistranslations can lead to legal issues. Therefore, translators must always update their medical knowledge and maintain consistency in terminology. In contrast, general translation often requires flexibility in style and expression, and creative approaches may be allowed.

 

・Ethical Considerations are Necessary
In addition, ethical considerations are important in medical translation. Confidentiality to protect patient privacy and clear and concise expressions to avoid misunderstandings with patients are required. In contrast, in general translation, the confidentiality and ethical considerations of information are not always required at the same level.

 

In general, medical translation requires advanced expertise, accuracy, consistency, and ethical consideration, making it a highly specialized field that requires a different skill set and sense of responsibility compared to other translations.

 

Do you need qualifications for medical translation?

When it comes to qualifications in the medical field, you may first think of a doctor's or pharmacist's license, but it is not realistic for active professional translators or those aspiring to become professional translators to obtain these qualifications, especially a medical license. Therefore, as a way to demonstrate their translation skills, the JTF Translation Certification, which includes the field of medicine and pharmaceuticals, is introduced here. The 1st and 2nd levels are considered difficult with a pass rate of less than 5%, making it a public proof of one's translation skills in the medical field.

In addition to the JTF Translation Certification, there is also a qualification to prove medical translation ability.

・JTA Certified Translation Professional Qualification
・Japanese Medical English Proficiency Test (MedEiken)
・Clinical Trial English Proficiency Test
・Translation Practice Test TQE
・"Amelia" Regular Trial

Some examples include:

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.

 

Neurology Department, Cardiology Department, Respiratory Department, Gastroenterology Department, Obstetrics and Gynecology Department, Urology Department, Dermatology Department, Dentistry Department, Ophthalmology Department, Orthopedic Department, Surgery Department, Psychiatry Department, Endocrinology and Metabolism Department, Oncology Department, Anesthesia Department

 

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.

 

  • (English)Study aaaaaaa is a randomized study evaluating bbbbbbb monotherapy versus physician’s choice (ccccccc, ddddddd, or eeeeeee) for the treatment of mCRPC patients with a BRCA1/2 or ATM mutation who have received prior treatment with AR-directed therapy but have not yet received fffffff chemotherapy in the castration-resistant setting.
  • (Translation) This is a randomized trial to evaluate the efficacy of this drug as monotherapy and the selected other drugs (ccccccc, ddddddd, or eeeeeee) in mCRPC patients with BRCA1/2 mutations or ATM mutations who have a history of androgen receptor (AR)-targeted therapy but have not received chemotherapy treatment.

 

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.

5. Introduction of Medical Translation Case Studies

Full review system by 150 medical and pharmaceutical translators and specialized reviewers

At Human Science, we believe that one of the important factors that affects the quality of translation is the review (check) process after the translation work. Therefore, we have a system in place where experienced specialists review the entire translation.
This process helps to detect and correct any errors or mistakes made by the translator during the translation stage. In addition, it improves the accuracy of the translation from a professional perspective and contributes to stabilizing the overall translation quality by coordinating translations from multiple translators.

 

Medical and Pharmaceutical Translator

We have 150 translators with experience in the medical and clinical trial fields. We offer native M.D (Doctor of Medicine) and Ph.D (Doctor of Philosophy) check and English proofreading services.

Japanese-English Translator
Japanese-English Translator
Ph.D

Areas of Expertise
Bio, Genetics, Computational Chemistry
Achievements
Oncology (Protocol), Gynecology (ICF), Cell Biology (Paper)

Japanese-English Translator
Japanese-English Translator
26 years of experience in medical translation. 15 years of experience working at a medical translation company.

Areas of Expertise
Oncology
Achievements
Lung Cancer (CSR), Colorectal Cancer (IB), PMDA Inquiry Items, Clinical Trial Implementation Plan, Clinical Trial Summary Report, Case Report, Informed Consent Document, Investigational Drug Summary, PMS, Inquiry Items

Japanese-English Translator
Japanese-English Translator
25 years of experience in medical translation

Areas of Expertise
Regenerative Medicine (iPS Cells)
Achievements
Cardiovascular field (paper), leukemia (paper), respiratory field (treatment guidelines)

English to Japanese Translator
English-Japanese Translator
12 years of experience in medical translation

Areas of Expertise
Diabetes, Hemophilia Studies
Achievements
Colorectal cancer (paper), breast cancer (summary report), diabetes (paper)

English to Japanese Translator
English-Japanese Translator
10 years working at a pharmaceutical research institute

Areas of Expertise
Oncology, CMC
Achievements
Biopharmaceuticals (CTD2.3), Oncology (Review Report), CMC

English to Japanese Translator
English to Japanese Translator
Pharmacist

Areas of Expertise
Cardiology, Oncology
Achievements
Urinary tract epithelial cancer (protocol), antibody medicine (CTD 2.3), inferior vena cava filter (CSR)

English to Japanese Translator
English to Japanese
24 years of translation experience
10 years working at a medical translation company

Areas of Expertise
Clinical, Non-clinical, Post-marketing Surveillance
Achievements
Clinical trial implementation plan, clinical trial summary report, investigational drug summary, informed consent document, toxicity test, pharmacokinetic test, PMDA inquiry items, package insert

English to Japanese Translator
English to Japanese
24 years of translation experience
10 years working at a medical translation company

Areas of Expertise
Clinical, Non-clinical, Post-marketing Surveillance
Achievements
Clinical trial implementation plan, clinical trial summary report, investigational drug summary, informed consent document, toxicity test, pharmacokinetic test, PMDA inquiry items, package insert

English Proofreading
14 years of proofreading experience
8 years of research experience at overseas and national universities

Areas of Expertise
Clinical, Non-clinical, Post-marketing Surveillance
Achievements
Description Consent Document, Case Report, Clinical Trial Implementation Plan, SOP, Manuscript for Submission, Various Diagnostic Guidelines

Japanese-English Translator
Japanese-English
Translation Experience: 5 years
Research Experience: 4 years

Areas of Expertise
Clinical, Non-clinical
Achievements
Case report, clinical trial implementation plan, informed consent document, investigational drug summary, conference materials, medical literature, academic paper

English Proofreading/Doctor Proofreading
4 years of proofreading experience
PMDA Advisor, National Research Institute Clinical Fellow, Medical License Holder

Areas of Expertise
Clinical, Non-clinical, Post-marketing Surveillance
Achievements
Ministry of Health, Labour and Welfare notification, PMDA inquiry matters, safety reports, papers for submission, various diagnostic guidelines, press releases, various internal materials

 

Medical Device Translator

To provide high-quality translation, translators with prior knowledge of diagnostic and treatment procedures using specific medical devices will be in charge of the translation.

15 years of translation experience
15 years of experience working for a domestic medical device manufacturer

Medical equipment

Academic papers, clinical trial implementation plans, test equipment overview documents, clinical trial summary reports, technical reports, user manuals, defect reports, administrative agency submission documents

Translation Experience: 3 years
Foreign Pharmaceutical Company
Work Experience: 11 years

Pharmaceuticals, Medical Devices

Instruction manuals, software-related materials, attachments, clinical trial drug summary, clinical trial implementation plan, exhibition/conference reports, academic papers

Translation Experience: 13 years
Worked at a domestic pharmaceutical company
for 8 years

Pharmaceuticals, Medical Devices

Clinical trial implementation plan, investigational drug summary, clinical trial summary report, informed consent document, letter to the clinical trial responsible physician, drug package insert, adverse event report

 

Hiring translators and post-editors who meet the quality standard of a 20% pass rate.

"Human Science has 150 translators and 75 post-editors on staff, and we conduct selection and trial screenings for specialized translators and post-editors in the industry.
Only contracted translators and post-editors who have been evaluated by native translation directors and their track record are assigned to projects.
We have strict criteria, with a pass rate of 20% for translators and 10% for post-editors.
With an average experience of over 5 years, we guarantee quality and peace of mind."

 

 

Introducing some examples of medical translation

We have a track record of transactions with various companies, from pharmaceutical companies to medical device manufacturers.

Pharmaceutical Company
ASKA Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Co., Ltd.
Mitsubishi Tanabe Pharma Corporation
Chugai Pharmaceutical Co., Ltd.
Novartis Pharma K.K.
Ryukakusan Co., Ltd.
CRO
ICON plc, Japan
Quintiles Transnational Japan Co., Ltd.
Shin Nihon Kagaku PPD Co., Ltd.
Parexel International, Inc.
MediScience Planning Co., Ltd.
DOT World Co., Ltd.
Medical equipment
Array Co., Ltd.
Illumina Inc.
Carl Zeiss Meditec AG
Konica Minolta Corporation
Seed Co., Ltd.
NIDEK CO., LTD.
Nippon Kogei Kogyo Co., Ltd.
Becton, Dickinson and Company Japan
Medtronic Japan Co., Ltd.
Baxter Corporation
FUJIFILM Medical Co., Ltd.
Beckman Coulter, Inc.
Boston Scientific Japan Co., Ltd
Lion Co., Ltd.
Life Science Analysis Equipment
Illumina Inc.
Sartorius Japan Co., Ltd.
Cosmic Corporation Co., Ltd.
Thermo Fisher Scientific Inc.
THERMO FISHER DIAGNOSTICS CO., LTD.
Japan Waters Co., Ltd.
Japan Analytical Instruments Manufacturers' Association
Life Technologies Japan Co., Ltd.
Levity Japan Co., Ltd.
STEMCELL Technologies
Japan Tissue Engineering Co., Ltd.
Others
The Japanese Respiratory Society
The Japanese Society of Allergology
National Center of Neurology and Psychiatry, National Institute of Mental Health
Medical Review Co., Ltd.
Jihou Co., Ltd.
Crecon Research & Consulting Co., Ltd.
ENSYS CO.,LTD.
TARGIS CO.,LTD.
Carenet Co., Ltd.
ArisGlobal

 

 

■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.

 

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