Pharmaceutical Products
Translation of pharmaceutical products is one of the most challenging aspects of medical translation because a single mistake in dosage can lead to severe consequences. Translation of prescription drug labels and information into the native language of users is required to ensure that they fully understand the uses, interaction of the drug with other drugs and foods, and when and how the drugs should be taken. Disease names are expressed using long unique names in Japanese, while acronyms or abbreviations are used in English. Completely different names are used in Japanese even for diseases such as AIDS or SARS. This type of naming convention is also followed for pharmaceutical products. Knowledge and experience are required to translate information on the ingredients of drugs and to fill in the application forms.
For over 10 years, I have applied my background in molecular biology to focus on medical translation including academic research papers, clinical trial reports, case reports, investigator’s brochures, informed consent forms, and standard operating procedure documents. I also have many years of experience with pharmaceutical translation including interview guides, marketing materials, regulatory documents, and CMC (chemistry, manufacturing, and controls) requirements. The fact that my work directly impacts the lives of patients is always at the front of my mind, and each project is approached with the careful dedication that it deserves.
The market size of the pharmaceutical industry in Japan is said to be about seven trillion yen (70 billion dollars). The market is divided into medical, general and deployment. The pharmaceutical industry has been undergoing a significant transformation in recent years. 1) Pharmaceutical companies are merging in Japan and across the globe, 2) New drugs are being launched, and 3) Participation of foreign companies in Japan is intensifying, and there is a spread of generic drugs. The pharmaceutical industry environment will continue to change in the future, with enhancements to the Medical Care System for the Elderly and amendments to the Pharmaceutical Affairs Law. Since more time is required to complete the procedures for medical devices in Japan than in other countries, devices used to provide treatment in other countries are not yet available in Japan. While the government and applicants continue to search for ways to eliminate the lag in using the devices, I look forward to supporting customers working on regulatory submissions and clinical trials required to be completed within a limited time frame with “precise, unambiguous translation that is easy for the readers to understand”.
Medical Devices
Documentation of medical devices is increasing in translation localization, and translation processes are being actively carried out using support tools such as SDL Trados. I have translated manuals for medical devices such as artificial heart-lung machines, catheters and CT, and dictionaries of pharmaceutical and medical terms.
The contents have to be translated accurately and with high quality for the development and sales of medical devices. In Japan, translation of large volumes of documents such as reports of the safety tests conducted overseas, manuals, package inserts and application forms for manufacturing and marketing approval is required to manufacture and sell devices such as pacemakers and catheters, which have been developed and manufactured overseas. Users have to appropriately understand the purpose, operations, how to assemble and use the devices. I translate manuals of devices so that the target users can understand the contents.
Although developed nations, including Japan, are well-known for population aging, the problem is progressing rapidly even in developing nations. The aging rate for developing nations is forecast to reach 16.8% in 2060, according to a survey and estimation by the Ministry of Internal Affairs and Communications and the National Institute of Population and Social Security Research. Therefore, to extend healthy life expectancy and realize a society with well-equipped medical and welfare services that will enable the elderly to lead a healthy life is a challenge for Japan and across the globe.
With this background, the medical device industry is becoming more active around the globe. For example, English manuals of pulse oximeters and catheters imported from America are translated into Japanese. At the same time, Japanese manuals of artificial heart-lung machines exported from Japan to different countries are translated into multiple languages. The current situation is that the latest medical devices are moving across international borders as health care is a global problem and not just faced by developed nations such as Japan. This is because of more demand for medical devices with the increase in users of medical services in an aging society. For manufacturing and selling medical devices developed outside Japan, translation of large volumes of documents such as reports of the safety tests conducted overseas, manuals, package inserts and application forms submitted for manufacturing and marketing approval is required. If the application form for approval is mistranslated or difficult to understand, the reviewers will be confused and take more time to review the application. I provide “accurate and easy to read translations while maintaining consistency between documents”, contributing to the quick use of medical devices at clinical sites.