Medical Translation – An Overview
Linguistic and domain expertise are paramount in medical translation since errors ultimately have the potential to jeopardise patient health. EIYAKU’s client list is testament to our excellence in the field, and includes the top 3 Contract Research Organisations, handling around 25% of all Clinical Trials conducted in the world today.
EIYAKU is well-versed in PMDA processes, applications and document types, meaning we’re able to handle all texts relating to regulatory approvals in Japan.
Our workflow is ever mindful of the following:
1. Precision and Accuracy Are Paramount
Medical translation involves life-critical information — drug dosages, clinical procedures, or patient safety data. Even a small mistranslation can cause medical errors or legal repercussions. Translators must ensure absolute terminological accuracy, often referencing standard medical databases like MedDRA, SNOMED CT, or ICD.
2. Understanding of Specialised Terminology
Medical language is highly technical. Terms may vary between specialties (oncology vs. cardiology) or between regions (e.g., US vs. EU regulatory language). Translators should possess deep domain knowledge and stay updated on medical terminology trends and clinical research terminology.
3. Compliance with Regulatory Standards
Different countries enforce specific requirements for medical documents:
- PDMA (Japan), FDA (U.S.) and EMA (EU) have strict translation regulations for clinical trials and pharmaceutical documentation.
- Translators must be aware of ICH-GCP, ISO 17100, and ISO 13485 guidelines.
Failure to comply can delay drug approvals or violate patient information laws.
4. Cultural and Linguistic Sensitivity
Beyond terminology, cultural nuances matter — particularly in patient-facing materials such as informed consent forms or instructions for use (IFUs). A translation that sounds overly technical or insensitive can confuse or alienate patients. The goal is clarity and empathy while maintaining professional precision.
5. Confidentiality and Data Protection
Medical translations often involve sensitive patient data and proprietary research. Translators must follow strict confidentiality protocols and comply with data privacy regulations like HIPAA (U.S.) and GDPR (EU). Secure data handling and non-disclosure agreements are essential.
6. Collaboration with Subject Matter Experts
Medical translators frequently collaborate with doctors, pharmacists, or clinical researchers to ensure accuracy. Peer reviews and quality checks (including back translation) are common steps to verify fidelity.
7. Technology and Translation Tools
Computer-assisted translation (CAT) tools and terminology management systems improve consistency and speed. However, machine translation alone is unsafe for medical contexts — post-editing by qualified medical linguists remains essential.
8. Continuous Training and Certification
Professional development is key. Reputable translators often hold certifications such as ATA Medical Translation, IMIA Medical Interpreter Certification, or equivalent. Continuing education helps maintain accuracy as medical science evolves.
EIYAKU works with the world’s leading pharmaceutical and medical device manufacturers.
With meticulous attention to detail and a commitment to excellence, we deliver medical translations that our clients can rely on for regulatory applications, clinical research and patient data.
EIYAKU is not confined to the past—we are passionate about working with the cutting edge technologies shaping our world today.
EIYAKU aspires to bridge JA > EN linguistic boundaries, ushering in a new era of medical research that leaves an indelible mark on the public health landscape.
Our comprehensive suite of professional services caters to a diverse clientele, ranging from clinical researchers to medical device manufacturers. With a commitment to innovation and efficiency, EIYAKU is the bridge that translates medical science into real-world solutions.
EIYAKU benefits from consultancy from medical doctors and researchers.
We’ve worked with some of the best companies.
