{"id":13744,"date":"2026-03-19T12:50:16","date_gmt":"2026-03-19T12:50:16","guid":{"rendered":"https:\/\/www.1stopasia.com\/blog\/?p=13744"},"modified":"2026-03-31T09:40:21","modified_gmt":"2026-03-31T09:40:21","slug":"medical-japanese-orange-book","status":"publish","type":"post","link":"https:\/\/www.1stopasia.com\/blog\/medical-japanese-orange-book\/","title":{"rendered":"1-StopAsia Orange Book Series: Japanese Medical Translation"},"content":{"rendered":"

AI Overview<\/h2>\n
\n\n\n\n\n\n\n\n\n
Category<\/strong><\/td>\nSummary<\/strong><\/td>\n<\/tr>\n
Topic<\/strong><\/td>\nJapanese Medical Localization Quality Standards<\/td>\n<\/tr>\n
Purpose<\/strong><\/td>\nA practitioner guide for translators, reviewers, and QA leads working on Japanese medical content. Defines quality standards applicable when no client style guide is provided.<\/td>\n<\/tr>\n
Key Insight<\/strong><\/td>\nJapanese medical content requires three quality layers that generic frameworks miss: regulatory register calibration, domain-specific honorific conventions, and controlled katakana standardization for foreign medical terms.<\/td>\n<\/tr>\n
Best Use Case<\/strong><\/td>\nPharmaceutical labeling, IFUs, clinical protocols, patient-facing materials, medical device documentation \u2014 in the absence of client-defined quality criteria.<\/td>\n<\/tr>\n
Risk Warning<\/strong><\/td>\nApplying general Japanese language rules to medical content without domain adaptation creates compliance risk and erodes credibility with Japanese medical professionals, even when the translation is linguistically accurate.<\/td>\n<\/tr>\n
Pro Tip<\/strong><\/td>\nRegulatory register (\u898f\u5236\u6587\u4f53) is non-negotiable in submission documents. Confirm document type before assigning register level \u2014 IFU \u2260 patient leaflet \u2260 clinical protocol.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n
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Download Article<\/a><\/div>\n
<\/div>\n<\/div>\n

1. Introduction<\/h2>\n

This guide is part of the 1-StopAsia Orange Book Series. It documents the quality standards applied by our Japanese linguistic and medical QA teams when working on medical content for which no client-defined style guide exists.<\/p>\n

Medical Japanese occupies a distinct register that differs from both general business Japanese and technical Japanese. A translator with native Japanese fluency and general domain expertise will still produce substandard medical content without explicit training in the conventions documented here.<\/p>\n

This document is organized into five sections:<\/p>\n

    \n
  • Regulatory Register: the mandatory style conventions for different medical document types<\/li>\n
  • Honorific and Person Reference: how to refer to patients, physicians, and institutions correctly by document type<\/li>\n
  • Katakana Standardization: the 1-StopAsia standard for foreign medical terminology rendered in katakana<\/li>\n
  • Medical Terminology Conventions: specific rules for high-frequency terms that cause consistent errors<\/li>\n
  • Punctuation, Format, and Numbers: Japanese-specific formatting rules for medical content<\/li>\n<\/ul>\n
    \n\u26a0 Clinical Note:<\/strong><\/span> This guide applies when no client instruction, TM, glossary, or style guide is available. When client materials exist, those always take precedence. Questions must be raised with the PM before the project begins \u2014 not after delivery.\n<\/div>\n

    2. Regulatory Register (\u898f\u5236\u6587\u4f53)<\/h3>\n

    The single most common quality failure in Japanese medical localization is applying the wrong register to a document type. Japanese medical documents are not all written in the same style. Each document type has a defined register that Japanese regulatory professionals and medical practitioners expect and deviation is not a stylistic choice, it is an error.<\/p>\n

    2.1 Document Type Register Matrix<\/h3>\n

    Apply the following register classification before beginning any translation:<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n
    Document Type<\/strong><\/th>\nRegister<\/strong><\/th>\nForm (\u6587\u4f53)<\/strong><\/th>\nNotes<\/strong><\/th>\n<\/tr>\n<\/thead>\n
    Regulatory submission (CTD, PMDA)<\/td>\nFormal regulatory (\u898f\u5236\u8a9e)<\/td>\n\u3067\u3042\u308b\u8abf (Da-aru)<\/td>\nNon-negotiable. No deviations.<\/td>\n<\/tr>\n
    Instructions for Use (IFU \/ \u53d6\u6271\u8aac\u660e\u66f8)<\/td>\nTechnical formal<\/td>\n\u307e\u3059\u8abf (Masu) or mixed<\/td>\nImperative constructions are common.<\/td>\n<\/tr>\n
    Clinical trial protocol<\/td>\nFormal academic (\u5b66\u8853\u8a9e)<\/td>\n\u3067\u3042\u308b\u8abf<\/td>\nPassive voice preferred in procedures.<\/td>\n<\/tr>\n
    Package insert (\u6dfb\u4ed8\u6587\u66f8)<\/td>\nFormal regulatory<\/td>\n\u3067\u3042\u308b\u8abf<\/td>\nPMDA template language must be followed.<\/td>\n<\/tr>\n
    Patient-facing leaflet<\/td>\nPolite accessible (\u4e01\u5be7\u8a9e)<\/td>\n\u307e\u3059\u8abf<\/td>\nAvoid technical jargon. Plain language.<\/td>\n<\/tr>\n
    Medical device manual<\/td>\nTechnical polite<\/td>\n\u307e\u3059\u8abf<\/td>\nInstructional imperative for procedures.<\/td>\n<\/tr>\n
    Healthcare professional communication<\/td>\nProfessional polite (\u656c\u8a9e)<\/td>\n\u307e\u3059\u8abf + keigo<\/td>\nSee Section 3 for honorific detail.<\/td>\n<\/tr>\n
    Adverse event \/ complaint report<\/td>\nFormal regulatory<\/td>\n\u3067\u3042\u308b\u8abf<\/td>\nFactual, passive, no evaluative language.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
    \n\u26a0 Clinical Note:<\/strong><\/span> Never apply \u307e\u3059\u8abf (masu-form) to PMDA regulatory submissions or CTD documents. PMDA reviewers expect \u3067\u3042\u308b\u8abf throughout. This is not a preference \u2014 it is a regulatory convention that affects perceived document credibility.\n<\/div>\n

    2.2 Register Rules \u2014 Regulatory Documents<\/h3>\n

    [MR001]\u00a0Active vs. Passive Voice in Regulatory Submissions<\/strong><\/p>\n

    In regulatory submissions, procedures and findings are described in the passive voice. Active construction is standard in English medical writing but reads as inappropriate in Japanese regulatory context.<\/p>\n\n\n\n\n\n\n
    Source (English)<\/strong><\/th>\n\u2717 Incorrect<\/strong><\/th>\n\u2713 Correct<\/strong><\/th>\nRationale<\/strong><\/th>\n<\/tr>\n<\/thead>\n
    We administered the drug at 10mg\/kg.<\/td>\n\u79c1\u305f\u3061\u306f\u85ac\u5264\u309210mg\/kg\u3067\u6295\u4e0e\u3057\u305f\u3002<\/span><\/td>\n\u85ac\u5264\u309210mg\/kg\u3067\u6295\u4e0e\u3057\u305f\u3002\/ \u85ac\u5264\u306f10mg\/kg\u3067\u6295\u4e0e\u3055\u308c\u305f\u3002<\/span><\/td>\nSubject ‘we’ dropped. Passive preferred in procedural description.<\/td>\n<\/tr>\n
    The investigator assessed the response.<\/td>\n\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u304c\u53cd\u5fdc\u3092\u8a55\u4fa1\u3057\u305f\u3002<\/span><\/td>\n\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u306b\u3088\u308a\u53cd\u5fdc\u304c\u8a55\u4fa1\u3055\u308c\u305f\u3002<\/span><\/td>\nPassive construction aligns with PMDA document conventions.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

    [MR002] Non-Assertive Language in Safety Sections<\/strong><\/p>\n

    Safety sections in package inserts and IFUs must use non-assertive language conventions (\u975e\u65ad\u5b9a\u8868\u73fe). Absolute statements are avoided unless supported by clinical data in the source.<\/p>\n\n\n\n\n\n\n
    Source (English)<\/strong><\/th>\n\u2717 Incorrect<\/strong><\/th>\n\u2713 Correct<\/strong><\/th>\nRationale<\/strong><\/th>\n<\/tr>\n<\/thead>\n
    This drug causes liver damage.<\/td>\n\u3053\u306e\u85ac\u5264\u306f\u809d\u81d3\u969c\u5bb3\u3092\u5f15\u304d\u8d77\u3053\u3059\u3002<\/span><\/td>\n\u3053\u306e\u85ac\u5264\u306f\u809d\u81d3\u969c\u5bb3\u3092\u5f15\u304d\u8d77\u3053\u3059\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002\/ \u809d\u6a5f\u80fd\u969c\u5bb3\u304c\u3042\u3089\u308f\u308c\u308b\u3053\u3068\u304c\u3042\u308b\u3002<\/span><\/td>\nAbsolute causation language avoided without clinical data qualifier.<\/td>\n<\/tr>\n
    Do not use in patients with renal impairment.<\/td>\n\u814e\u6a5f\u80fd\u969c\u5bb3\u306e\u3042\u308b\u60a3\u8005\u306b\u306f\u4f7f\u7528\u3059\u308b\u3002<\/span><\/td>\n\u814e\u6a5f\u80fd\u969c\u5bb3\u306e\u3042\u308b\u60a3\u8005\u306b\u306f\u4f7f\u7528\u3057\u306a\u3044\u3053\u3068\u3002<\/span><\/td>\n‘\u3053\u3068’ construction for prohibitions in regulatory documents.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

    [MR003]\u00a0Prohibition and Instruction Constructions<\/strong><\/p>\n

    Japanese medical regulatory documents use specific grammatical constructions for prohibitions, instructions, and warnings. These constructions are fixed \u2014 variation is not appropriate.<\/p>\n\n\n\n\n\n\n\n\n
    Intent<\/strong><\/th>\nConstruction<\/strong><\/th>\nExample<\/strong><\/th>\nDocument context<\/strong><\/th>\n<\/tr>\n<\/thead>\n
    Prohibition<\/td>\n\u301c\u306a\u3044\u3053\u3068 \/ \u301c\u3057\u3066\u306f\u306a\u3089\u306a\u3044<\/td>\n\u76f4\u5c04\u65e5\u5149\u3092\u907f\u3051\u308b\u3053\u3068<\/td>\nIFU, package insert<\/td>\n<\/tr>\n
    Instruction<\/td>\n\u301c\u3059\u308b\u3053\u3068 \/ \u301c\u3057\u3066\u304f\u3060\u3055\u3044<\/td>\n\u51b7\u6240\u4fdd\u5b58\u3059\u308b\u3053\u3068<\/td>\nIFU formal \/ patient leaflet<\/td>\n<\/tr>\n
    Warning<\/td>\n\u301c\u306e\u304a\u305d\u308c\u304c\u3042\u308b \/ \u301c\u306b\u6ce8\u610f\u3059\u308b\u3053\u3068<\/td>\n\u904e\u91cf\u6295\u4e0e\u306e\u304a\u305d\u308c\u304c\u3042\u308b<\/td>\nPackage insert, warnings section<\/td>\n<\/tr>\n
    Contraindication<\/td>\n\u301c\u60a3\u8005\u306b\u306f\u6295\u4e0e\u3057\u306a\u3044\u3053\u3068<\/td>\n\u672c\u5264\u306b\u904e\u654f\u75c7\u306e\u60a3\u8005\u306b\u306f\u6295\u4e0e\u3057\u306a\u3044\u3053\u3068<\/td>\nPackage insert, contraindications<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

    3. Honorifics and Person Reference<\/h2>\n

    Person reference in Japanese medical content is not a stylistic decision. The way patients, physicians, and institutions are referred to is determined by document type, intended audience, and the relationship implied by the content. Errors here are visible to any Japanese medical professional even when the underlying translation is otherwise accurate.<\/p>\n

    3.1 Patient Reference<\/h3>\n

    [HP001] Patient Reference by Document Type<\/strong><\/p>\n

    The term used to refer to the patient varies by document type. Using the wrong patient reference term is a reliable indicator of non-specialist translation.<\/p>\n\n\n\n\n\n\n\n\n\n
    Document Type<\/strong><\/th>\n\u2717 Avoid<\/strong><\/th>\n\u2713 Correct term<\/strong><\/th>\nRationale<\/strong><\/th>\n<\/tr>\n<\/thead>\n
    Regulatory submission (CTD)<\/td>\n\u60a3\u8005\u3055\u3093<\/span><\/td>\n\u60a3\u8005<\/span><\/td>\n\u3055\u3093 suffix is inappropriate in formal regulatory\/academic context.<\/td>\n<\/tr>\n
    Package insert (\u6dfb\u4ed8\u6587\u66f8)<\/td>\n\u60a3\u8005\u3055\u3093<\/span><\/td>\n\u60a3\u8005<\/span><\/td>\nPackage inserts follow regulatory language convention.<\/td>\n<\/tr>\n
    Patient-facing leaflet<\/td>\n\u60a3\u8005<\/span><\/td>\n\u60a3\u8005\u3055\u3093 \/ \u7686\u69d8<\/span><\/td>\nDirect patient communication requires polite form. \u60a3\u8005 alone reads as clinical\/cold.<\/td>\n<\/tr>\n
    HCP communication (physician letter)<\/td>\n\u60a3\u8005\u3055\u3093<\/span><\/td>\n\u60a3\u8005<\/span><\/td>\nPhysician-to-physician register uses clinical term without honorific.<\/td>\n<\/tr>\n
    Informed consent form<\/td>\n\u60a3\u8005<\/span><\/td>\n\u60a3\u8005\u3055\u3093 \/ \u3042\u306a\u305f<\/span><\/td>\nConsent forms address the patient directly. Polite form required.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

    [HP002] Second Person Reference (YOU)<\/strong><\/p>\n

    English medical content uses ‘you’ extensively. Japanese medical documents handle second-person reference differently by document type. Do not translate ‘you’ mechanically.<\/p>\n\n\n\n\n\n\n
    Source (English)<\/strong><\/th>\n\u2717 Incorrect<\/strong><\/th>\n\u2713 Correct<\/strong><\/th>\nRationale<\/strong><\/th>\n<\/tr>\n<\/thead>\n
    If you experience side effects, contact your physician.<\/td>\n\u3042\u306a\u305f\u304c\u526f\u4f5c\u7528\u3092\u7d4c\u9a13\u3057\u305f\u5834\u5408\u3001\u3042\u306a\u305f\u306e\u533b\u5e2b\u306b\u9023\u7d61\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/span><\/td>\n\u526f\u4f5c\u7528\u304c\u73fe\u308c\u305f\u5834\u5408\u306f\u3001\u62c5\u5f53\u533b\u5e2b\u306b\u3054\u76f8\u8ac7\u304f\u3060\u3055\u3044\u3002<\/span><\/td>\n\u3042\u306a\u305f dropped. Passive construction and \u3054\u301c\u304f\u3060\u3055\u3044 honorific applied for patient-facing content.<\/td>\n<\/tr>\n
    You should not drive after taking this medication.<\/td>\n\u3042\u306a\u305f\u306f\u3053\u306e\u85ac\u3092\u98f2\u3093\u3060\u5f8c\u306b\u904b\u8ee2\u3057\u3066\u306f\u3044\u3051\u307e\u305b\u3093\u3002<\/span><\/td>\n\u672c\u5264\u670d\u7528\u5f8c\u306f\u81ea\u52d5\u8eca\u306e\u904b\u8ee2\u3092\u907f\u3051\u308b\u3053\u3068\u3002<\/span><\/td>\nRegulatory instruction construction for IFU context. No personal pronoun.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

    3.2 Physician and Institutional Reference<\/h3>\n

    \"1-StopAsia[HP003] Physician Reference<\/strong><\/p>\n

    How physicians are referenced depends on whether the document is addressed to them, about them, or for patients reading about them.<\/p>\n\n\n\n\n\n\n\n\n
    Context<\/strong><\/th>\nCorrect reference<\/strong><\/th>\nNotes<\/strong><\/th>\n<\/tr>\n<\/thead>\n
    Regulatory document (clinical)<\/td>\n\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b \/ \u6cbb\u9a13\u62c5\u5f53\u533b\u5e2b<\/td>\nSpecific titles required by PMDA. Do not substitute with \u533b\u5e2b alone.<\/td>\n<\/tr>\n
    Package insert instruction to prescriber<\/td>\n\u533b\u5e2b<\/td>\nGeneral physician reference in prescriber instructions.<\/td>\n<\/tr>\n
    Patient leaflet \u2014 referring to physician<\/td>\n\u62c5\u5f53\u306e\u533b\u5e2b \/ \u4e3b\u6cbb\u533b<\/td>\n\u60a3\u8005 audience requires accessible, humanized physician reference.<\/td>\n<\/tr>\n
    HCP letter \u2014 addressing physician directly<\/td>\n\u5148\u751f (in greeting only)<\/td>\n\u5148\u751f used in salutation. Body text uses \u533b\u5e2b or role title.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

    4. Katakana Standardization for Medical Terms<\/h2>\n

    Foreign medical terminology in Japanese is rendered in katakana. Unlike general consumer content where katakana variants are tolerated, medical katakana has established conventions in regulatory and clinical use. Variance from established medical katakana signals non-specialist translation immediately to Japanese medical professionals and regulatory reviewers.<\/p>\n

    The 1-StopAsia standard applies the following hierarchy when selecting katakana renderings for medical terms:<\/p>\n

      \n
    1. PMDA-approved term in existing Japanese labeling (highest authority)<\/li>\n
    2. Japanese Pharmacopoeia (\u65e5\u672c\u85ac\u5c40\u65b9) for pharmaceutical substances<\/li>\n
    3. Japan Society term conventions for disease names and procedures<\/li>\n
    4. High-frequency search result convention (established medical usage)<\/li>\n
    5. JIS standard for general katakana elongation rules (baseline only)<\/li>\n<\/ol>\n
      \n\u26a0 Clinical Note:<\/strong><\/span> Never select a katakana rendering based on general JIS elongation rules alone for medical terms. General rules produce technically correct but medically non-standard renderings. Always verify against established medical use.\n<\/div>\n

      4.1 Pharmaceutical Substance Names<\/h3>\n

      [KT001] INN (International Nonproprietary Names) in Katakana<\/strong><\/p>\n

      Drug substance names (INNs) have established Japanese katakana equivalents. Do not create new renderings from phonetic rules \u2014 use the established term.<\/p>\n\n\n\n\n\n\n\n\n
      Source (English)<\/strong><\/th>\n\u2717 Incorrect<\/strong><\/th>\n\u2713 Correct<\/strong><\/th>\nRationale<\/strong><\/th>\n<\/tr>\n<\/thead>\n
      Metformin<\/td>\n\u30e1\u30c8\u30d5\u30a9\u30eb\u30df\u30f3 (phonetic)<\/span><\/td>\n\u30e1\u30c8\u30db\u30eb\u30df\u30f3<\/span><\/td>\nEstablished PMDA\/JP term. ‘fo’ rendered as ‘ho’ by convention.<\/td>\n<\/tr>\n
      Warfarin<\/td>\n\u30a6\u30a9\u30fc\u30d5\u30a1\u30ea\u30f3<\/span><\/td>\n\u30ef\u30eb\u30d5\u30a1\u30ea\u30f3<\/span><\/td>\nJapanese Pharmacopoeia standard. Do not apply general katakana phonetics.<\/td>\n<\/tr>\n
      Adrenaline<\/td>\n\u30a2\u30c9\u30ec\u30ca\u30e9\u30a4\u30f3<\/span><\/td>\n\u30a2\u30c9\u30ec\u30ca\u30ea\u30f3<\/span><\/td>\nJP established term. Elongation applied differently than general rule.<\/td>\n<\/tr>\n
      Acetaminophen<\/td>\n\u30a2\u30bb\u30bf\u30df\u30ce\u30d5\u30a7\u30f3<\/span><\/td>\n\u30a2\u30bb\u30c8\u30a2\u30df\u30ce\u30d5\u30a7\u30f3<\/span><\/td>\nPMDA preferred term. Additional syllable in medical convention.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

      4.2 Disease and Condition Names<\/h3>\n

      [KT002] Disease Name Katakana Conventions<\/strong><\/p>\n

      Disease names in Japanese have mixed conventions \u2014 some are written in kanji (\u6f22\u5b57), some in katakana, some in both. The choice is not arbitrary and is established by Japan Society convention and regulatory precedent.<\/p>\n\n\n\n\n\n\n\n\n
      Source (English)<\/strong><\/th>\n\u2717 Incorrect<\/strong><\/th>\n\u2713 Correct<\/strong><\/th>\nRationale<\/strong><\/th>\n<\/tr>\n<\/thead>\n
      Alzheimer’s disease<\/td>\n\u30a2\u30eb\u30c4\u30cf\u30a4\u30de\u30fc\u75c5 alone (in formal docs)<\/span><\/td>\n\u30a2\u30eb\u30c4\u30cf\u30a4\u30de\u30fc\u578b\u8a8d\u77e5\u75c7 (regulatory) \/ \u30a2\u30eb\u30c4\u30cf\u30a4\u30de\u30fc\u75c5 (general)<\/span><\/td>\nPMDA prefers specific diagnostic term in regulatory context.<\/td>\n<\/tr>\n
      Diabetes mellitus type 2<\/td>\n2\u578b\u7cd6\u5c3f\u75c5 only<\/span><\/td>\n2\u578b\u7cd6\u5c3f\u75c5\uff08T2DM\uff09<\/span><\/td>\nEnglish abbreviation added in clinical documents per regulatory convention.<\/td>\n<\/tr>\n
      Myocardial infarction<\/td>\n\u5fc3\u81d3\u767a\u4f5c (patient-facing OK)<\/span><\/td>\n\u5fc3\u7b4b\u6897\u585e (regulatory\/clinical)<\/span><\/td>\n\u5fc3\u81d3\u767a\u4f5c is colloquial \u2014 acceptable in patient leaflets, not in clinical\/regulatory docs.<\/td>\n<\/tr>\n
      Hypertension<\/td>\n\u30cf\u30a4\u30d1\u30fc\u30c6\u30f3\u30b7\u30e7\u30f3<\/span><\/td>\n\u9ad8\u8840\u5727\u75c7 \/ \u9ad8\u8840\u5727<\/span><\/td>\nKatakana avoided for disease names with established kanji equivalents.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

      4.3 Procedure and Device Terms<\/h3>\n

      [KT003] Surgical and Diagnostic Procedure Katakana<\/strong><\/p>\n

      Procedure names in Japanese regulatory and clinical content follow conventions established in Japanese medical education and PMDA submissions. The following represent high-frequency errors in non-specialist Japanese medical translation.<\/p>\n\n\n\n\n\n\n\n\n
      Source (English)<\/strong><\/th>\n\u2717 Incorrect<\/strong><\/th>\n\u2713 Correct<\/strong><\/th>\nRationale<\/strong><\/th>\n<\/tr>\n<\/thead>\n
      Magnetic Resonance Imaging (MRI)<\/td>\n\u30de\u30b0\u30cd\u30c6\u30a3\u30c3\u30af\u30ec\u30be\u30ca\u30f3\u30b9\u30a4\u30e1\u30fc\u30b8\u30f3\u30b0<\/span><\/td>\n\u78c1\u6c17\u5171\u9cf4\u753b\u50cf (MRI)<\/span><\/td>\nAcronym retained in parentheses. Japanese term preferred in clinical docs.<\/td>\n<\/tr>\n
      Computed Tomography (CT)<\/td>\n\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u65ad\u5c64\u64ae\u5f71<\/span><\/td>\n\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u30fc\u65ad\u5c64\u64ae\u5f71 (CT) \/ CT\u691c\u67fb<\/span><\/td>\nElongation on \u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u30fc in current medical usage. CT acronym retained.<\/td>\n<\/tr>\n
      Catheter<\/td>\n\u30ad\u30e3\u30bb\u30bf\u30fc<\/span><\/td>\n\u30ab\u30c6\u30fc\u30c6\u30eb<\/span><\/td>\nEstablished medical katakana. Phonetic rendering is incorrect.<\/td>\n<\/tr>\n
      Stent<\/td>\n\u30b9\u30c6\u30f3\u30c8 alone in IFU instructions<\/span><\/td>\n\u30b9\u30c6\u30f3\u30c8\u7559\u7f6e\u8853 (procedure) \/ \u30b9\u30c6\u30f3\u30c8 (device reference)<\/span><\/td>\nDistinguish device from procedure in regulatory context.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

      5. Medical Terminology Conventions<\/h2>\n

      This section documents high-frequency terminology errors in Japanese medical translation. These are not edge cases \u2014 they appear consistently across projects handled by non-specialist translators and represent the most common quality failures caught by 1-StopAsia medical QA review.<\/p>\n

      5.1 Adverse Event Terminology<\/h3>\n

      [TM001] Adverse Event vs. Adverse Drug Reaction<\/strong><\/p>\n

      These terms have distinct definitions in Japanese regulatory context and must not be used interchangeably.<\/p>\n\n\n\n\n\n\n\n\n
      English<\/strong><\/th>\nIncorrect<\/strong><\/th>\nCorrect<\/strong><\/th>\nDefinition distinction<\/strong><\/th>\n<\/tr>\n<\/thead>\n
      Adverse event (AE)<\/td>\n\u526f\u4f5c\u7528<\/span><\/td>\n\u6709\u5bb3\u4e8b\u8c61<\/span><\/td>\nAny untoward event, regardless of causality. Not equivalent to ADR.<\/td>\n<\/tr>\n
      Adverse drug reaction (ADR)<\/td>\n\u6709\u5bb3\u4e8b\u8c61<\/span><\/td>\n\u526f\u4f5c\u7528 \/ \u85ac\u7269\u6709\u5bb3\u53cd\u5fdc<\/span><\/td>\nCausally linked to drug. \u526f\u4f5c\u7528 is the established PMDA term.<\/td>\n<\/tr>\n
      Serious adverse event (SAE)<\/td>\n\u91cd\u5927\u306a\u526f\u4f5c\u7528<\/span><\/td>\n\u91cd\u7be4\u306a\u6709\u5bb3\u4e8b\u8c61<\/span><\/td>\n\u91cd\u7be4 (serious\/life-threatening) is the regulatory standard. \u91cd\u5927 means ‘important’ not ‘serious’.<\/td>\n<\/tr>\n
      Side effect<\/td>\n\u6709\u5bb3\u4e8b\u8c61<\/span><\/td>\n\u526f\u4f5c\u7528 (patient-facing) \/ \u6709\u5bb3\u53cd\u5fdc (clinical)<\/span><\/td>\nPatient leaflets use \u526f\u4f5c\u7528. Do not use \u6709\u5bb3\u4e8b\u8c61 in patient communication.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

      [TM002] Frequency Terms for Adverse Events<\/strong><\/p>\n

      Japanese package inserts use specific frequency descriptors defined by PMDA. These must be applied exactly. Do not translate frequency terms using general Japanese equivalents.<\/p>\n\n\n\n\n\n\n\n\n\n
      Frequency<\/strong><\/th>\nRate<\/strong><\/th>\nPMDA term (\u6dfb\u4ed8\u6587\u66f8)<\/strong><\/th>\nAvoid<\/strong><\/th>\n<\/tr>\n<\/thead>\n
      Very common<\/td>\n\u22651\/10<\/td>\n\u975e\u5e38\u306b\u591a\u3044 \/ \u983b\u5ea6\u4e0d\u660e\u306e\u5834\u5408\uff1a\u983b\u5ea6\u4e0d\u660e<\/td>\n\u3068\u3066\u3082\u591a\u3044\u3001\u975e\u5e38\u306b\u983b\u7e41<\/td>\n<\/tr>\n
      Common<\/td>\n\u22651\/100 to <1\/10<\/td>\n\u3014\u983b\u5ea6\u3015%<\/td>\n\u3088\u304f\u3042\u308b\u3001\u4e00\u822c\u7684\u306a<\/td>\n<\/tr>\n
      Uncommon<\/td>\n\u22651\/1000 to <1\/100<\/td>\n\u3014\u983b\u5ea6\u3015%<\/td>\n\u307e\u308c\u306a\u3001\u5c11\u306a\u3044<\/td>\n<\/tr>\n
      Rare<\/td>\n\u22651\/10,000 to <1\/1,000<\/td>\n\u3014\u983b\u5ea6\u3015%<\/td>\n\u7a00\u306a\u3001\u975e\u5e38\u306b\u307e\u308c<\/td>\n<\/tr>\n
      Unknown frequency<\/td>\nCannot estimate<\/td>\n\u983b\u5ea6\u4e0d\u660e<\/td>\n\u4e0d\u660e\u3001\u308f\u304b\u3089\u306a\u3044<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
      \n\u26a0 Clinical Note:<\/strong><\/span> PMDA package insert format requires frequency to be expressed as observed percentages from clinical trial data wherever available, not as frequency category labels. Use category labels only for post-marketing data or when trial data is unavailable. Confirm document type before applying.\n<\/div>\n

      5.2 Dosing and Administration Terminology<\/h3>\n

      [TM003] Route of Administration<\/strong><\/p>\n

      Administration route terms in Japanese regulatory documents are standardized. Non-standard renderings trigger queries from PMDA reviewers.<\/p>\n\n\n\n\n\n\n\n\n\n
      Source (English)<\/strong><\/th>\n\u2717 Incorrect<\/strong><\/th>\n\u2713 Correct<\/strong><\/th>\nRationale<\/strong><\/th>\n<\/tr>\n<\/thead>\n
      Oral administration<\/td>\n\u53e3\u304b\u3089\u306e\u6295\u4e0e \/ \u98f2\u307f\u85ac<\/span><\/td>\n\u7d4c\u53e3\u6295\u4e0e<\/span><\/td>\n\u7d4c\u53e3\u6295\u4e0e is the regulatory standard. Patient-facing documents may use ‘\u670d\u7528’ or ‘\u98f2\u3080’.<\/td>\n<\/tr>\n
      Intravenous injection<\/td>\n\u9759\u8108\u3078\u306e\u6ce8\u5c04<\/span><\/td>\n\u9759\u8108\u5185\u6ce8\u5c04 \/ \u9759\u6ce8<\/span><\/td>\nAbbreviation \u9759\u6ce8 acceptable in clinical shorthand. Full term in regulatory docs.<\/td>\n<\/tr>\n
      Subcutaneous injection<\/td>\n\u76ae\u4e0b\u3078\u306e\u6ce8\u5c04<\/span><\/td>\n\u76ae\u4e0b\u6ce8\u5c04 \/ \u76ae\u4e0b\u6295\u4e0e<\/span><\/td>\nBoth acceptable in regulatory. \u76ae\u4e0b\u6ce8 in shorthand.<\/td>\n<\/tr>\n
      Topical application<\/td>\n\u5c40\u6240\u7684\u306a\u4f7f\u7528<\/span><\/td>\n\u5c40\u6240\u6295\u4e0e \/ \u5916\u7528<\/span><\/td>\n\u5916\u7528 for dermatological products. \u5c40\u6240\u6295\u4e0e broader regulatory term.<\/td>\n<\/tr>\n
      Once daily<\/td>\n\u4e00\u65e5\u306b\u4e00\u56de \/ 1\u65e51\u56de\/\u65e5<\/span><\/td>\n1\u65e51\u56de<\/span><\/td>\nPMDA standard format. Kanji numerals not used in dosage instructions.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

      [TM004] Dosage Form Terminology<\/strong><\/p>\n

      Pharmaceutical dosage forms have established Japanese terms. Colloquial equivalents are not acceptable in regulatory or IFU documents.<\/p>\n\n\n\n\n\n\n\n\n
      Dosage form<\/strong><\/th>\nAvoid<\/strong><\/th>\nCorrect term<\/strong><\/th>\nNotes<\/strong><\/th>\n<\/tr>\n<\/thead>\n
      Tablet<\/td>\n\u30bf\u30d6\u30ec\u30c3\u30c8 (general)<\/td>\n\u9320\u5264 \/ \u9320<\/td>\n\u9320 abbreviation in dosing instructions. \u9320\u5264 in descriptions.<\/td>\n<\/tr>\n
      Injection<\/td>\n\u6ce8\u5c04\u85ac<\/td>\n\u6ce8\u5c04\u5264<\/td>\n\u6ce8\u5c04\u5264 is the regulatory standard dosage form term.<\/td>\n<\/tr>\n
      Ointment<\/td>\n\u30af\u30ea\u30fc\u30e0 (specific type)<\/td>\n\u8edf\u818f\u5264 (ointment) \/ \u30af\u30ea\u30fc\u30e0\u5264 (cream)<\/td>\nOintment and cream are distinct forms with different regulatory terms.<\/td>\n<\/tr>\n
      Oral solution<\/td>\n\u98f2\u307f\u85ac<\/td>\n\u7d4c\u53e3\u6db2\u5264 \/ \u5185\u670d\u6db2\u5264<\/td>\n\u98f2\u307f\u85ac is colloquial and patient-facing only.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

      6. Punctuation, Format, and Numbers in Medical Context<\/h2>\n

      Formatting rules from the general 1-StopAsia Japanese Orange Book apply as baseline. The following medical-specific rules take precedence where they differ.<\/p>\n

      6.1 Numbers and Units in Medical Documents<\/h3>\n

      [FM001] Numeric Format for Dosage and Measurements<\/strong><\/p>\n

      Japanese medical documents use Arabic numerals for all dosage quantities, measurements, and clinical values. Kanji numerals are not used in clinical or regulatory content.<\/p>\n\n\n\n\n\n\n\n\n
      Source (English)<\/strong><\/th>\n\u2717 Incorrect<\/strong><\/th>\n\u2713 Correct<\/strong><\/th>\nRationale<\/strong><\/th>\n<\/tr>\n<\/thead>\n
      10 milligrams<\/td>\n\u5341\u30df\u30ea\u30b0\u30e9\u30e0 \/ 10 mg\uff08space before unit\uff09<\/span><\/td>\n10mg\uff08no space\uff09<\/span><\/td>\nNo space between numeral and unit in Japanese medical regulatory format.<\/td>\n<\/tr>\n
      5.5 micrograms\/kg\/day<\/td>\n5.5 \u03bcg\uff0fkg\uff0f\u65e5<\/span><\/td>\n5.5\u03bcg\/kg\/\u65e5<\/span><\/td>\nSlash not fullwidth slash (\uff0f). Use standard forward slash (\/).<\/td>\n<\/tr>\n
      Once every two weeks<\/td>\n1\u56de\/ 2\u9031<\/span><\/td>\n2\u9031\u9593\u306b1\u56de<\/span><\/td>\nFrequency expressed as interval then count in Japanese regulatory convention.<\/td>\n<\/tr>\n
      Body weight 70 kg<\/td>\n\u4f53\u91cd70 kg<\/span><\/td>\n\u4f53\u91cd70kg<\/span><\/td>\nNo space. Unit immediately follows numeral in medical Japanese.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

      [FM002] Percentage and Ratio Format<\/strong><\/p>\n\n\n\n\n\n\n
      Source (English)<\/strong><\/th>\n\u2717 Incorrect<\/strong><\/th>\n\u2713 Correct<\/strong><\/th>\nRationale<\/strong><\/th>\n<\/tr>\n<\/thead>\n
      Incidence rate of 3.5%<\/td>\n\u767a\u73fe\u73873.5 %\uff08space\uff09<\/span><\/td>\n\u767a\u73fe\u73873.5%<\/span><\/td>\nNo space before % in Japanese medical documents.<\/td>\n<\/tr>\n
      1 in 10 patients<\/td>\n10\u4eba\u4e2d1\u4eba or 10\u5206\u306e1<\/span><\/td>\n10\u4f8b\u4e2d1\u4f8b \/ 10.0%<\/span><\/td>\n\u4f8b preferred over \u4eba in clinical data expression. Percentage where data supports.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

      6.2 Brackets and Parentheses in Medical Content<\/h3>\n

      [FM003] Parenthetical Use for Abbreviations and Cross-References<\/strong><\/p>\n

      In Japanese medical regulatory documents, parentheses follow specific conventions for abbreviations, cross-references, and supplementary information.<\/p>\n\n\n\n\n\n\n
      Source (English)<\/strong><\/th>\n\u2717 Incorrect<\/strong><\/th>\n\u2713 Correct<\/strong><\/th>\nRationale<\/strong><\/th>\n<\/tr>\n<\/thead>\n
      Adverse events (AEs) were recorded.<\/td>\n\u6709\u5bb3\u4e8b\u8c61\uff08AEs\uff09\u3092\u8a18\u9332\u3057\u305f\u3002<\/span><\/td>\n\u6709\u5bb3\u4e8b\u8c61\uff08AE\uff09\u3092\u8a18\u9332\u3057\u305f\u3002<\/span><\/td>\nJapanese does not pluralize. AE not AEs. Parenthetical abbreviation retained in Latin characters.<\/td>\n<\/tr>\n
      See Section 4.2 (Contraindications)<\/td>\n\u30bb\u30af\u30b7\u30e7\u30f34.2\uff08\u7981\u5fcc\uff09\u3092\u53c2\u7167<\/span><\/td>\n\u300c4.2 \u7981\u5fcc\u300d\u306e\u9805\u3092\u53c2\u7167\u306e\u3053\u3068\u3002<\/span><\/td>\nSection reference convention in PMDA documents. \u306e\u9805 construction used.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

      7. QA Checklist \u2014 Japanese Medical<\/h2>\n

      \"1-StopAsiaApply this checklist before submitting any Japanese medical translation for review. Items marked [REGULATORY] are non-negotiable for PMDA submission documents.<\/p>\n

      Register and Style<\/h3>\n
        \n
      • [REGULATORY] Confirmed document type and applied correct register (\u3067\u3042\u308b\u8abf vs \u307e\u3059\u8abf)<\/li>\n
      • [REGULATORY] Passive construction used throughout regulatory submission procedures<\/li>\n
      • Non-assertive language applied in safety and warning sections<\/li>\n
      • Prohibition and instruction constructions confirmed against Section 2.3 matrix<\/li>\n<\/ul>\n

        Person Reference<\/h3>\n
          \n
        • Patient reference confirmed for document type (\u60a3\u8005 vs \u60a3\u8005\u3055\u3093 vs \u3042\u306a\u305f)<\/li>\n
        • Physician reference confirmed for document context<\/li>\n
        • [REGULATORY] Clinical trial physician titles confirmed (\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b \/ \u6cbb\u9a13\u62c5\u5f53\u533b\u5e2b)<\/li>\n
        • Second person ‘you’ handled correctly \u2014 not mechanically translated as \u3042\u306a\u305f<\/li>\n<\/ul>\n

          Terminology<\/h3>\n
            \n
          • [REGULATORY] AE \/ ADR \/ SAE distinction confirmed \u2014 not interchanged<\/li>\n
          • Frequency terms confirmed against PMDA standard where applicable<\/li>\n
          • Route of administration terms confirmed against Section 5.3<\/li>\n
          • Dosage form terms confirmed \u2014 regulatory vs patient-facing variants applied correctly<\/li>\n<\/ul>\n

            Katakana<\/h3>\n
              \n
            • [REGULATORY] Drug substance names verified against JP or PMDA approved term<\/li>\n
            • Disease names \u2014 kanji vs katakana confirmed against established medical use<\/li>\n
            • Procedure and device katakana confirmed \u2014 not generated from phonetic rules alone<\/li>\n
            • Elongation rules verified for medical terms (do not apply general JIS rules to medical katakana)<\/li>\n<\/ul>\n

              Format and Numbers<\/h3>\n
                \n
              • Arabic numerals used throughout \u2014 no kanji numerals in clinical\/regulatory content<\/li>\n
              • No space between numeral and unit (mg, kg, \u03bcg etc.)<\/li>\n
              • Percentage format confirmed \u2014 no space before %<\/li>\n
              • Parenthetical abbreviations confirmed \u2014 no plural ‘s’ in Latin abbreviations<\/li>\n
              • Section cross-reference format confirmed for document type<\/li>\n<\/ul>\n

                8. About This Guide<\/h2>\n

                This guide is part of the 1-StopAsia Orange Book Series, which is our published quality standards for Asian language content across core domains. The Orange Books document the standards our in-house linguistic teams apply when clients have not defined their own quality criteria.<\/p>\n

                We publish them because we believe quality in localization should be transparent, not assumed. An LSP or enterprise buyer working with 1-StopAsia on Japanese medical content should be able to understand exactly what standard their content will be held to and why.<\/p>\n

                Scope and Limitations<\/h3>\n

                This guide covers general Japanese medical localization quality standards applicable across pharmaceutical, medical device, and clinical document types. It does not substitute for:<\/p>\n

                  \n
                • Client-provided style guides, glossaries, or TM (which always take precedence)<\/li>\n
                • PMDA regulatory guidance documents (referenced here but not reproduced)<\/li>\n
                • Japan Pharmacopoeia monographs for specific substance naming<\/li>\n
                • Device-specific regulatory requirements under the PMDA Medical Device framework<\/li>\n<\/ul>\n

                  Updates and Feedback<\/h3>\n

                  This guide is reviewed annually by the 1-StopAsia Japanese medical QA team. Feedback from clients, reviewers, and project managers is incorporated into each revision. If you identify a case not covered by this guide or believe a standard documented here requires revision, contact your 1-StopAsia project manager.<\/p>\n

                  Related Orange Book Editions<\/h3>\n
                    \n
                  • Vietnamese Orange Book: Marketing Edition (published)<\/li>\n
                  • Chinese Simplified Orange Book: Financial Edition (published)<\/li>\n
                  • Japanese Orange Book: General Business Edition<\/li>\n
                  • Japanese Orange Book: Automotive Edition (forthcoming)<\/li>\n
                  • Japanese Orange Book: Financial Edition (forthcoming)<\/li>\n<\/ul>\n