What global regulators actually require for translating preclinical dossiers

The LATAM companion to this post opened with two inherited assumptions the industry has been paying for at the same time: (1) that preclinical documents must be sworn-translated page-for-page, and (2) that the entire preclinical corpus must be translated rather than the substantive summary. Both are largely wrong in the LATAM primary texts. This post asks whether they are any more right in the eight non-LATAM markets sponsors typically care about — FDA, EMA, PMDA, NMPA, MHRA, Health Canada, TGA, and Swissmedic.

The short answer is that both assumptions fare even worse globally. On visual replication and full-corpus translation, ICH's own M4 organisation guidance is silent on both translation and layout, and no primary instrument in any of the eight regulators requires either. On the sworn-translator standard, no regulator in the set imposes a sworn-plus-apostille ceiling on Module 4 or preclinical-adjacent documents; the two strongest certification standards we found (MHRA's certified translation with written confirmation of correctness, Swissmedic's applicant-attested translation) sit meaningfully below Argentina's traductor público matriculado standard. In other words: the LATAM post's argument that the sworn-page-for-page-plus-full-corpus default is a market convention rather than a regulatory one holds globally too, and the specialist discipline is LATAM, not the developed-market default.

Module 4 is the part of the CTD where sponsors most often assume language is a non-issue: toxicology and PK reports are scientific, GLP-generated, and usually written once in English for global reuse. Outside LATAM that assumption mostly holds — but not because regulators have harmonised. It holds because most of the eight regulators surveyed here either (a) mandate a single working language for the whole dossier and happen to accept English (FDA, MHRA, TGA), (b) name English as an accepted dossier language alongside national languages (Health Canada, Swissmedic), or (c) leave the language of the technical dossier to national discretion while treating English as the de facto standard (EU under Regulation 536/2014). Two of the eight break the pattern outright: Japan requires Japanese as a matter of law and permits English only under a narrow, time-limited administrative measure (PMDA FAQ Q2-9; MHLW Administrative Notice, 6 September 2024), and China requires the entire submission dossier in Chinese with the foreign-language original attached as reference (CDE/NMPA eCTD 技术规范 V1.0, §3.5).

The analytical question this post answers is therefore narrower and more useful than "which regulators accept English": it is where in the eight regimes does a translation obligation attach to Module 4 content, and what certification standard applies when it does. The answer is that the language obligation is almost never written into a Module 4-specific instrument. It sits in a general "language of the application" clause (21 CFR 312.23(c), HMR 2012 reg. 49(6), MHCTR reg. 16(4)) or in a format/dossier-preparation guidance (Health Canada CTD guidance §4.3, TGA general dossier requirements, Swissmedic ZL000_00_019 §5.6, NMPA eCTD guidance §7.1). Certification standards, where stated at all, are weaker than LATAM sworn-translator regimes: the two explicit standards found are MHRA's "certified translation … together with confirmation in writing that the translation is correct" (International Recognition Procedure §7.6) and Swissmedic's applicant-attested model (ZL000_00_019 §5.6).

Scope disclaimer: this piece covers Module 4 (nonclinical pharmacology, PK and toxicology study reports) only, plus the cover documents and patient-facing artifacts that sit adjacent to it in the same submission. It does not restate language rules for Module 3 quality data, Module 5 clinical study reports, product information/labelling approval texts (beyond noting them as nuance), or medical devices. No LATAM regulator is covered here — see the LATAM companion post for that. Where a regulator's public guidance does not address Module 4 language, this document says "n.a." and says why, rather than inferring a rule.

### On visual replication

None of the eight regulators, and none of the international harmonisation bodies, require a translated preclinical document to visually replicate the source. FDA's eCTD guidance is highly prescriptive on Study Tagging Files and datasets for Module 4 but silent on language and layout (FDA eCTD §III.L). ICH M4 specifies document granularity and one-document-per-study-report conventions and says nothing about visual fidelity of translations (ICH M4). IPRP's Good Reliance Practices Repository catalogues what reliance authorities require of applicants and imposes no visual-fidelity rule (IPRP GRP v1.0). Where regulators impose formatting rules at all, they are printing rules (page size, legible font, split-oversized-reports conventions) not visual-replication rules.

### On full-corpus translation

Six of the eight regulators either mandate English (FDA, MHRA, TGA) or accept English as an operative dossier language (Health Canada, Swissmedic, EMA centralised) for Module 4 — which resolves the full-corpus-translation question at source: if English is the accepted or required language, there is nothing to translate. The two that require the national language (Japan and China) still allow English for the Module 4 portion under stated conditions — Japan under the September 2024 MHLW notice for eligible foreign companies (MHLW notice), China as `xml:lang`-tagged foreign-language reference material alongside the Chinese dossier of record (NMPA eCTD §3.5). Neither imposes a full-corpus-translation obligation in the LATAM sense; the operative rule is dossier language, not translation volume.

The corollary is that outside LATAM the industry's cost problem is not "translate thousands of pages we didn't need to translate" — because the language rule mostly resolves in English's favour — it is "generate certified-translation deliverables when a lighter applicant-attested confirmation would satisfy the regulator." That is Assumption 1 (the sworn-page-for-page default) restated. Assumption 2 (full-corpus vs. summary) is the LATAM-specific cost trap, not a global one.

Official languages of submission. English. There is no provision accepting any other language; the regulations operate by requiring translation of anything not in English — "The sponsor shall submit an accurate and complete English translation of each part of the IND that is not in English" (21 CFR 312.23(c)), and for NDAs, "The applicant must submit an accurate and complete English translation of each part of the NDA that is not in English" (21 CFR 314.50(g)(2)).

Module 4 English acceptability. Yes — English-only is not merely acceptable, it is the operative requirement. Nonclinical pharmacology and toxicology content is a required technical section of the NDA (21 CFR 314.50(d)(2)), and the English-translation duty in 314.50(g)(2)/312.23(c) applies to "each part" of the application, with no Module 4 carve-out (21 CFR 312.23(c)).

Certified / sworn translation trigger. None found. Neither 21 CFR 312.23 nor 314.50 requires a certified, sworn or notarised translation; the standard is substantive ("accurate and complete") and is placed on the sponsor/applicant, with the additional duty to file a copy of each original foreign-language literature publication for which a translation is submitted (21 CFR 312.23(c); 21 CFR 314.50(g)(2)). FDA's eCTD guidance sets format, dataset and Study Tagging File rules for Module 4 but states no language or translation requirement (Providing Regulatory Submissions in Electronic Format — eCTD, §III.L).

Primary instrument citation. 21 CFR 312.23(c) "Material in a foreign language" (text) for INDs; 21 CFR 314.50(g)(2) (text) for NDAs; format-only companion: Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (FDA guidance PDF).

Nuance. The English rule is dossier-wide, but the patient-facing obligation runs on a different axis: informed-consent information "shall be in language understandable to the subject or the representative" (21 CFR 50.20) — so a US IND supported by Module 4 in English can still generate certified-translation work on the consent side. Note also the sponsor-side evidentiary trap: the original foreign-language publication must accompany the translation, meaning translated literature references in 4.3 travel as bilingual pairs (21 CFR 312.23(c)).

Official languages of submission. For the centralised procedure, English — "All applications for the centralised procedure must be submitted in English" (EMA pre-authorisation guidance), and "English should be used for a centralised procedure … English should be used for a mutual recognition or decentralised procedure" (EMA application form user guide). For national procedures the applicable languages are set per Member State in the CMDh document Languages to be used for Marketing Authorisation Applications (MAAs), Variations and Renewals (CMDh, December 2020). For clinical trials under CTR 536/2014, "The language of the application dossier, or parts thereof, shall be determined by the Member State concerned" (Regulation (EU) 536/2014, Art. 26).

Module 4 English acceptability. Yes in practice, by two different routes. Centralised MAA: the whole application including Modules 2–5 is filed in English (EMA pre-authorisation guidance). CTA: nonclinical pharmacology and toxicology data sit in the IMPD "in a logical structure, such as that of Module 4 of the ICH Common Technical Document format" (CTR Annex I, section G), and Member States were asked to "consider accepting, for the documentation not addressed to the subject, a commonly understood language in the medical field" (Art. 26, second paragraph); the Commission CTR Q&A records that Member States "have indicated in annex II which documents from the part I … can be accepted in English" and states flatly "English is the accepted standard" (CTR Q&A, ¶67 and Annex II NOTA BENE).

Certified / sworn translation trigger. No EU-level certified or sworn translation standard was found for Module 4 content. The only translation duty expressed in CTR 536/2014 itself is conditional and untied to certification: third-country inspection reports must be translated "when requested by a Member State concerned … in an official language of the Union indicated in the request" (Art. 53(2)). For MAAs, "Language requirements apply also to the annexes to the Application form and therefore, as applicable, translations may need to be provided," again with no certification standard specified (EMA application form user guide).

Primary instrument citation. Regulation (EU) No 536/2014, Article 26 (language requirements) and Annex I section G (nonclinical data in Module 4 structure) (EUR-Lex); Questions & Answers — Regulation (EU) 536/2014, Q&A 1.21 and Annex II "Language for part I documents and translated Patient Facing Documents submitted in Part II" (European Commission); EMA pre-authorisation guidance (EMA).

Nuance. The EU's multi-language pack burden lands on Part II and on product information, not on Module 4: translated patient-facing documents are submitted in Part II in the national language per Annex II, while "All Member States accept in Part I Patient Facing Documents in English (or in the national language in case the trial is mononational)" (CTR Q&A Annex II). Post-opinion, MAA holders must deliver product-information annexes "in all EU languages, plus Icelandic and Norwegian" by Day 215 with final translations by Day 235 (EMA pre-authorisation guidance).

Official languages of submission. Japanese, as the default legal position — "No, PMDA does not accept applications in other languages. Japan's Pharmaceutical Affairs Law requires all forms related to the marketing application to be submitted in Japanese" (PMDA FAQ Q2-9).

Module 4 English acceptability. Yes, and it predates the current pilot: MHLW records that "we had previously allowed CTD Parts 3, 4, and 5 listed in Section 3 of the Director's Notification to be submitted in English," and as a trial measure now permits "the entire document, including the written application for approval and the draft package insert, in English at the time of submission of the application" (MHLW Administrative Notice, 6 September 2024, §1(1)). The English-for-everything measure is bounded: it applies "for the time being" to "foreign companies without a Japanese corporation or office in Japan," limited to drugs listed in items (1)–(3) of Appendix 2-(1) of PFSB Notification No. 1121-2 (21 November 2014), and requires advance consultation with PMDA's Office of Review Management (§1(2) and §1(3)).

Certified / sworn translation trigger. None stated. The 2024 administrative notice contains no requirement for certified, sworn or notarised translation, no translator-qualification standard, and no notarisation/legalisation/apostille provision (MHLW Administrative Notice, 6 September 2024). PMDA's FAQ likewise states no translation-certification standard (PMDA FAQ).

Primary instrument citation. Submitting documents to be attached in the application for approval of new ethical drugs, MHLW Pharmaceutical Safety Bureau Administrative Notice, 6 September 2024 (provisional English translation) (PMDA PDF), which itself sits on top of the "Drug Approval Applications" notification PFSB No. 1121-2 of 21 November 2014 and the earlier CTD attachment-document guidelines (PSB/ED Notification No. 899, 21 June 2001) as cited in that notice (same PDF).

Nuance. Japan is the one regulator in this set where Module 4 English acceptability is a concession, not a baseline, and where the concession is conditioned on the applicant's corporate footprint and on pre-submission consultation (§1(2)–(3)). A commonly repeated "Japanese abstract/summary required" claim could not be confirmed from a fetched PMDA or MHLW source — the September 2024 notice does not state any obligation to supply a Japanese translation later (MHLW notice) — so that point is n.a. here; separately, PMDA states its working language is Japanese and that consultation-track materials are Japanese-based (PMDA FAQ).

Official languages of submission. Chinese, with the foreign-language original attached — "申请人提交的全部申报资料应当使用中文并附原文，其他文种的资料可附后作为参考。中文译文应当与原文内容一致" ("all dossier materials submitted by the applicant shall use Chinese with the original attached; materials in other languages may be appended as reference; the Chinese translation shall be consistent in content with the original") (CDE/NMPA eCTD 技术规范 V1.0, §3.5; identical wording at eCTD 实施指南 V1.0, §7.1).

Module 4 English acceptability. No — not as the dossier of record. The Chinese-language rule is expressed as applying to "全部申报资料" (all dossier materials), and foreign-language files are classified in the eCTD backbone as 外文参考资料 (foreign-language reference material), tagged via the `xml:lang` attribute and placed after the Chinese dossier leaf in the same directory element (eCTD 技术规范 V1.0, §3.5 and §3.5.1). Module 4 is addressed only structurally: sections 4.2.X must be organised with Study Tagging Files, and nonclinical study reports are tagged "pre-clinical-study-report" (§3.8; 实施指南 §4.4) — with no exemption from the Chinese-language rule for Module 4.

Certified / sworn translation trigger. None found. The eCTD technical specification and implementation guidance impose a substantive equivalence standard ("中文译文应当与原文内容一致") but do not require a certified, sworn or notarised translation, do not name who must translate, and do not require a translator declaration or seal (eCTD 技术规范 V1.0 §3.5; eCTD 实施指南 V1.0 §7.1). What is required is an applicant undertaking that the electronic dossier is completely consistent with the paper dossier, with legal liability for falsity (eCTD 实施指南 cover-letter template item 5; see also the paper-copy and consistency commitment in the NMPA eCTD implementation announcement, §II).

Primary instrument citation. eCTD 技术规范 V1.0, §3.5 "外文参考资料的要求" (NMPA PDF) and eCTD 实施指南 V1.0, §7.1 "外文在提交资料中的要求" / §4.4 "模块四：非临床试验报告" (NMPA PDF), issued under the Provisions for Drug Registration framework (NMPA English text, Arts. 8 and 10) and the NMPA announcement on eCTD implementation.

Nuance. The NMPA design is the mirror image of the US model: the Chinese version is the dossier, the English original is reference material with reduced eCTD validation exposure ("语言属性设置为外文的参考资料将不受某些eCTD验证标准的约束") (eCTD 实施指南 §7.1). Note also that the English-language Provisions for Drug Registration posted by NMPA is silent on language — it addresses overseas dossiers only through ICH-conformity and GLP requirements (Art. 10) — so the operative language rule must be cited from the Chinese eCTD instruments, which NMPA does not publish in official English translation.

Official languages of submission. English, by statute. For marketing authorisations: "The application and any accompanying material must be in English" (Human Medicines Regulations 2012, reg. 49(6)). For clinical trials under the amended regime: "The request for approval and accompanying material must be supplied in English" and, for modifications, "The modification request and accompanying material … must be supplied in English" (Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, regs. 16(4) and 22(7)).

Module 4 English acceptability. Yes — and mandatory. The CTA dossier must include "data from non-clinical studies and from clinical use of the product" (Sch. 3 Part A1, para. 5(b)(iii)), and that material falls within "accompanying material" caught by the English requirement in reg. 16(4) (same); the MA equivalent is reg. 49(6) read with reg. 50 and Schedule 8 (HMR 2012).

Certified / sworn translation trigger. MHRA states the clearest certification standard of the eight, in the reliance route: "All RR documents submitted in support of an IRP application to MHRA must be in English. A certified translation for any original documents that are not in English together with confirmation in writing that the translation is correct is required" (International Recognition Procedure, §7.6). Because IRP reference-regulator packages expressly include non-clinical assessment reports — e.g. Health Canada "non-clinical report", TGA and Swissmedic "all assessment reports including quality, non-clinical and clinical", FDA "non-clinical review(s)", and for PMDA "unredacted English translated review reports and outcome" — the certified-translation trigger reaches preclinical-adjacent documents directly (IRP §10). MHRA does not specify translator qualifications, notarisation or a court-listed sworn translator (same).

Primary instrument citation. Human Medicines Regulations 2012 (SI 2012/1916), regs. 49(6) and 50 (legislation.gov.uk); Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (SI 2025/538), regs. 16(4), 22(7) and Sch. 3 Part A1 (legislation.gov.uk); MHRA International Recognition Procedure guidance, §§7.6 and 10 (GOV.UK).

Nuance. The UK's translation risk is concentrated not in generating Module 4 (usually English-native) but in importing foreign regulators' non-clinical assessment reports for IRP, each of which needs a certified translation plus written confirmation of correctness if not originally in English (IRP §§7.6, 10). Neither SI 2025/538 nor HMR 2012 reg. 49 imposes any certification standard on translations, so the certification bar is set by guidance, not statute (SI 2025/538; HMR 2012).

Official languages of submission. English or French — "Information in the regulatory activity should be recorded in either English or French" (Health Canada, Preparation of Drug Submissions in the CTD Format, §4.3 "Language").

Module 4 English acceptability. Yes. Module 4 nonclinical study reports are prepared per ICH M4S (Health Canada, Preparation of Regulatory Activities in the eCTD Format, §2.4.2) and the §4.3 language rule accepts either official language for the regulatory activity, with translation required only for material in a third language: "Material in a different language should be accompanied by an English or French translation with the possible exception of Case Report Forms (consult the appropriate Bureau (TPD) or the Office of Regulatory Affairs (BGTD) first)" (CTD guidance §4.3). There is no obligation to translate an English Module 4 into French (same).

Certified / sworn translation trigger. None found. The CTD guidance requires a translation into English or French for third-language material but states no certification, swearing, notarisation or applicant-attestation standard (§4.3); the eCTD guidance and the submission-management guidance are silent on language and translation altogether (eCTD guidance; Management of Drug Submissions and Applications, §8.1).

Primary instrument citation. Guidance for Industry: Preparation of Drug Submissions in the Common Technical Document (CTD) Format, §4.3 "Language" (Health Canada PDF); Guidance Document: Preparation of Regulatory Activities in the Electronic Common Technical Document (eCTD) Format, §2.4.2 (Module 4 / ICH M4S) (Health Canada PDF), both issued under the Food and Drugs Act and Part C of the Food and Drug Regulations (eCTD guidance, scope).

Nuance. For clinical trials, the Module 4 question largely disappears: Health Canada's CTA is "composed of three parts (modules) in accordance with the CTD format" — Modules 1, 2 (quality summaries) and 3 (quality) — with no Module 4 in the CTA table of contents (Guidance for Clinical Trial Sponsors: Clinical Trial Applications). Bilingualism bites at the labelling/product-monograph end instead: directions for use must be in both French and English for drugs sold in an open self-selection area under s. A.01.015(2), and second-language Product Monograph versions are due no later than 20 days after an NDS is accepted into review (Labelling of pharmaceutical drugs for human use, §2.2 and footnote 3; see also the second-language PM format table at eCTD guidance §3.1).

Official languages of submission. English. "Make sure that either all information is in English and readable"; for information not in English the dossier must include "a copy of the information in the original language" and "a full translation of the information in English" (TGA, General dossier requirements, Part A). The same rule applies to clinical-trial (CTX) applications: "All information supporting an application must be in English and must be legible. Where material is not originally in English a full translation must be submitted together with the original documentation" (TGA, Access to unapproved therapeutic goods — Clinical trials in Australia, Administrative Requirements for CTX Applications, p. 59).

Module 4 English acceptability. Yes — English is required, and Module 4 content is expressly in scope of the dossier as "Nonclinical data (addressing safety and efficacy) (consistent with CTD Module 4)", covering pharmacology, PK (including analytical methods and validation reports) and toxicology (TGA, Information required in an application for a new registered medicine). For CTX, the pharmaco-toxicological documentation is Part 3 of the application (clinical trials guidance, p. 53).

Certified / sworn translation trigger. TGA sets a certified-translator trigger for any non-English source document in a registration application: "If original documentation is in another language, it should be translated to English by a certified translator and both the English version and the original document should be provided. Non-English documents without certified translations and non-certified translations will not be considered as valid data" (TGA, Information required in an application for a new registered medicine). The general dossier guidance frames accuracy as the sponsor's responsibility and points to NAATI as the source of qualified translators without mandating NAATI certification: "You are responsible for the accuracy of the translation. If you need assistance, you can search for a qualified translator through the National Accreditation Authority for Translating and Interpreting (NAATI) website" (General dossier requirements).

Primary instrument citation. TGA General dossier requirements (Part A: "English") (TGA PDF); TGA Information required in an application for a new registered medicine (language + Module 4 nonclinical data list) (TGA); TGA Access to unapproved therapeutic goods — Clinical trials in Australia, CTX administrative requirements ("Language") (TGA PDF).

Nuance. Australia is the only regulator in this set that pairs a hard evidentiary sanction with the certification standard — uncertified translations "will not be considered as valid data," which converts a translation defect in a Module 4 study report of foreign origin into a data-sufficiency problem, not just an administrative one (TGA). The two TGA statements sit in tension (sponsor-attested accuracy in the general dossier guidance vs. certified translator for new registered medicines), so the conservative read for Module 4 is the certified-translator standard (General dossier requirements; new registered medicine guidance).

Official languages of submission. A Swiss official language or English — "The documentation (Modules 2 to 5 and the country-specific Module 1 or Parts I - IV) … must be submitted to Swissmedic in one of Switzerland's official languages or in English" (Swissmedic, Guidance document Authorisation human medicinal products under Art. 13 TPA (ZL000_00_019), §5.6).

Module 4 English acceptability. Yes, explicitly — the §5.6 rule names Modules 2 to 5, which includes Module 4 nonclinical documentation; Module 4 content itself must follow ICH M4S ("The presentation must conform to ICH M4S") and a new-active-substance application requires "Complete preclinical documentation: Modules 2.4, 2.6 and 4" (Swissmedic, Authorisation of human medicinal product with new active substance (ZL101_00_005), §§5.2.4 and 5.4.1.1; ZL000_00_019 §5.6).

Certified / sworn translation trigger. Swissmedic accepts an applicant-attested standard rather than sworn translation: "Translations into one of these languages are also accepted, provided that the applicant confirms in writing that the translations are correct," with the corresponding deliverable listed as "For translations: confirmation that the translations are correct"; the scope condition repeats it — "The documents are available in an official language, in English or in a translation into one of these languages. If a translation is submitted, the applicant must confirm that it is correct" (ZL000_00_019, §§3, 5.6 and 11.1). No notarisation, legalisation or apostille requirement appears in that guidance (same).

Primary instrument citation. Swissmedic Guidance document Authorisation human medicinal products under Art. 13 TPA, ZL000_00_019, §5.6 "Requirements regarding languages and translation of the documentation" (Swissmedic PDF); Guidance document Formal requirements, ZL000_00_020, v19.0 (product-information language, §2.5.3.2) (Swissmedic PDF); Medicinal Products Licensing Ordinance (AMZV, SR 812.212.22), Annex 4 no. 1(1) requiring draft product-information texts "in einer der drei Amtssprachen" (Swissmedic-hosted AMZV PDF).

Nuance. Switzerland's three-language problem is quarantined to product information, not Module 4: "The information for healthcare professionals and patients for human medicinal products … must be submitted in an official Swiss language for approval" (ZL000_00_020 §2.5.3.2), and AMZV Annex 4 requires draft texts in one of the three official languages, with all three required where a package leaflet is waived under Art. 14(2) (AMZV, Annex 4 no. 1(1) and 1(4)). Caveat for citation discipline: the explicit "Modules 2 to 5 in an official language or English" wording is published in the Art. 13 (foreign-approved product) guidance; Swissmedic's general Formal requirements guidance does not state a Modules 2–5 language rule (ZL000_00_020).

Two structural observations. First, Tier 1-A in the LATAM sense — apostilled or sworn-translator-certified legal instruments — has no confirmed analogue in any of the eight regimes for Module 4 or its cover documents from the sources fetched; the closest equivalents are MHRA's certified-translation-plus-written-confirmation rule (IRP §7.6) and Swissmedic's applicant-confirmation deliverable (ZL000_00_019 §11.1). Second, Tier 1-B never reaches Module 4 in any of the eight; patient-facing language obligations run through consent documents (21 CFR 50.20), CTR Part II (Q&A Annex II), and product information/labelling (Health Canada; Swissmedic; EMA).

There is no harmonised international default. ICH's own CTD architecture is silent on language: the M4 organisation guidance specifies document granularity, table-of-contents depth and one-document-per-study-report conventions for Module 4, and says nothing about submission language, translation, or translator certification (ICH M4 Organisation of the CTD, Module 4 / Table 5). IPRP's Good Reliance Practices Repository — the most obvious place to look for a convergent multi-regulator rule, since it catalogues what reliance-using authorities require from applicants — likewise contains no language, translation or certification requirement, only dossier-content and assessment-report expectations (IPRP, Good Reliance Practices Repository v1.0, 8 October 2024). FDA's eCTD guidance is similarly silent on language while being highly prescriptive about Module 4 STFs and datasets (FDA eCTD guidance §III.L).

The one internationally-published, explicit standard found is WHO's, and it is the most defensible fallback precisely because it is stated as a general dossier rule rather than a jurisdiction-specific formality: "Information in the product dossier shall be in English (unless other arrangements have been made with WHO before submission of the dossier)," and "Any document provided in a language other than English shall be accompanied by a certified translation that is signed and dated by the translator and where the translator has stated that it is a true and accurate translation of the original document" (WHO, Instructions for compilation of a product dossier, §D.5). WHO separately requires notary-or-manufacturer certification for copies of regulatory approval evidence and publishes a model declaration of authenticity for certified/notarised copies (§1.7 and Annex 2) — a clean template for the narrow Tier 1-A-type documents (certificates, approvals, powers) that accompany a preclinical-bearing dossier.

Operationally, the defensible default position where a regulator is silent on Module 4 is a three-part stack, each element traceable to a regulator that does state it: (1) file Module 4 in English, since English is the required or accepted dossier language for six of the eight regulators here and the accepted Part I standard in the EU (FDA; MHRA; TGA; Health Canada; Swissmedic; EU CTR Q&A); (2) keep the source-language original in the dossier alongside the translation, which is an express requirement of FDA for translated literature, TGA for all non-English material, and NMPA for the foreign-language reference set (21 CFR 312.23(c); TGA; NMPA eCTD 技术规范 §3.5); and (3) attach the highest certification artefact any target regulator has articulated — a translator-signed, dated statement that the translation is true and accurate (WHO §D.5), which simultaneously satisfies TGA's "certified translator" test (TGA), MHRA's "certified translation together with confirmation in writing that the translation is correct" (IRP §7.6), Swissmedic's applicant confirmation of correctness (ZL000_00_019 §5.6), and NMPA's content-consistency test (§3.5).

Two silence-specific cautions. Where a regulator's pilot or conditional regime supplies the English acceptability — Japan being the case in point — the conservative default is to confirm eligibility and consult before relying on it, because the notice itself requires advance consultation and limits both company scope and product scope (MHLW notice §1(2)–(3)). And where the regulator publishes its language rule only in the national language — China being the case in point, since NMPA's English-language Provisions for Drug Registration is silent on language while the Chinese eCTD instruments are not (English text; Chinese eCTD 技术规范) — a sponsor relying on English-language regulator pages alone will systematically under-read its translation obligation. Treat absence of an English-language statement as an evidence gap, not as permission.