{"product_id":"ich-m-dossier-ctd-ectd-v4-guida-operativa","title":"ICH M Multidisciplinary Guidelines: the CTD dossier, eCTD v4.0 and what actually applies","description":"\u003cdiv style=\"font-family:-apple-system,BlinkMacSystemFont,'Segoe UI',Roboto,Helvetica,Arial,sans-serif;color:#1A1C10;line-height:1.65\"\u003e\n\u003c!-- BLOCK:hero --\u003e\n\u003cdiv style=\"background:#12140A;border-radius:14px;padding:34px 30px 30px 30px;color:#ffffff;margin-bottom:26px\"\u003e\n\u003cdiv style=\"display:inline-block;background:#D4C35A;color:#12140A;font-size:12px;font-weight:700;letter-spacing:1.6px;text-transform:uppercase;padding:6px 12px;border-radius:4px;margin-bottom:16px\"\u003eSecond edition · September 2026 · regulatory cut-off 23 September 2026\u003c\/div\u003e\n\u003ch3 style=\"margin:0 0 12px 0;font-size:29px;line-height:1.25;color:#ffffff;font-weight:800\"\u003eOne harmonised format, five calendars: what in the ICH M series actually applies, where and from when.\u003c\/h3\u003e\n\u003cp style=\"margin:0 0 20px 0;font-size:16px;color:#F3F0D8;max-width:680px\"\u003eIn the European Union the dossier in five modules is law (Annex I to Directive 2001\/83\/EC); the other M guidelines are scientific guidelines, to be followed or departed from with a justification. In the United States the CTD comes in through the eCTD door. And eCTD v4.0 is a single ICH specification with different regional calendars. This guide reads the M series from M1 to M18 text by text, with version, status and jurisdiction: \u003cstrong\u003e27 chapters in six parts\u003c\/strong\u003e, 261 pages in the English edition, 259 in the Italian, and 17 editable tools, for €129.\u003c\/p\u003e\n\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:9px\"\u003e\n\u003cspan style=\"background:#1C2010;color:#F3F0D8;font-size:13px;padding:7px 13px;border-radius:20px\"\u003e261 pages (ENG) · 259 (ITA) · A4 PDF\u003c\/span\u003e\u003cspan style=\"background:#1C2010;color:#F3F0D8;font-size:13px;padding:7px 13px;border-radius:20px\"\u003e27 chapters in six parts + 5 appendices\u003c\/span\u003e\u003cspan style=\"background:#1C2010;color:#F3F0D8;font-size:13px;padding:7px 13px;border-radius:20px\"\u003e17 editable tools: 10 Excel + 7 Word\u003c\/span\u003e\u003cspan style=\"background:#1C2010;color:#F3F0D8;font-size:13px;padding:7px 13px;border-radius:20px\"\u003eThe M series from M1 to M18\u003c\/span\u003e\u003cspan style=\"background:#1C2010;color:#F3F0D8;font-size:13px;padding:7px 13px;border-radius:20px\"\u003eeCTD v3.2.2 → v4.0\u003c\/span\u003e\u003cspan style=\"background:#1C2010;color:#F3F0D8;font-size:13px;padding:7px 13px;border-radius:20px\"\u003e195 sources in the register\u003c\/span\u003e\u003cspan style=\"background:#1C2010;color:#F3F0D8;font-size:13px;padding:7px 13px;border-radius:20px\"\u003e147 decisions tracked\u003c\/span\u003e\n\u003c\/div\u003e\u003c\/div\u003e\n\u003c!-- BLOCK:langnote --\u003e\n\u003cdiv style=\"background:#FAF8EE;border:1px solid #E6E2C8;border-left:4px solid #8F7E24;border-radius:0 11px 11px 0;padding:16px 20px;margin-bottom:26px;font-size:14.5px;color:#1A1C10\"\u003e\u003cstrong style=\"color:#5C5214\"\u003eTwo separate editions: you choose the language.\u003c\/strong\u003e The guide and the toolkit exist as an Italian edition and as an English edition, identical in structure. Choose the \u003cstrong\u003eITA - Italiano\u003c\/strong\u003e or the \u003cstrong\u003eENG - English\u003c\/strong\u003e variant: the purchase gives access to the edition you choose.\u003c\/div\u003e\n\u003c!-- BLOCK:cards3 --\u003e\n\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:14px;margin-bottom:26px\"\u003e\n\u003cdiv style=\"flex:1 1 230px;background:#FAF8EE;border:1px solid #E6E2C8;border-top:3px solid #8F7E24;border-radius:11px;padding:19px\"\u003e\u003cdiv style=\"font-size:12px;font-weight:700;color:#5C5214;letter-spacing:1.2px;text-transform:uppercase;margin-bottom:7px\"\u003eThe guide\u003c\/div\u003e\u003cdiv style=\"font-size:15px;color:#1A1C10\"\u003e27 chapters in six parts: the legal force of the M series, the CTD module by module under M4(R4), the eCTD from v3.2.2 to v4.0, the scientific guidelines (M3(R2), M7(R2), M9 to M15), the jurisdictions, readiness. Every chapter follows the same path — \u003cstrong\u003etext → version and status → force in the jurisdiction → date → applicant's decision → document in which it is recorded → how it is demonstrated\u003c\/strong\u003e — and closes with the decisions it produces.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 230px;background:#FAF8EE;border:1px solid #E6E2C8;border-top:3px solid #8F7E24;border-radius:11px;padding:19px\"\u003e\u003cdiv style=\"font-size:12px;font-weight:700;color:#5C5214;letter-spacing:1.2px;text-transform:uppercase;margin-bottom:7px\"\u003eThe toolkit\u003c\/div\u003e\u003cdiv style=\"font-size:15px;color:#1A1C10\"\u003e17 editable tools per edition: 10 Excel workbooks and 7 Word documents, each with an instructions section stating purpose, chapter of origin, who completes it and who approves it. The first is the M-series applicability matrix by jurisdiction: for every M text and every eCTD specification, label, date, legal force and source.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 230px;background:#FAF8EE;border:1px solid #E6E2C8;border-top:3px solid #8F7E24;border-radius:11px;padding:19px\"\u003e\u003cdiv style=\"font-size:12px;font-weight:700;color:#5C5214;letter-spacing:1.2px;text-transform:uppercase;margin-bottom:7px\"\u003eLifetime updates\u003c\/div\u003e\u003cdiv style=\"font-size:15px;color:#1A1C10\"\u003eThe framework moves, and some dates are already set: in the EU, eCTD v4.0 is strongly recommended from \u003cstrong\u003eQ1 2027\u003c\/strong\u003e and mandatory from \u003cstrong\u003eQ1 2028\u003c\/strong\u003e for new centralised MAAs only; M4Q(R2) is still a DRAFT, with Step 4 planned for June 2027; M13B, adopted in August 2026, comes into effect in the EU on \u003cstrong\u003e17\/03\/2027\u003c\/strong\u003e; the ICH Assembly in Prague (14–18\/11\/2026) may change the status of M4Q(R2) and of the topics in development. When the texts change you receive the revised guide and toolkit at no extra cost.\u003c\/div\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c!-- BLOCK:price --\u003e\n\u003cdiv style=\"background:#FAF8EE;border-left:4px solid #8F7E24;border-radius:0 11px 11px 0;padding:22px 24px;margin-bottom:30px\"\u003e\n\u003cdiv style=\"font-size:19px;font-weight:800;color:#5C5214;margin-bottom:10px\"\u003e€129, and a snapshot dated 23 September 2026\u003c\/div\u003e\n\u003cp style=\"margin:0 0 11px 0;font-size:15px;color:#1A1C10\"\u003eThis edition has been rewritten from scratch on the official sources as read on \u003cstrong\u003e23 September 2026\u003c\/strong\u003e. The first edition did not cover eCTD v4.0 and carried CTD section numbers that do not hold; this one has a register of \u003cstrong\u003e195 sources\u003c\/strong\u003e with URL and access date, and a status label on every document it cites.\u003c\/p\u003e\n\u003cp style=\"margin:0 0 11px 0;font-size:15px;color:#1A1C10\"\u003eThe price is \u003cstrong\u003e€129.00\u003c\/strong\u003e. Second edition, September 2026, version 2.0, with a regulatory verification cut-off of \u003cstrong\u003e23 September 2026\u003c\/strong\u003e: 261 pages in the English edition, 259 in the Italian, 27 chapters, 5 appendices and 17 editable tools. Buyers of the first edition receive this one at no extra cost.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c!-- BLOCK:tools --\u003e\n\u003ch3 style=\"font-size:22px;margin:0 0 6px 0;color:#12140A\"\u003eThe 17 tools in the toolkit\u003c\/h3\u003e\n\u003cp style=\"margin:0 0 18px 0;font-size:15px;color:#626150;max-width:720px\"\u003eTen Excel and seven Word, 17 files per edition. \u003cstrong\u003eNo operational value is preloaded.\u003c\/strong\u003e Internal publishing timelines, number of reviewers, gap assessment thresholds and weightings, leaf title and file name lengths, surveillance frequencies: they are “to be defined” placeholders, because no official source sets them for the applicant. Regulatory dates and statuses go in only with their source alongside. Example rows concern Arvena Pharma, a fictitious company, and are marked EXAMPLE.\u003c\/p\u003e\n\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:12px;margin-bottom:28px\"\u003e\n\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #E6E2C8;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#12140A;margin-bottom:5px\"\u003e01 · M-series applicability matrix by jurisdiction\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#626150\"\u003eWhat applies, where, from when and with what force. For every M text and every eCTD specification, each jurisdiction's cell already carries label, date, legal force and source; the verification log keeps the date of the last check row by row.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #E6E2C8;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#12140A;margin-bottom:5px\"\u003e02 · CTD map and completeness checklist, Modules 1–5\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#626150\"\u003eEvery applicable section has its document, and every “not applicable” section has its justification. Status by section and completeness of the dossier; non-EU Module 1 is left to be completed for the region concerned.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #E6E2C8;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#12140A;margin-bottom:5px\"\u003e03 · eCTD v4.0 Transition Readiness Assessment\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#626150\"\u003eReadiness for v4.0 by application, region and application type, with the correct regional reference for each: a date published by the authority, or “ICH table only”. No weighted score: dashboard and action plan.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #E6E2C8;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#12140A;margin-bottom:5px\"\u003e04 · Sequence and lifecycle register\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#626150\"\u003eSequences submitted, lifecycle operations (v3.2.2) or context of use (v4.0), and the current status of every document. It is the register that answers “which document is current in this section?”.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #E6E2C8;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#12140A;margin-bottom:5px\"\u003e05 · Leaf title and granularity checker\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#626150\"\u003eCompany rules for leaf titles, file names and granularity, with the outcome rule by rule. Lengths, characters and patterns are not prefilled: the company decides them and the sheet asks for them in writing.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #E6E2C8;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#12140A;margin-bottom:5px\"\u003e06 · Cross-module consistency register of the dossier\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#626150\"\u003eThe same key data point must carry the same value in the QOS, in Module 3, in the overviews and in actual practice. The register checks it against the source record and tracks discrepancies and actions.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #E6E2C8;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#12140A;margin-bottom:5px\"\u003e07 · M4Q(R2) Impact Assessment [DRAFT]\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#626150\"\u003eM4Q(R2) readiness without anticipating obligations: a justified impact, product by product, on the ICH mapping, and an event-driven roadmap with windows relative to Step 4. It never carries the requirement label and is redone when the text becomes final.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #E6E2C8;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#12140A;margin-bottom:5px\"\u003e08 · Bioequivalence pathway selector (M9\/M13A\/M13B\/EMA 1401)\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#626150\"\u003eJurisdiction, dosage form, question, BCS class, NTI: the selector tells you which text governs the bioequivalence question, with label and source. It is built on one precise fact: M13A does not replace the EMA bioequivalence guideline.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #E6E2C8;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#12140A;margin-bottom:5px\"\u003e09 · Agency questions and commitments tracker\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#626150\"\u003eQuestions received and commitments made, through to closure, with status and dashboard. No real questions preloaded; the ageing thresholds are set by the company.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #E6E2C8;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#12140A;margin-bottom:5px\"\u003e10 · Dossier gap assessment with dashboard\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#626150\"\u003eThe dossier against requirements and guidelines, with the nature of every row (requirement, guidance, good practice) and the assessment. Gaps, CAPA and justified deviations stay separate; no draft text enters the requirements.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #E6E2C8;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1B4D8F;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#12140A;margin-bottom:5px\"\u003e11 · SOP for the preparation, publishing and QC of eCTD submissions\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#626150\"\u003eThe sequence cycle from planning to archiving, with the QC checklist. Internal timelines, reviewers and frequencies are fields to be defined. Variation procedures are out of scope: they belong to the Regulatory Affairs guide.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #E6E2C8;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1B4D8F;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#12140A;margin-bottom:5px\"\u003e12 · SOP for core dossier governance and document lifecycle\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#626150\"\u003eA single dossier truth over time: core dossier, version control, link to change control, realignment of the dossier with actual practice. No classification of variations.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #E6E2C8;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1B4D8F;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#12140A;margin-bottom:5px\"\u003e13 · Quality Overall Summary template under M4Q(R1) with guidance\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#626150\"\u003eThe QOS as a summary of Module 3, section by section under M4Q(R1), with completion guidance and a worked example on the fictitious product ARV-050. Stability appears only as a location in the CTD.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #E6E2C8;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1B4D8F;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#12140A;margin-bottom:5px\"\u003e14 · Nonclinical and Clinical Overview template under M4S\/M4E with guidance\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#626150\"\u003eOverviews traceable to the study reports, under M4S(R2) and M4E(R2). No invented lengths: only those the sources state.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #E6E2C8;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1B4D8F;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#12140A;margin-bottom:5px\"\u003e15 · eCTD v4.0 transition plan\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#626150\"\u003eThe readiness from tool 03 turned into a plan: scope as portfolio × region × application type, event-driven milestones and replanning triggers. Deadlines only where an authority has published them.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #E6E2C8;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1B4D8F;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#12140A;margin-bottom:5px\"\u003e16 · Regulatory intelligence procedure for the M series\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#626150\"\u003eHow the official sources are monitored — ICH, EMA, FDA, PMDA, Health Canada, Swissmedic, MHRA — and how an event becomes an impact assessment. Official sources only; the frequency is the company's decision.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #E6E2C8;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1B4D8F;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#12140A;margin-bottom:5px\"\u003e17 · Pre-submission dossier review kit\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#626150\"\u003eA mock review of the frozen dossier before submission: questions anchored to the text, expected evidence, red flags, minutes and sign-off. No invented deficiency statistics.\u003c\/div\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c!-- BLOCK:usecases --\u003e\n\u003ch3 style=\"font-size:22px;margin:0 0 14px 0;color:#12140A\"\u003eYou can use it from tomorrow morning\u003c\/h3\u003e\n\u003ctable style=\"width:100%;border-collapse:collapse;font-size:14.5px;margin-bottom:28px\"\u003e\u003ctr style=\"background:#12140A;color:#fff\"\u003e\u003cth style=\"text-align:left;padding:11px 13px\"\u003eThe situation\u003c\/th\u003e\u003cth style=\"text-align:left;padding:11px 13px\"\u003eWhat you use\u003c\/th\u003e\u003c\/tr\u003e\u003ctr style=\"background:#FAF8EE\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E6E2C8\"\u003eWe have to decide whether the next centralised MAA goes out in eCTD v4.0\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E6E2C8\"\u003eChapters 11, 12 and 26 + Tools 03 and 15: in the EU, v4.0 is optional from 22\/12\/2025 for new centralised MAAs only, strongly recommended from Q1 2027, mandatory from Q1 2028 for new CAP MAAs only. The Chapter 12 decision tree answers v3.2.2 or v4.0 for the next submission\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E6E2C8\"\u003eThe project plan says “FDA: eCTD v4.0 mandatory from 2029”\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E6E2C8\"\u003eChapter 12 + Tool 01: FDA has accepted v4.0 since 16\/09\/2024 for new NDAs, BLAs, ANDAs, INDs and master files, but has not published a mandatory date; 2029 appears only in the ICH regional implementation table (August 2026)\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#FAF8EE\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E6E2C8\"\u003eWe also file in Japan\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E6E2C8\"\u003eChapters 12 and 24: for new applications filed from April 2026, PMDA accepts eCTD v4.0 only (PMDA slides of 28\/11\/2025, “planned”); no later PMDA notice confirming it could be found\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E6E2C8\"\u003eThe QOS and Module 3 do not say the same thing\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E6E2C8\"\u003eChapters 7, 8 and 14 + Tools 06 and 13: the cross-module consistency register and the QOS template under M4Q(R1), which normally should not exceed 40 pages of text excluding tables and figures (80 for biotech products and complex processes)\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#FAF8EE\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E6E2C8\"\u003eWe are asked how we are preparing for M4Q(R2)\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E6E2C8\"\u003eChapter 10 + Tool 07: M4Q(R2) is a DRAFT (Step 2, 14 May 2025; Step 4 planned for June 2027); in the EU and the US, M4Q(R1) applies. Readiness in weeks relative to Step 4, not early compliance\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E6E2C8\"\u003eOur bioequivalence study cites M13A and nothing else\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E6E2C8\"\u003eChapter 16 + Tool 08: M13A supersedes only the applicable parts of the EMA bioequivalence guideline (\u003ccode\u003eCPMP\/EWP\/QWP\/1401\/98 Rev. 1\u003c\/code\u003e), which otherwise remains in force; its Appendix III had already been superseded by M9 from 30\/07\/2020\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#FAF8EE\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E6E2C8\"\u003eOur SOPs cite \u003ccode\u003eCPMP\/ICH\/2887\/99\u003c\/code\u003e as if that were enough\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E6E2C8\"\u003eChapter 1 + Tool 16: the same code is shared by M4, M4Q, M4S and M4E. The fixed-field citation line — title, code, Step, effective date, status, verification date — still holds when the status changes\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E6E2C8\"\u003eThe submission goes out in two weeks\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E6E2C8\"\u003eChapters 25 and 27 + Tools 17 and 09: five families of deficiencies, each anchored to a text, four case studies and 25 questions an agency may ask, with expected evidence and red flags\u003c\/td\u003e\u003c\/tr\u003e\u003c\/table\u003e\n\u003c!-- BLOCK:rigour --\u003e\n\u003cdiv style=\"background:#FAF8EE;border-left:4px solid #8F7E24;border-radius:0 9px 9px 0;padding:20px 22px;margin-bottom:28px\"\u003e\n\u003cdiv style=\"font-weight:700;color:#5C5214;font-size:16px;margin-bottom:11px\"\u003eWhy a date in the ICH table is not a deadline\u003c\/div\u003e\n\u003cdiv style=\"font-size:14.5px;color:#1A1C10\"\u003e\n\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong style=\"color:#5C5214\"\u003eOne ICH specification, five calendars.\u003c\/strong\u003e ICH Step 4 for eCTD v4.0 dates from 10\/12\/2015 and creates no obligation: each region sets its own. In the EU, v4.0 is optional from \u003cstrong\u003e22\/12\/2025\u003c\/strong\u003e for new centralised MAAs only, strongly recommended from \u003cstrong\u003eQ1 2027\u003c\/strong\u003e, and mandatory from \u003cstrong\u003eQ1 2028\u003c\/strong\u003e for new CAP MAAs only; for MRP, DCP and national procedures EMA has published no date, and v3.2.2 continues to be accepted. In the US, FDA has accepted v4.0 since \u003cstrong\u003e16\/09\/2024\u003c\/strong\u003e and has not published a mandatory date: 2029 appears only in the ICH regional implementation table. In Japan, new applications from April 2026 are v4.0 only according to the PMDA slides, which say “planned”. EMA has not fixed the exact day within Q1 2027 or Q1 2028, and the guide does not calculate one.\u003c\/p\u003e\n\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong style=\"color:#5C5214\"\u003eThe CTD is law in the EU; the rest of the M series is guidance, with a precise burden.\u003c\/strong\u003e Annex I to Directive 2001\/83\/EC, as introduced by Directive 2003\/63\/EC, requires the dossier in five modules for every type of marketing authorisation application, irrespective of the procedure. Scientific guidelines have no legal force, but any deviation has to be fully justified in the application at the time of submission. In the US the CTD comes in through the eCTD door: the obligation stems from section 745A(a) of the FD\u0026amp;C Act, with the dates of 05\/05\/2017 and 05\/05\/2018.\u003c\/p\u003e\n\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong style=\"color:#5C5214\"\u003eStep 4 is not entry into force.\u003c\/strong\u003e M15 reached Step 4 on 29\/01\/2026 and applies in the EU from 23\/07\/2026; M13A reached Step 4 on 23\/07\/2024, applies in the EU from 25\/01\/2025 and was implemented in Canada on 27\/12\/2025. In 2026 three M guidelines became applicable in the EU: M14 from 18\/03\/2026, M11 from 11\/06\/2026, M15 from 23\/07\/2026. And M13A does not replace the EMA bioequivalence guideline: it supersedes only its applicable parts.\u003c\/p\u003e\n\u003cp style=\"margin:0 0 0 0\"\u003e\u003cstrong style=\"color:#5C5214\"\u003eNo date, code or figure without a source.\u003c\/strong\u003e Nine labels in two families state, at every citation, the status of the document (current, not yet applicable with its date, draft, in development, superseded) and the nature of the statement (requirement, guidance, good practice, GuideGxP editorial work). Verification cut-off \u003cstrong\u003e23 September 2026\u003c\/strong\u003e, a register of \u003cstrong\u003e195 sources\u003c\/strong\u003e with URL and access date, \u003cstrong\u003e147 decisions\u003c\/strong\u003e tracked with who decides and where it is recorded. No statistics on dossier deficiencies: none of the official sources read publishes any, and the guide says so.\u003c\/p\u003e\n\u003c\/div\u003e\u003c\/div\u003e\n\u003c!-- BLOCK:contents --\u003e\n\u003ch3 style=\"font-size:22px;margin:0 0 12px 0;color:#12140A\"\u003eInside the guide\u003c\/h3\u003e\n\u003cdiv style=\"font-size:15px;color:#1A1C10;margin-bottom:28px\"\u003e\n\u003cp style=\"margin:0 0 9px 0\"\u003e\u003cstrong style=\"color:#12140A\"\u003ePart I — The M series and its legal force (Chapters 1–4).\u003c\/strong\u003e How to read the guide, with the nine labels and five reading paths by function; the M-series calendar from 2000 to 2030; the ICH Steps and the jurisdiction rule; the inventory from M1 to M18, with the status of each text and what does not exist (M5 stopped at Step 2, there is no M17).\u003c\/p\u003e\n\u003cp style=\"margin:0 0 9px 0\"\u003e\u003cstrong style=\"color:#12140A\"\u003ePart II — The CTD (Chapters 5–10).\u003c\/strong\u003e M4(R4), the organisation of the CTD and granularity; the regional Module 1 compared across the EU, the US, Japan, Canada and the UK, for format only; Module 2 with the QOS, overviews and summaries; Module 3 under M4Q(R1); Modules 4 and 5 with section numbers checked against the guidelines; M4Q(R2) as readiness, not compliance.\u003c\/p\u003e\n\u003cp style=\"margin:0 0 9px 0\"\u003e\u003cstrong style=\"color:#12140A\"\u003ePart III — The eCTD (Chapters 11–14).\u003c\/strong\u003e From v3.2.2 to v4.0, with the technical differences read only from ICH and FDA sources; the five regional calendars and the decision tree for the next submission; publishing in practice: leaf titles, lifecycle, sequence planning, technical validation and QC; dossier governance, from the core dossier to cross-module consistency.\u003c\/p\u003e\n\u003cp style=\"margin:0 0 9px 0\"\u003e\u003cstrong style=\"color:#12140A\"\u003ePart IV — The scientific guidelines (Chapters 15–21).\u003c\/strong\u003e M3(R2) and the timing of clinical development; the M9, M13A, M13B and M13C bioequivalence cluster, with a decision tree on which text governs; M10 for bioanalytical method validation; M12 for drug interactions; M7(R2) in brief and M14; M11 and M15; the topics in development — M16, M18, the M7 nitrosamine addendum — and how to monitor them.\u003c\/p\u003e\n\u003cp style=\"margin:0 0 9px 0\"\u003e\u003cstrong style=\"color:#12140A\"\u003ePart V — The jurisdictions (Chapters 22–24).\u003c\/strong\u003e The European Union and the United Kingdom; the United States; Japan, Canada, Switzerland, Brazil and China, with the verified implementing instrument, the gaps declared where verification was not possible, and the comparative table.\u003c\/p\u003e\n\u003cp style=\"margin:0 0 9px 0\"\u003e\u003cstrong style=\"color:#12140A\"\u003ePart VI — Readiness and verification (Chapters 25–27).\u003c\/strong\u003e Recurring dossier deficiencies in five families, each anchored to a text; the dossier gap assessment and the eCTD v4.0 transition plan with event-driven milestones; four case studies in the format problem → risk → decision → activities → documentation → evidence → outcome, and 25 questions an agency may ask, with expected evidence and red flags.\u003c\/p\u003e\n\u003cp style=\"margin:0 0 9px 0\"\u003e\u003cstrong style=\"color:#12140A\"\u003ePlus 5 appendices.\u003c\/strong\u003e The register of \u003cstrong\u003e195 sources\u003c\/strong\u003e with URL and access date; the status matrix by jurisdiction; the \u003cstrong\u003e147 decisions\u003c\/strong\u003e, each with who decides, on what basis and where it is recorded; the cards for the 17 tools; the glossary.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c!-- BLOCK:preview --\u003e\n\u003cdiv style=\"background:#FAF8EE;border:1px solid #E6E2C8;border-radius:12px;padding:22px 24px;margin-bottom:28px\"\u003e\n\u003ch3 style=\"font-size:22px;margin:0 0 8px 0;color:#12140A\"\u003eRead the extract before you buy\u003c\/h3\u003e\n\u003cp style=\"margin:0 0 16px 0;font-size:15px;color:#626150;max-width:720px\"\u003eThe free extract is made of real pages from the book, not a sales summary: 20 pages in the English edition, 19 in the Italian. It contains the regulatory status box with the dates to note, the full table of contents with the real page numbers, the five eCTD calendars table from Chapter 12, a complete case study from Chapter 27 — the same method change handled in eCTD v3.2.2 in the EU and in v4.0 in the US — and the list of the 17 tools.\u003c\/p\u003e\n\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:10px\"\u003e\n\u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/GuideGxP_ICH_M_2ed_Preview_ITA.pdf?v=1790205495\" target=\"_blank\" rel=\"noopener\" style=\"display:inline-block;background:#D4C35A;color:#12140A;font-weight:700;font-size:15px;text-decoration:none;padding:12px 22px;border-radius:6px\"\u003eFree extract — Italian edition (PDF)\u003c\/a\u003e\n\u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/GuideGxP_ICH_M_2ed_Preview_ENG.pdf?v=1790205495\" target=\"_blank\" rel=\"noopener\" style=\"display:inline-block;background:#ffffff;color:#12140A;border:1.5px solid #12140A;font-weight:700;font-size:15px;text-decoration:none;padding:11px 21px;border-radius:6px\"\u003eFree extract — English edition (PDF)\u003c\/a\u003e\n\u003c\/div\u003e\u003c\/div\u003e\n\u003c!-- BLOCK:specs --\u003e\n\u003ch3 style=\"font-size:22px;margin:0 0 14px 0;color:#12140A\"\u003eSpecifications\u003c\/h3\u003e\n\u003ctable style=\"width:100%;border-collapse:collapse;font-size:14.5px;margin-bottom:24px\"\u003e\u003ctr style=\"background:#FAF8EE\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8;width:34%;font-weight:600;color:#12140A\"\u003eFormat\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8\"\u003eA4 PDF — 259 pages (ITA edition) · 261 pages (ENG edition)\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8;width:34%;font-weight:600;color:#12140A\"\u003eEdition\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8\"\u003eSecond edition · September 2026 · version 2.0. Rewritten from scratch; supersedes the first edition.\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#FAF8EE\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8;width:34%;font-weight:600;color:#12140A\"\u003eStructure\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8\"\u003e27 chapters in six parts + 5 appendices\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8;width:34%;font-weight:600;color:#12140A\"\u003eScope\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8\"\u003eThe ICH M series from M1 to M18: the CTD (M4), eCTD v3.2.2 and v4.0 (M8, M2), the scientific guidelines (M3, M7, M9 to M15), the topics in development. The dossier: content, format, eCTD and technical lifecycle.\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#FAF8EE\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8;width:34%;font-weight:600;color:#12140A\"\u003eOut of scope\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8\"\u003eAuthorisation procedures, variations, renewals and dealings with the authorities (GuideGxP Regulatory Affairs guide); stability and the content of Q8–Q14 (ICH Q guide); mutagenic impurities and nitrosamines (Q3D + M7 guide).\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8;width:34%;font-weight:600;color:#12140A\"\u003eJurisdictions covered\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8\"\u003eEuropean Union, United Kingdom, United States, Japan, Canada, Switzerland, Brazil and China\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#FAF8EE\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8;width:34%;font-weight:600;color:#12140A\"\u003eToolkit\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8\"\u003e17 editable tools per edition: 10 Excel workbooks and 7 Word documents\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8;width:34%;font-weight:600;color:#12140A\"\u003eLanguages\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8\"\u003eThe guide and the toolkit exist as an Italian edition and as an English edition, identical in structure: choose the \u003cstrong\u003eITA - Italiano\u003c\/strong\u003e or the \u003cstrong\u003eENG - English\u003c\/strong\u003e variant.\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#FAF8EE\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8;width:34%;font-weight:600;color:#12140A\"\u003eSources\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8\"\u003eRegister of 195 official sources, with issuing body, title, code, version, status, URL and access date\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8;width:34%;font-weight:600;color:#12140A\"\u003eDecisions\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8\"\u003e147 decisions tracked: what is decided, who decides, on what basis, where it is recorded\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#FAF8EE\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8;width:34%;font-weight:600;color:#12140A\"\u003eRegulatory cut-off\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8\"\u003e23 September 2026\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8;width:34%;font-weight:600;color:#12140A\"\u003eFree preview\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8\"\u003e19 pages (ITA edition) · 20 pages (ENG edition)\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#FAF8EE\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8;width:34%;font-weight:600;color:#12140A\"\u003ePrice\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8\"\u003e€129.00\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8;width:34%;font-weight:600;color:#12140A\"\u003eDelivery and licence\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E6E2C8\"\u003eImmediate download after purchase. Individual use, internal to the purchasing company. Digital product: no physical shipment.\u003c\/td\u003e\u003c\/tr\u003e\u003c\/table\u003e\n\u003c!-- BLOCK:audience --\u003e\n\u003cdiv style=\"background:#FAF8EE;border:1px solid #E6E2C8;border-radius:11px;padding:18px 21px;margin-bottom:24px;font-size:14.5px;color:#1A1C10\"\u003e\n\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong style=\"color:#12140A\"\u003eWho it is for.\u003c\/strong\u003e Regulatory Affairs and Regulatory Operations, eCTD publishing, Regulatory Intelligence, CMC and Module 3 authors, nonclinical and clinical authors, clinical pharmacology and generics development, QA reviewing the dossier before submission, consultants. It is written for people who \u003cstrong\u003eprepare, publish or review a dossier\u003c\/strong\u003e and need to know which text governs a section, in which version, with what force and from when: it does not explain what a medicinal product or a marketing authorisation application is.\u003c\/p\u003e\n\u003cp style=\"margin:0\"\u003e\u003cstrong style=\"color:#12140A\"\u003eWho it is not for.\u003c\/strong\u003e It is not the Regulatory Affairs guide: EU authorisation procedures (centralised, MRP, DCP, national), the variations regulation, renewals, the sunset clause and assessment timelines are out of scope. It is not the ICH Q guide, nor the Q3D + M7 guide. It does not reproduce the text of the guidelines, which you should keep at hand. And it is not legal advice: its readings of legal force are interpretations based on the sources cited, not opinions.\u003c\/p\u003e\u003c\/div\u003e\n\u003c!-- BLOCK:expert --\u003e\n\u003cdiv style=\"background:#12140A;border-radius:12px;padding:24px 26px;color:#fff;margin-bottom:20px\"\u003e\n\u003cdiv style=\"font-size:18px;font-weight:700;margin-bottom:8px;color:#ffffff\"\u003eDo you have to decide whether and when to move to eCTD v4.0, or defend a dossier choice in front of an agency?\u003c\/div\u003e\n\u003cdiv style=\"font-size:15px;color:#F3F0D8;margin-bottom:16px;max-width:660px\"\u003eDescribe your portfolio, the regions you file in and the point where you are stuck. GuideGxP will assess the request and, where appropriate, may put you in touch with a specialist matched to your technical needs and your geographical area.\u003c\/div\u003e\n\u003ca href=\"https:\/\/www.guidegxp.com\/pages\/expert-support?area=other\u0026amp;source=product-ichm-guide\u0026amp;cta=product-page\" style=\"display:inline-block;background:#D4C35A;color:#12140A;font-weight:700;font-size:15px;text-decoration:none;padding:11px 22px;border-radius:6px\"\u003eDescribe your situation →\u003c\/a\u003e\n\u003cdiv style=\"font-size:12.5px;color:#F3F0D8;opacity:.75;margin-top:12px\"\u003eNo obligation to buy. Every request is assessed before any referral to a specialist.\u003c\/div\u003e\u003c\/div\u003e\n\u003c!-- BLOCK:disclaimer --\u003e\n\u003cp style=\"font-size:12.5px;color:#626150;margin:0\"\u003eGuideGxP guides do not replace the official regulations (ICH, European Commission, EMA, FDA, MHLW\/PMDA, Health Canada, Swissmedic, MHRA, Anvisa, NMPA): they are operational support tools, and the user remains responsible for the correct application of the regulations in force in their own company context. The official texts of the ICH M guidelines and of the eCTD specifications are freely available and should be kept at hand while reading: this guide does not replace them. The regulatory status described is the one verified on 23\/09\/2026: applicability dates, the status of draft documents — M4Q(R2) in particular — and the version of the eCTD v4.0 Implementation Guide accepted by each authority must be rechecked before use. ICH guidelines have no legal force in themselves: binding force comes from regional implementation, which this guide states jurisdiction by jurisdiction. Digital product: no physical shipment.\u003c\/p\u003e\n\u003c\/div\u003e","brand":"GuideGxP","offers":[{"title":"ENG - English","offer_id":53449462776138,"sku":null,"price":129.0,"currency_code":"EUR","in_stock":true},{"title":"ITA - Italiano","offer_id":53449462808906,"sku":null,"price":129.0,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/00_cover_3D_caad950f-59da-43a6-8a03-b4cf72fb94bd.png?v=1790359033","url":"https:\/\/www.guidegxp.com\/products\/ich-m-ctd-dossier-ectd-v4-operational-guide","provider":"GuideGxP","version":"1.0","type":"link"}