Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use
Defines the Common Technical Document — the five-module structure in which a marketing application is organised for the ICH regions. Module 1 is regional; Modules 2 to 5 are common, covering summaries, quality, nonclinical study reports and clinical study reports.
What this does not cover
stated in the document's own scope- It sets format, not data requirements: it does not say which studies are needed.
- Module 1 content is defined regionally, not by M4.
- Applicants should not change the overall CTD organisation, though they may adapt individual formats in the nonclinical and clinical summaries.
- Electronic transport of the dossier is defined by ICH M8, not by M4.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
ICH M4 defines the Common Technical Document, the agreed format for organising the registration dossier of a human medicine so that it is acceptable to regulators in all ICH regions. It organises the dossier into five modules: Module 1, administrative and prescribing information, which each region specifies; and Modules 2 to 5, which are common — summaries, quality, nonclinical study reports and clinical study reports. Companion guidelines M4Q, M4S and M4E set the content of the quality, safety and efficacy parts. A common format reduces the time to compile applications and eases electronic submission.
Scope & applicability
The organisation of a registration dossier, not its scientific content: M4 says where information goes and in what order, while M4Q(R1), M4S(R2) and M4E(R2) say what the quality, safety and efficacy content should contain. It is a format agreement, which is precisely what makes a submission plan possible across regions.
Legal basis & how it acquires force
An ICH harmonised guideline at Step 4. It acquires force when regulators adopt it: the ICH regulatory members implement the CTD format in their own submission requirements. The current version is M4(R4), approved on 15 June 2016, which corrected the revised Granularity Document annex. The guideline itself states that it is not intended to indicate what studies are required, only an appropriate format for the data acquired.
Document structure
| Part | Covers |
|---|---|
| Module 1 — Administrative and prescribing information | Region-specific documents such as application forms and proposed labelling, specified by each authority |
| Module 2 — CTD summaries | Table of contents, introduction, Quality Overall Summary, Nonclinical and Clinical Overviews, Nonclinical Written and Tabulated Summaries, and Clinical Summary |
| Module 3 — Quality | Organised according to M4Q |
| Module 4 — Nonclinical study reports | Organised according to M4S |
| Module 5 — Clinical study reports | Organised according to M4E |
| Annex — Granularity Document | How documents are divided and paginated within the dossier |
Key requirements
- Module 1 — regional administrative information, outside the scope of the common structure
- Module 2 — the summaries: Quality Overall Summary, Nonclinical Overview and Summaries, Clinical Overview and Summary
- Module 3 — quality; Module 4 — nonclinical study reports; Module 5 — clinical study reports
- Consistent numbering and granularity so a reviewer can locate content across applications
Implementation tips
- Plan the dossier by dependency, not by document count: a late study report in Module 5 silently blocks the Module 2 summary that must describe it
- Module 2 is written from Modules 3 to 5 and is where inconsistency between functions becomes visible to a reviewer — schedule it as an integration activity, not a summary-writing task
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
The CTD is the content structure; ICH M8 defines the electronic Common Technical Document that carries it in machine-processable form. M4Q, M4S and M4E define the content of Modules 2 to 5 for quality, safety and efficacy. Regional authorities define Module 1.
ICH M4(R4): frequently asked questions
Quick answers to common questions about ICH M4(R4).
Which module of the CTD is not harmonised?
Module 1, administrative information and prescribing information, which is region-specific. Modules 2, 3, 4 and 5 are intended to be common for all regions.
What is the current version of ICH M4?
M4(R4), approved by the ICH Assembly on 15 June 2016, which adopted corrections to the revised Granularity Document annex.
Does the CTD tell an applicant what studies to run?
No. The guideline states that it is not intended to indicate what studies are required; it indicates an appropriate format for the data that have been acquired.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.