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.
Always verify against the current published text before relying on it for a submission or inspection.
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.
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.
ICH M4(R4): frequently asked questions
Quick answers to common questions about ICH M4(R4).
What is ICH M4(R4)?
ICH M4(R4) — Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use — is a guideline issued by the International Council for Harmonisation. 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.
Who does ICH M4(R4) apply to?
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.
What are the key requirements of ICH M4(R4)?
ICH M4(R4) requires, among other things: 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.
When was ICH M4(R4) last updated?
The current version of ICH M4(R4) dates from June 2016.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.