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ICH guideline M4 (R4) on common technical document (CTD) for the

What is M4 in ICH guidelines?
M4 : The Common Technical Document
For industries, it has eliminated the need to reformat the information for submission to the different ICH regulatory authorities.
The CTD is organised into five modules.
Module 1 is region specific and Modules 2, 3, 4 and 5 are intended to be common for all regions.
What is the purpose of CTD?
The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States and beyond.
Which documents are part of the CTD dossier?
The CTD dossier is divided into five main modules: Module 1 – Administrative information and prescribing information; Module 2 – Overviews and summaries of Modules 3–5; Module 3 – Quality (pharma- ceutical documentation); Module 4: Non-clinical reports (pharmacology/toxicology); Module 5: Clinical study reports (
The CTD: determines the appropriate format to assemble all the Quality, Safety and Efficacy information required. describes the organisation of modules, sections and documents to be used in a regulatory dossier.

ICH M4(R4) Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use. Content: This guideline presents the common format for the preparation of a well-structured Common Technical Document for applications that will be submitted to regulatory authorities.

ICH guideline M4 (R4) on common technical document (CTD) for the

What is M4 in ICH guidelines?

What is the purpose of CTD?

Which documents are part of the CTD dossier?