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M4 common technical dossier

Published on March 31, 2026   17 min

A selection of talks on Pharmaceutical Sciences

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0:00
Hello. This is Jan Willem van der Laan. I'm retired from the Medicines Evaluation Board in the Netherlands, and I will give a talk today about the non-clinical part of the common technical dossier. I will explain more about this document.
0:24
The title of the multidisciplinary topic 4 is an early one in the ICH process, in the early 90s, we started with a common technical document to have a harmonized dossier over Europe, America, and Japan. That's important to reduce the efforts of the pharmaceutical industry in the requirements for a new dossier. It's a non-clinical approach today. However, the toxicology is hardly the topic of this part, it's more organizational. Common technical document for the registration of pharmaceuticals for human use is done on safety on the non-clinical overview and the non-clinical summaries in Module 2 and the organization of Module 4, and I will explain more in a moment.
1:20
In fact, the structure of the dossier is an overall structure of the whole dossier in a type of triangle. You see it on the screen. At the lowest level of the triangle is describing the various parts of the dossier: The quality part, the non-clinical study reports, and the clinical study reports. The middle level is Module 2. It's the summary and the overview, and I will explain the difference between overview and summary later on. In fact, the top of the triangle is not part of the common technical dossier in the sense that it is not the unharmonized description, and I will also start with that.

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M4 common technical dossier

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