A closer look into the eCTD triangle and its modules

CTD is a well known term in the Life Sciences industry, and stands for Common Technical Document. This internationally agreed format contains a set of specifications developed by the European Medicines Agency (EMA), the Food and Drug Administration (FDA) and the Ministry of Health, Labour and Welfare.

What is the eCTD?

It is used for the preparation of applications for new drugs that need to be submitted to the regional regulatory authorities in all participating countries across Europe, Japan and the United States.

 

The paper CTD is destined to be replaced by the electronic version, called eCTD, and makes regulatory review processes easier.

The five modules

The CTD is organized into five modules. Module 1 is region specific and modules 2, 3, 4 and 5 are intended to be common for all regions.

Module 1

Module 1 is not part of the CTD and contains administrative information and prescribing information that is region specific. These documents can be forms, cover letters, labels, brochures, etc.

Module 2

Module 2 consists of the CTD summaries and starts with an introduction to the specific drug, its pharmacological class, mode of action and proposed clinical use. It should also provide an overall summary of the quality information that is provided, the (non)-clinical overview, as well as the (non)-clinical summary

Module 3

Module 3 is the quality of the pharmaceutical documentation. For example, everything from the drug substance information (name, manufacturer), to the drug product information (name, dosage form, formula, …).

Module 4

Module 4 consists of the non-clinical study reports like pharmacology and toxicology.

Module 5

Module 5 contains clinical study reports, like clinical trials.

How can DocShifter help you?

Are you a pharmaceutical or biotech company and are your interested in drastically improving your eCTD publishing solutions ?

DocShifter offers a Hi-Fidelity module which creates fully compliant submission ready documents. Documents ready to be fed into any publishing solution you are using, while allowing QC steps to be performed earlier in the process.

Learn more about the Hi-Fidelity module by contacting us via hello@docshifter.com and one of our experts will set up a time to talk about your particular compliance issues.