common technical document

The Common Technical Document is divided into five modules:

RPS is in many ways comparable to the electronic Common Technical Document.

The content is based on the Common Technical Document (CTD) format.

Common Technical Document (CTD)

The electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information.

To make sure you have the most recent versions of the specifications referenced in this guidance please check Electronic Common Technical Document (eCTD).

Electronic Common Technical Document (eCTD) (FDA)

See Electronic Common Technical Document (eCTD) Requesting a Pre-Assigned Application number.

The ICH has developed the electronic Common Technical Document (eCTD) to promote harmonization of regulatory submissions in electronic format across various regions (United States, Europe and Japan).

The Common Technical Document (CTD) is a set of specification for application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States.

They include clinical study protocols, clinical study reports, patient informed consent forms, investigator brochures and summary documents (e.g. in Common Technical Document [CTD] format) that summarize and discuss the data a company gathers in the course of developing a medical product.

The specification is part of the evolution from the 1999 FDA electronic submission (eSub) guidance and the electronic Common Technical Document (eCTD) documents that specify a document describing the content and structure of the included data should be provided within a submission.

For example, since year 2003, the authorities in the United States, the European Union and Japan ask for the Common Technical Document (CTD) format, and more recently, its electronic version - the electronic Common Technical Document (eCTD).