Electronic common technical document

The Electronic Common Technical Document ( eCTD ) is an interface definition for the electronic transmission of information of a drug manufacturer to competent authorities for the purpose of drug approval. Content of the standard is based on the definitions of the Common Technical Document ( CTD).

It was developed by the ICH eCTD standard, workgroup M2.

Content

Content consists of five modules an eCTD

  • Module 1: Administrative Information and Prescribing Information
  • Module 2: Summaries ( Summaries )
  • Module 3: Quality
  • Module 4: Non-clinical study reports
  • Module 5: Clinical Study Reports

Module 1 provides country-and region-specific information, and is prescribed by the appropriate authority, such as EMA for Europe, FDA for USA, Canada Health for Canada, Japanese Ministry of Health of Japan and Swissmedic for Switzerland. The modules 2-5 are internationally standardized. This makes it possible to unify the submission and processing of applications for authorization of medicines worldwide.

Data structure

A eCTD consists of individual documents in a folder structure. Naming of documents and folders are specified by the eCTD specification, as well as formatting rules.

Furthermore, the structure at the lowest folder level is accompanied by an XML file that contains the logical structure of documents as well - at Nacheinreichungen and amendments - the information that new or replaced documents are included. This makes it possible that the database remains synchronized with drug manufacturers and the relevant authority.

Regulation of therapeutic goods International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
253207
de