eCTD
The Electronic Common Technical Document (eCTD) is an interface definition for the electronic transmission of information from a drug manufacturer to the competent authorities for the purpose of drug approval . In terms of content, the standard is based on the definitions of the Common Technical Document (CTD).
The eCTD standard was developed by ICH , working group M2.
content
In terms of content, an eCTD consists of five modules
- Module 1: Administrative information and prescribing information
- Module 2: Summaries
- Module 3: Quality
- Module 4: Non-clinical study reports
- Module 5: Clinical Study Reports
Module 1 contains country and region-specific information and is prescribed by the relevant competent authority, e.g. B. EMA for Europe, FDA for USA, Health Canada for Canada, Japanese Ministry of Health for Japan and Swissmedic for Switzerland. Modules 2–5 are internationally standardized. This makes it possible to standardize the submission and processing of drug approval applications worldwide.
Data structure
An eCTD consists of individual documents in a folder structure. The naming of documents and folders is specified by the eCTD specification, as are formatting rules.
Furthermore, an XML file is attached to the structure at the lowest folder level, which contains the logical structure of the documents and - in the case of subsequent submissions and change requests - the information which new or replaced documents are contained. This enables the database of pharmaceutical manufacturers and the relevant authorities to remain synchronized.