The structure and format of applications to be submitted to regulatory authorities in the USA, Europe, and Japan has been defined within the International Conference on Harmonisation (ICH).
Common Technical Document
The CTD describes the organization of modules, sections and documents to be used by applicants for marketing authorizations , according to the ICH of Technical Requirements for Registration of Pharmaceuticals for Human Use.
The Common Technical Document is composed of five modules:
- Administrative and prescribing information (regional module)
- Overview and summary of modules 3 to 5
- Quality (pharmaceutical documentation)
- Nonclinical (Pharmacology/Toxicology)
- Clinical – efficacy (Clinical Trials)
Electronic Common Technical Document – eCTD
The eCTD is an interface for industry-to-agency transfers of regulatory information while at the same time facilitating the creation, review, lifecycle management and archival of electronic submissions.
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