This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.
Common Technical Document (CTD)
Common Technical Document (CTD)
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.