The Common Technical Document is divided into 5 Modules :
Detailed subheadings for each Module are specified for all jurisdictions. The contents of Module 1 and certain subheadings of other Modules will differ, based on national requirements.
After USA, European Union and Japan, the CTD has been adopted by several other countries including Canada and Switzerland.
The Paper CTD is destined to be replaced by its electronic counterpart, the eCTD.
The electronic common technical document: transition to a new paradigm in regulatory submissions. (Application Area).
Jan 01, 2003; Since 1990, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human...
Publishing Software validates Common Technical Document submissions.(GlobalSubmit 2010 Now Available: Expands Product Suite with New PUBLISH(TM) and CROSSCHECK(TM) Functionality)
Jan 21, 2011; Designed to publish, validate, and review electronic Common Technical Document global submissions, GlobalSubmit 2010 helps keep...