Common Technical Document

The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of medicine, designed for use across Europe, Japan, the United States, and beyond.

[1] The CTD is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries.

[1] The CTD is maintained by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

[1][2] After the United States, European Union and Japan, the CTD was adopted by several other countries including Canada[3] and Switzerland.

However, investigational new drugs meant for emergency use or treatment applications and not for commercial distribution are not subject to the CTD requirements.