The Common technical document has 5 modules and is a format set by ICH for assembling the quality, safety, and efficacy information in a common format. The CTD document was introduced to streamline the dossier submission process as the earlier process was not uniform leading to difficulties. Regulatory agencies of the US, Europe, and Japan agreed upon this CTD format set by ICH.

The CTD document is common for all three regions in which module 1 is administrative information, which is region-specific, The CTD document is appreciated for the clarity and consistency of data presentation about the quality, safety, and efficacy of the new drugs. Regulatory agencies around the world widely accept this CTD format  and it is a mandatory format for New Drug applications in the EU and Japan. in the United States, it is the most recommended format for NDA submission.

Contents of CTD – The common technical document has the following modules

• Module-1 – it contains administrative information that is region-specific.
• Module 2 contains a quality overall summary
• Module 3 contains the CMC data – quality
• Module-4 non-clinical study reports
• Module-5 Clinical Study Reports

Importance of the CTD format of dossier submission – it has streamlined the application review process and significantly reduced the time for compilation of technical data in a clear format for global registrations. It can be used for all applications like NDA, ANDA submission, BLA and also Investigational new drug applications.