CTD

Origin

The CTD structure was developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in the late 1990s to harmonize the drug registration requirements across the European Union, Japan, and the United States. This harmonization effort aimed to reduce the time and resources needed to compile submissions for multiple regulatory bodies.

Mechanism

The document is organized into five modules, ranging from regional administrative information (Module 1) to the critical Quality (CMC), Non-clinical (safety), and Clinical (efficacy) data (Modules 3, 4, and 5). By standardizing the location of key scientific data, such as pharmacokinetic and pharmacodynamic results for a hormone, the CTD allows regulatory reviewers to efficiently access and evaluate the totality of evidence supporting the product’s quality and therapeutic benefit.