What does CTD stand for in regulatory submission?

The term CTD stands for Common Technical Document, which is a standardized format for the submission of regulatory information for new drugs and biologics. The CTD is recognized internationally and is designed to facilitate the regulatory review process by providing a consistent framework for presenting data. It is organized into five modules, which include quality, safety, efficacy, administrative information, and summary data. This standardization significantly eases the process for both regulators and applicants, allowing for more efficient reviews and promoting a harmonized approach to drug development across different regions.

The other terms in the options—like Common Technical Data, Common Test Dossier, and Comprehensive Technical Disclosure—do not accurately describe the established regulatory framework or submission format recognized by authorities such as the FDA and EMA. As a result, they do not capture the essence of what the CTD represents in the context of regulatory submissions.