BEYOND THE SURFACE: A DEEP DIVE INTO CTD AND ECTD PROTOCOL DYNAMICS

Kadam Shruti Sunil*, Rajpure Pranjal Madhukar, Devade Omkar Ashok and V. K. Redasani

ABSTRACT

The Common Technical Document (CTD) was developed to establish a standardized format across Europe, the USA, and Japan for the technical documentation required in applications for human pharmaceutical product registration. It comprises five main modules: Module 1 covers administrative and prescribing information, Module 2 includes overviews and summaries of Modules 3–5, Module 3 focuses on quality with pharmaceutical documentation, Module 4 contains non-clinical reports on pharmacology and toxicology, and Module 5 encompasses clinical study reports from clinical trials. Detailed guidelines outline the content for each module, and adherence to the CTD format is now mandatory for the majority of submission dossiers.

Keywords: CTD, eCTD, Modules, Summary, Regulatory.