Published Paper Details:

The Common Technical Document (CTD) was introduced to streamline the drug registration process over many countries, including the US, EU, and Japan, by standardizing the structure and content of regulatory dossiers. The aim of this strategy is to reduce the time, resources, and complexity required for pharmaceutical industries to secure marketing authorization in many nations. quality control, resource constraints, and language barriers continue to impact the execution of CTD, particularly in developing countries like India. The Common Technical Document (CTD) was introduced to streamline the drug registration process over many countries, including the US, EU, and Japan, by standardizing the structure and content of regulatory dossiers. the aim of this strategy is to reduce the time, resources, and complexity required for pharmaceutical industries to secure marketing authorization in many nations. quality control, resource constraints, and language barriers continue to impact the execution of CTD, particularly in developing countries like India. administrative data, technical summaries, quality data, non-clinical study reports, and clinical study reports are all covered in the five modules in which CTD is divided. The adoption of the CTD facilitates faster regulatory reviews, improved communication between regulatory bodies, and the potential for electronic submissions. in spite these Benefit, challenges such as regulatory harmonization issues, the volume and difficulty of data, quality control, resource constraints, and language barriers continue to impact the implementation of CTD, particularly in developing countries like India. This article explores the structure, advantages, challenges, and limitations of the CTD, offering insights into its global impact and the hurdles faced by the pharmaceutical industry in regulatory submissions.