Common Technical Document (CTD) | The Global Language of Pharmaceutical Submissions

The Common Technical Document (CTD) is one of the most significant harmonisation achievements in global regulatory science. Before CTD, every country required dossiers in different formats, leading to duplication, rework and delays in approvals. With the adoption of CTD, a single, harmonised structure now guides how quality, clinical and non-clinical data are organised for submission across the US, EU, UK, Japan, Canada, Australia and most ROW markets.

At its core, CTD enables regulatory authorities to review data efficiently and allows organisations to streamline development, dossier preparation and lifecycle management.

Below is a deeper look at each of the five modules and why they matter.

Module 1 – Regional Administrative Information

This is the only non-harmonised section. It contains country-specific forms, fees, declarations, product labelling, prescribing information, country-specific requirements and legal certifications. While the scientific data may remain unchanged, regulatory teams must tailor this module for each target market.

Module 2 – Overviews and Summaries

Module 2 bridges the gap between detailed scientific data and the reviewer’s understanding. It includes the Quality Overall Summary (QOS), which condenses the entire CMC development story into a concise narrative. It also includes non-clinical and clinical overviews and summaries. Well-written Module 2 documents often determine how smoothly the assessment proceeds, as they highlight key risks, justifications and the scientific rationale for product development decisions.

Module 3 – Quality (CMC)

Module 3 is the backbone of pharmaceutical development submissions. It documents the pharmaceutical development process, including formulation rationale, excipient selection, functional attributes, manufacturing process design, control strategy and stability data. Within Module 3, section P.2 (Pharmaceutical Development) has evolved significantly with the adoption of QbD principles, incorporating risk assessment, multivariate studies, design space concepts and evidence-based process understanding. For generic products, strong Module 3 documentation is crucial for smoother approvals and fewer regulatory queries.

Module 4 – Non-Clinical (Toxicology)

This module captures pharmacology, safety pharmacology and toxicology data, largely generated through animal studies. For generic submissions, the module typically depends on literature references and historical data because the safety profile of the reference drug is already well established.

Module 5 – Clinical

Module 5 includes all human data: bioavailability studies, bioequivalence trials, comparative clinical studies where applicable, protocols, statistical analyses, and consolidated clinical summaries. For generics, the bioequivalence report is the most critical component.

Resource Person: Moinuddin Syed. Ph.D, PMP®