When your drug is going through approval process, there are a lot of documents that you need to prepare. Different countries have different needs, each doc holds utmost importance. One small formatting error can put you back to square one. Therefore, common technical documents come in handy.
If you are in pharmaceutical development, you need to have a strong understanding of what a CTD is, what is its structure and why it is important. A good CTD gives companies a harmonized, globally accepted structure for presenting quality, safety and clinical data. US, Europe, Japan and other ICH regions rely for easy reviews.
In this guide, we break down the CTD in a simple, straightforward, practical, and easy to digest. Let’s dive into the document that keeps global drug approvals running smoothly.
What is a Common Technical Document (CTD)?
The Common Technical Document is the one format almost every major regulator actually agrees on. Think of it as the world’s most boring, but most useful, universal template for getting your drug approved.
At its core, the CTD is a harmonised structure used to submit data for marketing authorisation applications (MAA). Regulators across the ICH regions, Europe, the US, and Japan, lean on it to review a product’s quality, safety, and efficacy. The beauty of the CTD is that it forces everything into the same clean, predictable layout. Nothing fancy. Nothing chaotic. Just order.
And yes, that order is intentional. If your CTD has a good structure, authorities can easily evaluate your submissions, resulting in easy dossier understanding.
This is why CTD is important?
- To standardise drug submissions globally so companies don’t have to reinvent the wheel for every country
- To organise critical data such as quality, non-clinical, and clinical—in a single, uniform layout
- To speed up regulatory reviews by giving assessors what they need, exactly where they expect it
- To reduce duplication when submitting the same drug to multiple regions
In short, the CTD isn’t just a document. It’s a framework that keeps global drug approvals from turning into chaos. And for anyone in regulatory affairs, understanding it is not optional, it’s foundational.
Understanding the Structure of CTD
Common technical documents are pretty straightforward, there are 5 modules, and each of them serve a specific purpose for regulators to understand about your product, it’s working, if it’s safe or not etc.
Here’s how the whole thing fits together.
Module 1: Regional Administrative Information
Module states the formalities of the region you are trying to get approval at. So it stays flexible by design.
It usually includes:
- Application forms required by local authorities
- Patient Information Leaflets (PIL)
- Region-specific labelling and packaging information
You can think of Module 1 as the “local customs” section of the dossier. The rest of the CTD is universal, but this module bends to the needs of each regulatory agency.
Module 2: CTD Summaries
Module 2 is the summary of your product to give a quick summary of the entire application.
It usually contains:
- Quality Overall Summary (QOS): A high-level view of Module 3
- Nonclinical Overview & Summary: Key findings from animal and in-vitro studies
- Clinical Overview & Summary: The story behind your clinical data
Module 2 is often the first section reviewers read, so clarity matters. A good summary can make their evaluation smoother, faster, and far less painful.
Module 3: Quality
This is the most technical module, where the science meets the manufacturing floor. It explains how the drug is made, controlled, and kept stable over time.
It generally covers:
- Detailed manufacturing processes
- Specifications and analytical procedures
- Quality assurance strategies
- Stability studies for both drug substance and drug product
Think of Module 3 as the blueprint that proves your product can be manufactured consistently and safely from day one.
Module 4: Nonclinical Study Reports
Before a drug reaches humans, it goes through nonclinical testing. Module 4 captures all that data in a structured, comprehensive way.
It includes:
- Pharmacology studies
- Toxicology reports
- Pharmacokinetics (ADME data)
This module exists for one reason: to demonstrate foundational safety. Regulators must see evidence that the drug behaves predictably and acceptably in controlled environments before approving clinical trials.
Module 5: Clinical Study Reports
Module 5 is where the story gets real, human data. Everything that happened in Phase I, II, and III trials is documented here.
It contains:
- Full clinical study reports
- Efficacy data compared to current standard treatments
- Safety analysis, including any adverse events
- Overall risk–benefit assessment
Since clinical outcomes drive final approval decisions, Module 5 is often considered the heart of the CTD. If regulators trust the data here, your product has a clear path toward marketing authorisation.
Understanding how these modules work together makes the CTD feel less like a puzzle and more like a structured, predictable playbook. And once you see the logic behind it, working with the CTD becomes a lot easier—and a lot less overwhelming.
How Lifescience Intellipedia Helps You Navigate CTD ?
Most companies don’t struggle because the CTD is impossible. They struggle because the details are relentless, regional rules, shifting formats, cross-module consistency, endless documentation checks. That’s where Lifescience Intellipedia steps in and makes the entire process feel lighter, faster, and far more predictable.
As a regulatory affairs consulting partner, we help businesses move through CTD preparation and submission without the usual chaos. Our team brings deep expertise across global markets, so your dossiers are built not just to pass—but to stand strong under scrutiny.
Here’s how we make the difference:
- End-to-end CTD support: From planning and content creation to final QC and submission.
- Region-specific expertise: Smooth handling of Module 1 requirements across the US, EU, Japan, and emerging markets.
- Technical precision: Complete support regarding quality, documentation support both clinical and non-clinical, so that each of your module is perfectly aligned.
- Regulatory intelligence: With our other pharmaceutical market intelligence products such as Chemxpert and Clival, our team is up-to-date with the latest guidelines to make your submissions future-proof.
- Efficiency and compliance: Our team of experienced experts ensure faster documentation process, resulting fast approvals and reduced errors.
In a world where even small mistakes can delay approvals by months, having the right regulatory partner isn’t optional—it’s strategic. With Lifescience Intellipedia, you get a clear, reliable path through the CTD landscape so your product reaches the market with confidence and speed.
