Dossier and Common Technical Document (CTD)

DOSSIER
PREPARATION AND
SUBMISSION
Presented By : Nidhi Tanwar
M. Pharm
Pharmaceutical Regulatory Affairs
SGT College of Pharmacy
SGT University
Gurugram
Guided By : Dr Bindiya Chauhan


A dossier refers to a comprehensive collection of documents submitted to a regulatory
authority to demonstrate that a product, such as a pharmaceutical drug, medical device, or
cosmetic, meets the necessary requirements for approval. This may include data on safety,
efficacy, quality, manufacturing processes, labeling, and compliance with applicable
regulations.

The dossier serves as the basis for the regulatory review process, helping authorities
evaluate whether to grant marketing authorization or other approvals.

The most common format for a dossier is the electronic common technical document
(eCTD), which is a digital format.

In the U.S., an eCTD dossier is called a New Drug Application (NDA), and in the European
Union and other countries, it's called a marketing authorization application (MAA).
INTRODUCTION 1

Paper Submissions 2
A dossier paper submission is the process of compiling and submitting a collection of data and
records to regulatory authorities to get approval for the distribution and commercialization of a
product.
Here are some things to consider when preparing a dossier paper submission:
1. Format - some countries require a specific format or layout for the dossier, such as CTD or
ASEAN dossier. Other countries may only require a list of documents without any presentation
specifications.
2. Electronic submission - some countries prefer or require electronic submission.
3. Document organization - applicants can organize documents in folders that correspond to
the CTD modules relevant to the application.

3
4. Document size - documents included in an OTC dossier should generally be
no larger than 100 megabytes (MB).
5. Hard copy - if the content exceeds 20 sheets of paper, the information should be presented
in binders with durable covers. The external dimensions of the binders should not exceed 270
mm in width, 320 mm in height, and 80 mm in thickness.
6. Access management - the dashboard owner can add team members to any of their
dossiers. New users must be added with the same email address as their EU login.

4
Dossier paper submissions in regulatory affairs typically includes:
Product Information: Detailed descriptions of the product, including formulation and
specifications.
Preclinical Data: Results from laboratory and animal studies that assess safety and efficacy.
Clinical Data: Data from human clinical trials, including study protocols, results, and analysis.
Manufacturing Information: Details on the manufacturing process, quality control measures,
and facility information.
Labeling: Proposed labels, inserts, and packaging materials, including claims and usage
instructions.
Regulatory Compliance: Documentation demonstrating adherence to applicable regulations
and standards.

Common Technical
Document(CTD)
The Common Technical Document
(CTD) is a standardized format for
submitting applications to register
medicines with regulatory
authorities.
Overview

It is organized into five modules:

Module 1

Module 2

Module 3

Module 4

Module 5
Structure
5

6
Overview
The CTD was developed by the International Council for Harmonisation (ICH) to streamline the
process of registering new medicines across different countries.
Purpose
The CTD's primary purpose is to simplify the process of preparing and evaluating dossiers for
registering medicines.
Enhance the consistency and efficiency of regulatory reviews.
Facilitate better communication between regulatory authorities and applicants.
Serve as an essential tool for both external agency reviewers and internal pharmaceutical
reviewers.
The CTD is a vital tool for regulatory submissions, by adhering to the CTD guidelines and
understanding the specific requirements of the relevant regulatory authorities, pharmaceutical
companies can significantly improve their chances of successful product registration.

8
The CTD is organized into five distinct modules, with Module 1 containing region-specific
administrative information and the remaining modules being common across all regions:

Module 1: Regional Administrative Information
Includes application forms, proposed labels, and other regional-specific documents.

Module 2: Summaries and Overviews
Provides a comprehensive summary of the detailed reports in later modules, including:

Quality Overall Summary

Nonclinical Overview

Clinical Overview
CTD Structure and
Format

9
Module 3: Quality
Details the pharmaceutical properties and manufacturing information, including:

Drug substance and product specifications

Manufacturing process controls

Stability data

Module 4: Nonclinical Study Reports
Contains data on preclinical studies, covering:

Pharmacology

Pharmacokinetics

Toxicology

Module 5: Clinical Study Reports
Presents data from clinical trials on the safety and efficacy of the pharmaceutical product,
including:

Study protocols and methodologies

Results and interpretations

10
Electronic Common Technical Document (eCTD) submissions represent the digital version of
the CTD format, facilitating the submission process for regulatory approvals of pharmaceuticals
and biologics. The concept of the eCTD was developed in the late 1990s as part of an effort to
harmonize the regulatory submission process across different regions, including the United
States, Europe, and Japan.
Key Features of eCTD Submissions
1. Structured Format

Maintains the same five-module structure as the traditional CTD but is formatted for electronic
submission.

Allows for easy navigation through hyperlinks and bookmarks.
2. Interactivity
Includes features such as hyperlinks to documents and sections, making it easier for reviewers
to access relevant information quickly.
Electronic CTD Submissions

11
3. Life Cycle Management
Supports updates and amendments to submissions, allowing sponsors to submit new
information or corrections while maintaining a clear history of changes.
4. Compliance with Regulatory Standards
Designed to meet the specifications set by regulatory authorities like the FDA, EMA, and others,
ensuring compatibility with their submission systems.
5. Data Integrity and Security
Ensures the integrity and security of submitted data through secure file formats and electronic
signatures, complying with regulatory requirements for data protection.
Benefits of eCTD Submissions

Efficiency: reduces the time and costs associated with preparing and submitting applications.

Reduced Paper Use: minimizes the reliance on paper documents.

Faster Review Processes: streamlined submissions can lead to quicker review times.

Global Standardization: Facilitates international submissions

12
The eCTD is required for certain types of submissions to the FDA, including:

> NDAs - New Drug Applications > ANDAs - Abbreviated New Drug Applications

> BLAs - Biologics License Applications > Commercial IND applications

> Master files, such as DMFs
Steps for Planning an eCTD Submission
1. Understand Regulatory Requirements.
2. Establish a Submission Timeline.
3. Develop a Submission Strategy

Determine the scope of the submission (e.g., new drug application, biologics license application).

Identify key stakeholders (e.g., regulatory affairs, clinical, quality, and IT teams) and define their
roles in the process.
Planning Electronic CTD
Submissions

13
4. Organize Documentation: gather all necessary documents for each module
(Quality, Nonclinical, Clinical, etc.).
5. Prepare Module 1 (Regional Requirements)
6. Compile Common Technical Document Summaries (Module 2)
7. Create the Quality Module (Module 3)
8. Gather Nonclinical and Clinical Study Reports (Modules 4 and 5)
9. Review and Quality Assurance: conduct thorough internal reviews of all documents to
ensure accuracy, consistency, and compliance.
10. Electronic Submission Preparation:

Use eCTD publishing software to compile the documents into the eCTD format.

Validate the eCTD package to check for errors and ensure adherence to specifications.
11. Submission and Tracking

Challenges in eCTD
Submission
Inconsistent Document Formatting
Navigation Errors in Hyperlinking and
Bookmarking
Technical Validation Errors
Common Challenges
Regular Updates: stay updated
with the latest regulatory guidelines.
Quality Checks: implement
multiple rounds of quality checks.
Expert Review: consider engaging
with regulatory experts.
Tips for Ensuring Compliance
14

15
To submit an Electronic Common Technical Document (eCTD) to the FDA, we must meet the
following requirements:
Application number: request an application number from the FDA.
Gateway account: register for an Electronic Submissions Gateway (ESG) account.
Submission size: if the submission is 10 gigabytes or less, we must use the FDA ESG.
Document formatting: ensure all documents are in PDF format and follow the ICH
guidelines(M8 Electronic Common Technical Document).
Document validation: use eCTD validation software to check for technical errors.
Document content: include the following five modules in the submission:

Region-specific information

Summary documents

Quality-related information

Nonclinical study reports

Clinical study reports
Requirements for Submissions

16
Difference between CTD and
eCTD
The Common Technical Document (CTD),
provides a standardized format for
submitting documentation to regulatory
authorities.
Manual document navigation by TOCs,
page numbers and caption cross
references.
Submitted in binders in boxes.
Guidelines given under ICH
Multidisciplinary Guidelines(M4).
CTD- Common Technical Document eCTD- Electronic Common Technical
Document
It is the electronic version of the CTD that
allows applicants to submit regulatory
information electronically to health
authorities.
Electronic document navigation by TOCs,
bookmarks and hyperlinks.
Submitted on CD or DVD or by email or
portal.
Guidelines given under ICH
Multidisciplinary Guidelines(M8).

16
1. https://en.wikipedia.org/wiki/Dossier
2. https://www.ddregpharma.com/what-is-a-dossier-submission
3. https://extranet.who.int/prequal/vector-control-products/dossier-preparation
4. https://www.kolabtree.com/blog/what-is-regulatory-dossier-and-what-does-it-contain/
5. https://en.wikipedia.org/wiki/Common_Technical_Document
6. https://www.ich.org/page/ctd
7.https://www.researchgate.net/publication/333971164_Regulatory_requirements_for_preparation_of_Dossier_for_regi
stration_of_Pharmaceutical_products_in_ACTD_CTD_format
8.https://www.celegence.com/expert-tips-strategies-ectd-submissions
9.https://www.fda.gov/files/drugs/published/eCTD-Submission-Requirements--What-You-Need-to-Know.PDF
Reference

Dossier and Common Technical Document (CTD)

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