Common Technical Document (CTD) is a common standard format for submitting regulatory documents to the respective regulatory authorities for gaining a marketing authorization in the respective country. It describes how one should organize the documents to submit to the regulatory authority for the approval of market of a drug.
Read more about eCTD and its submission process in this article.
What Is eCTD?
Electronic Common Technical Document (eCTD) is the electronic version of CTD. eCTD submission streamlines the process of submission of regulatory documents to the health authorities for the purpose of marketing the drug. It is the standard format for submitting regulatory documents.
eCTD Regulatory Requirements
eCTD provides a harmonized solution to implement the common technical document electronically. eCTD uses an XML backbone that cross-links the required documents and provides with information regarding the submission. The regulatory requirement for submitting eCTD is that it must be submitted in a structured format which is discussed below in detail.
Structure And Components Of eCTD
eCTD is composed of 5 modules. Module 1 is specific to each region. Modules 2, 3, 4, and 5 are considered to be common for all regions. Each module is discussed below.
Module 1: Regional Administrative Information
It must contain region specific administrative information. This is not considered as a part of CTD since this module is specific to each market regulator. Regional guidance will provide specific instructions on how to provide the administrative forms and detailed prescribing information.
Module 2: Summary overview
This module communicates about the summary and overview of quality, safety and efficacy. These three sections are discussed in a detailed manner in the coming modules of eCTD. Module 2 consists of:
2.2 Introduction
2.3 Quality Overall Summary
2.4 Nonclinical Overview
2.5 Clinical Overview
2.6 Nonclinical Written and Tabulated Summaries
2.7 Clinical Summary
Module 3: Quality
Module 3 presents the chemistry, manufacturing and control reports for the products. ICH M4Q guideline provide the complete details on what should be included in this module. The main headings in this module are:
3.2 Body of Data
3.2.S Drug Substance
3.2.S Drug Substance [Drug Substance Name] [Manufacturer]
3.2.P Drug Product (name, dosage Form)
3.2.P Drug Product (name, dosage Form)
3.2.A Appendices
3.2.R Regional Information
3.3 Literature References
Module 4: Non-Clinical Study Reports
This module speaks about pharmacological, pharmacokinetic and toxicological evaluation of the drug substance or product. The detailed structure and content for module 4 is provided in ICH M4S guideline. Main headings coming under this module is as follows:
4.2 Study Reports
4.2.1 Pharmacology
4.2.2 Pharmacokinetics
4.2.3 Toxicology
4.3 Literature References
Module 5: Clinical Study Reports
Module 5 of eCTD is about the clinical study reports. It contains the clinical data of all the clinical studies as a part of evaluation of the drug product. ICH M4E guideline specifies the structure and the components that must be involved in module 5. The main headings included are:
5.2 Tabular Listing of all Clinical Studies
5.3 Clinical Study Reports
5.3.1 Reports of Biopharmaceutic Studies
5.3.2 Reports of Studies Pertinent to Pharmacokinetics using Human Biomaterials
5.3.3 Reports of Human Pharmacokinetic (PK) Studies
5.3.4 Reports of Human Pharmacodynamic (PD) Studies
5.3.5 Reports of Efficacy and Safety Studies
5.3.6 Reports of Post-marketing Experience
5.3.7 Case Report Forms and Individual Patient Listings
5.4 Literature References
Submission Types That Require An eCTD
Submission types requiring an eCTD is as follows:
New Drug Applications (NDA)
Abbreviated New Drug Applications (ANDA)
Investigational New Drug Application (Commercial IND)
Biologics License Application (BLA)
Master files: Drug Master File (DMF) and Biologics Master File (BMF)
Emergency Use Authorization (EUA)
Note: All subsequent submissions to NDA, ANDA, BLA, commercial IND including amendments, supplements and reports.
The Categories for which electronic submissions are optional but are encouraged are the non-commercial IND, submissions for blood and blood components (including source plasma), submissions for type III master files.
eCTD Submission Process
Here are the eCTD submission process for different regulatory authority bodies such as FDA, EMA & TGA.
eCTD For FDA
Step 1: Review the electronic submission resources
Step 2: Request an application number
Step 3: Register for an Electronic Submissions Gateway Account
Step 4: Send a sample submission to FDA
Step 5: Submit via the Electronic Submission Gateway
eCTD For EMA
Step 1: Review the eCTD submission/Nees submissions guidance
Step 2: Submit electronic Application Forms (eAF) and compliant PDFs
Step 3: Request for submission number
Step 4: Register for an eSubmission gateway and eSubmission web client
Step 5: Submit via the eSubmission gateway and eSubmission web client.
eCTD For TGA
Step 1: Check whether the eCTD is an accepted format for submitting.
Step 2: Make sure you have a client ID (Omit this step if you have one)
Step 3: Get an e Identifier (Omit this step if you have one)
Step 4: Compile and publish the sequence
Step 5: Validate the sequence
Step 6: Sending this sequence to the eSubmissions team.
Advantages Of eCTD
CTD used to be submitted in a paper document format which contains several pages which makes it difficult for storing the data. ECTD decreased the need for paper documentation and its storage. Since in eCTD there are hyperlinks and bookmarks provided, navigation process becomes simpler.
The electronic version of CTD allows for simultaneous access. Any future amendments can be cross referred to the information in the previous eCTDs. It promotes standardization and provides the reviewers with a more efficient and effective reviewing process. This implementation serves as a great saving of time and money.
Challenges In eCTD Submissions
Some of the common challenges are as follows:
Data privacy and security
Granularity
Lack of experience
Lack of compliance with the regulatory format.
The stringent eCTD format does not provide much leverage in the product lifecycle and metadata.
Error in hyperlinking and bookmarks.
Regional variations in hyperlinking, bookmarks and pdf versions.
How To Effectively Manage eCTD Challenges?
Incorporate interdisciplinary expertise from fields such as technology, law, ethics, and cyber security to ensure comprehensive oversight and governance.
Knowledgeable employees.
Staying up to date with technology.
Understanding the documents or pdfs needed depending on the product and the region.
Always check for the latest guidance updates on eCTD submissions.
Use of regulatory publishing automation tool.
Facing these challenges and staying up to date with the eCTD submission changes can be exhausting. We provide comprehensive, end to end electronic submission services to assist youin navigating smoothly through eCTD submission processes. Reach out to Artixio Consulting for regulatory support at info@artixio.com
FAQs About eCTD Submissions
What is the full form of eCTD?
The full form of eCTD is Electronic Common Technical Document. It is the electronic version of CTD.
Why is eCTD important for regulatory submissions?
Each company tends to submit the regulatory information in their own ways which leads to an unstandardized format of submission. Implementing eCTD ensures that all the companies are required to submit the regulatory information in a standardized format which allows for easier reviewing process.
What is the need for validation in eCTD submissions?
Validation is done so as to make sure that the submissions made are free form error and is also in compliance with the regulatory requirements. It also decreases the chance of eCTD rejection.
Can small companies manage eCTD submissions in-house?
Yes, but it is challenging as it requires investment in training, expertise, software etc... Outsourcing is a considerable option as it provides access to regulatory expertise without the need for complexing their process further by managing specialized software by themselves. Artixio Consulting can help provide you with guidance.
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