eCTD Submission Latest Validation Criteria
Electronic Common Technical Documents (eCTD) has become the global standard for regulatory submissions. eCTD submission has revolutionized the process of drug approval and registration. This standardized format of eCTD has simplified the communication between pharmaceutical companies and regulatory bodies like United States Food and Drug Administration (USFDA). Staying updated with current requirements and criteria makes the regulatory submission process easy and minimizes the chances of rejections. However, eCTD compliance as per FDA latest validation criteria is difficult for many organisations to achieve. At Medwisdom Lifesciences, our experts in eCTD compliance coupled with regulatory practice make the process of regulatory submission simple for our clients.
What Is The Importance of eCTD Submission?
eCTD plays an important role in simplifying regulatory submission globally especially in US and European markets. It provides a standard format of documents, making it easier for regulatory authorities to review and approve marketing authorization application for drug product. Some of the most important aspects are discussed below:
- Global Standard Format: eCTD format is acceptable and made compulsory by regulatory bodies of specific countries such as United States of America (FDA), Europe (EMA), Canada (CA), GCC, Australia, and Japan (PMDA).
- Data Organization: eCTD makes data well organised and accessible with different modules, helping in easy reviewing.
- Regulatory Compliance: Helps in ensuring regulatory compliance resulting in less rejection by regulatory authorities by fixing errors through validation tools prior to final submission.
- Improve Communication and Collaboration: eCTD helps to simplify the process, making the interaction between pharmaceutical companies and regulatory authorities easier and more collaborative.
- Transparency: Regulatory bodies can locate the required information quickly with ease.
How Is eCTD Validated?
Validation process of eCTD involves the confirmation of quality and regulatory compliance as per the technical specifications and documents. Regulatory authority uses a validation tool for checking the quality of dossier, errors, and compliance, ensuring regulatory submission meets the validation criteria. The validations are categorized into following types:
- High Level Errors: These are the major errors that leads to rejection of application. These includes data such as missing documents or files or corrupted files.
- Intermediate Level Errors: Errors that might results in delays but not cause submission rejections. This may include incorrect metadata.
- Low Level Errors: These includes minor errors that do not affect delays or submission, but should still be addressed. These may include formatting and inconsistency of words.
USFDA Validation Criteria For eCTD Submission
USFDA periodically updates the validation criteria for eCTD, ensuring its compliance with regulatory standards. As of February 2026, submissions use eCTD v3.2.2 (primary) or v4.0 (voluntary for new applications since September 2024; projected mandatory ~2029). Key recent criteria include:
- Module 1 Validation: Enhanced metadata checks, specific validation for regulatory submissions (e.g., Form FDA 356h compliance), and improved checks for regional documents to maintain accuracy.
- Sequence Number Validation: Each document must be in sequence; inconsistency in number sequence may lead to rejections.
- Checksum Validation: Mismatched or missing checksum may be considered a significant error. System checks for maintaining integrity of documents through checksum validation.
- PDF Specifications: Documents in PDF form are a major requirement for effective regulatory submission; hyperlinks in PDF allow high functionality and efficiency. Follow FDA PDF specs (e.g., no unsupported fonts, valid hyperlinks).
- v4.0 Specifics (where applicable): New rules on XML well-formedness, schema validity, US Regional IG OID in message header, character limits for descriptions (e.g., 512 chars for document titles), and unique identifiers/context of use.
High-severity errors (e.g., invalid XML, missing required elements) result in the submission not being received (rejection). Use tools like Lorenz eValidator (current version supporting latest specs) for pre-validation.
How To Submit eCTD As Per Validation Criteria?
For submission of eCTD dossier, following are some latest validation criteria for maintaining compliance:
- Regulatory Updated Tools: Use updated validation software aligned with recent validation criteria for publication eCTD dossier with compliance.
- Conduct Pre-Validation: Perform validation before initial submission to regulatory authority (USFDA) to avoid non-compliance.
- Maintain Documents Quality: Ensure proper number sequences of documents and pdf format for fulfilling requirements and to maintain integrity of dossier.
- Stay Updated: Review the latest updates and visit USFDA website regularly for latest news and updates on validation criteria.
Read Also: Complete Guide To CTD Dossier
How Medwisdom Lifescience Can Assist You With eCTD Dossier Preparation?
At Medwisdom Lifescience, we are specialized in preparing and submitting eCTD dossier, ensuring complete compliance with global regulatory standards, our services includes:
- Electronic Compilation of Module 1 to 5
- Regulatory Documentation
- Error Free Submission
- Cost Effective
- Specific Regulatory Compliance
FAQs
The eCTD dossier is divided into five modules:
Module 1: Administrative information along with region specific.
Module 2: Summary of module 3,4 and 5.
Module 3: Quality details of drug having both drug substance and drug product part.
Module 4: Non-clinical information, which is considered non applicable for generic drugs.
Module 5: Clinical information about drug.
Specialized oriented software’s are required for compilation, validation, and submission of eCTD dossier, some of the most common used software includes Lorenz docuBridge, eCTD office, and Extedo eCTDmanager.
Some of the major regulatory authorities which requires eCTD submission includes USA (FDA), Europe (EMA) and Japan (PMDA). Each regulatory authority have specific regulatory requirements.
