Electronic common technical documents (eCTD) has become 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 State Food and Drug Administration (USFDA). Staying update with current requirements and criteria, makes the regulatory submission process easy and minimizing 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 makes 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 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 incorrected metadata.
- Low Level Errors: These includes mirror 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 update the validation criteria for eCTD, ensuring its compliance with regulatory standards, some of the recent validation criteria includes:
- Module 1 Validation: To enhance metadata checks, specific validation checks with respect to regulatory submission (example, Form 364h compliance), and improved checks for regional documents to maintain accuracy.
- Sequence Number Validation: Each documents must be in sequence, inconsistency in number sequence may lead to rejections.
- Checksum Validation: Mismatched or missing checksum may be considered as significant error. System check for maintaining integrity of documents is done through checksum validation.
- PDF Specifications: Documents in PDF form is the major requirement for effective regulatory submission, hyperlink of PDF allows high functionality and efficiency.
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
What Are the Components of eCTD Dossier?
The eCTD dossier is divided into five modules:
Module 1 demonstrate the administrative information along with region specific.
Module 2 includes summary of module 3,4 and 5.
Module 3 consist of quality details of drug having both drug substance and drug product part.
Module 4 have non clinical information, which is considered non applicable for generic drugs.
Module 5 consist of clinical information about drug.
What Software’s Are Used For eCTD Submission ?
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.
Which Regulatory Authorities Requires eCTD Dossier Submissions?
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.