Health Canada: Validation Rules for Regulatory Transactions in eCTD and Non-eCTD Formats

Health Canada has released detailed guidances addressing the validation rules for regulatory transactions submitted in two formats: "Validation rules for regulatory transactions in electronic Common Technical Document (eCTD) format" and "Validation rules for regulatory transactions in non-eCTD format". These documents serve as essential frameworks for ensuring consistency, accuracy, and compliance in regulatory submissions for drugs and health products.

Guidance: Validation rules for regulatory transactions in electronic Common Technical Document (eCTD) format

Overview

The electronic Common Technical Document (eCTD) is an internationally recognized standard for submitting regulatory information electronically. Health Canada has mandated specific validation rules to ensure that all eCTD submissions comply with technical and regulatory requirements, facilitating seamless review processes.

Key Validation Rules

1. Submission Structure and Format:

   • Submissions must follow the ICH eCTD specifications, including Module 1 for Canada-specific requirements.

   • Proper folder structures and filenames are critical to avoid validation errors.

2. Technical Validations:

   • All submissions undergo automated validation using Health Canada’s validation tool.

   • Common technical issues include missing or improperly named files, incorrect XML backbones, and invalid hyperlinks.

3. Regulatory Compliance:

   • Applications must meet specific requirements for content and metadata, such as sequence number, application type, and dossier lifecycle attributes.

4. Error Classification:

   • Errors are categorized into critical, major, and minor, with critical errors requiring immediate rectification before submission acceptance.

   • Examples of critical errors include:

     • Incorrectly implemented file formats.

     • Missing application form or sequence metadata.

Version of the eCTD validation rules: 5.3

Effective date: May 31, 2025

For detailed guidance, refer to Health Canada’s validation rules for eCTD format.

Guidance: Validation Rules for Regulatory Transactions in Non-eCTD Format

Overview

The non-eCTD electronic-only format is an alternative for sponsors who are not yet transitioning to eCTD. This format also follows strict validation rules, ensuring clarity and accuracy in submissions.

Key Validation Rules

1. Submission Format:

   • Submissions should be structured using common electronic formats (e.g., PDF files).

   • Proper naming conventions and organization of folders are mandatory.

2. File and Metadata Validation:

   • Each file must be appropriately named and placed in its designated folder.

   • Metadata such as dossier ID, product name, and transaction type must match the application’s accompanying forms.

3. Error Classification:

   • Errors in the non-eCTD format are also classified as critical, major, or minor.

   • Critical errors include:

     • Missing mandatory documents like cover letters.

     • Corrupt or inaccessible files.

4. Data Integrity:

   • Sponsors must ensure that electronic documents are virus-free and secure.

   • Hyperlinks within documents should be functional and directed to the correct sections.

Version of the non-eCTD validation rules: 5.3

Effective date: May 31, 2025

For complete details, refer to Health Canada’s validation rules for non-eCTD format.

Advantages of Non-eCTD Format:

• Ease of Use: Ideal for sponsors without access to eCTD systems.

• Flexibility: Allows submission of simpler applications while adhering to regulatory standards.

Comparing eCTD and Non-eCTD Validation

Feature	eCTD Format	Non-eCTD Format
Validation Tool	Automated, using Health Canada’s eCTD validator.	Manual and less automated than eCTD.
Error Handling	Critical, major, and minor classification.	Similar error classifications with a focus on file organization.
Structure	Based on ICH eCTD specifications.	Standardized but simpler folder and file naming.
Global Compatibility	Aligned with international guidelines.	Limited to regional compliance.

Conclusion

Both guidances by Health Canada underscore the importance of meticulous preparation and compliance in regulatory submissions. Whether transitioning to the internationally harmonized eCTD format or continuing with the non-eCTD electronic-only format, sponsors must adhere to validation rules to ensure timely acceptance and review of their applications.

For more details, consult the official Health Canada resources for eCTD format and non-eCTD format.