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Health Canada: Guidance on Validation rules for Regulatory Transactions in the eCTD Format

The eCTD format represents a standardized electronic submission format for regulatory documents, used globally by regulatory agencies to streamline the submission and review process. Health Canada has embraced this format to enhance efficiency and transparency in the regulatory review of drug submissions.

Validation rules act as the gatekeepers, ensuring that submitted electronic documents meet predefined criteria for format, structure, and content. By adhering to these rules, pharmaceutical companies can significantly reduce the likelihood of submission errors and enhance the chances of a successful review process.

This guideline is intended to reduce errors and follow-ups with Sponsors by ensuring Sponsors provide valid electronic transactions to Health Canada. The Sponsors are encouraged to use a commercially available tool to validate their regulatory transactions in eCTD format, before filing them to Health Canada.

Regulatory transactions are validated by Health Canada before they are released to sponsors, and if the validation fails due to one or more errors detected, a .pdf validation report is emailed to sponsors.

The Effective date: is April 1, 2024.

Adhering to validation rules for eCTD submissions to Health Canada is not just a regulatory requirement; it's a strategic investment in the success of drug approvals.

Click this LINK to know more about the eCTD format Validation Rules.

Also click this LINK if you are looking to know more about "Validation Rules for regulatory transactions filed in non-eCTD format"


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