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Health Canada Moves to Regulatory E-Submissions System

By Dan Stanton , 21-Mar-2013

Health Canada says moving to an electronic filing system for regulatory submissions will reduce costs but warned drugmakers not to include their credit card details.

The regulatory body announced that as of June 1 this year it will only accept administrative regulatory submissions in either an electronic common technical document (eCTD) format or as a Portable Document Format (PDF) file.

William Wells, a spokesman for Health Canada, told in-Pharmatechnologist.com the move to the new system “will reduce costs of handling, storage and transportation of paper documents.”

“Stakeholders are already filing the majority of their drug submissions electronically,” he continued to add. “This notice is simply to add administrative submissions to the list of drug submissions that can now be accepted in electronic format.”

Uploaded electronic documents will be immediately accessible to Health Canada staff involved in the regulatory process and will fall under good record management protocol to ensure: authenticity, integrity, availability, traceability, and non-repudiation of the data.

According to Wells “Health Canada already has a secure electronic viewing and storage tool for drug submissions which has been successfully used for over 5 years” and thus the body envisions that security issues will not pose a problem for automated administrative submissions. Health Canada does, however, advise sponsors against including credit card or payment information within their submissions.

The electronic submissions to Health Canada - which include cross licensing agreements, product name changes or company name changes – must include a cover letter explaining the nature of the proposal in both paper and electronic form

Furthermore, in order to submit data, Health Canada will only support recordable CDs and DVDs which it requires to be labeled with sponsor and brand name, eCTD identifier and sequence number (where applicable), date of filing and verification of virus-free status.

Wells said Health Canada has provided a number of guidance documents available for its sponsors regarding the new submission protocol and regular updates on electronic activities can be found on the regulatory board’s website.

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