This year, Health Canada has issued a number of guidance documents (both draft and final) of interest to Reg Affairs and Reg Ops. In this blog post, we’ll summarize some of the more interesting news.

Revision to the Guidance Document Management of Drug Submissions and Applications

The guidance is being updated to reflect the following:

• Defining the duration of a response to clarification request.
• Removing the Submission Certification requirement for Responses to Submission Deficiency Notice (SDN), Notice of Deficiency (NOD) and Notice of Non-Compliance (NON).
• Reflecting the updates made to the performance standards for Post-authorization Division 1 Changes (PDCs) for prescription pharmaceutical drugs and those administered or obtained through a health professional in the Guidance Document: Post-Drug Identification Number (DIN) Changes. [also see more on this below]

Update to eCTD Validation Rules

Health Canada has updated their eCTD validation rules, effective August 22 2022.
Changes include:

• F14 – Revised to exclude image files in Module 1 from this check, which is that when replacing content, the new content should be different from the previous content.
• F15 – Added new valid file extensions to the list of acceptable formats in the CA regional section.  Acceptable formats now include:
  • Documents: .pdf,.doc,.docx,.xls,.xlsx,.wpd,.ppt,.pptx
  • Images:.png,.gif,.svg,.jpg,.jpeg,.tif,.tiff,.bmp
  • Audio/Video:.wav,.mp3,.mp4,.wmv,.mov,.mpg,.mpeg
  • Coding Language:.xml
  • Data:.dat,.inf,.txt.
• G22 – Added new valid file extensions to the list of acceptable formats in the ICH section.  Acceptable formats now include:
  • Documents:.pdf,.doc,.docx,.xls,.xlsx,.wpd,.ppt,.pptx
  • Images:.png,.gif,.svg,.jpg,.jpeg,.tif,.tiff,.bmp
  • Audio/Video:.wav,.mp3,.mp4,.wmv,.mov,.mpg,.mpeg
  • Coding Language:.xml,.xsl,.xsd,.dtd
  • Data, Modeling and Simulation:.dat,.inf,.txt,.sas,.xpt .wksz,.wksx,.wks (SimCyp workspace files, Pharmaceutical Drugs only) .sdax,.edpdp,.wsp,.epr,.pnf,.psf (Consistency Lot Release Testing Activities, Biologic Drugs only)
• G34 – Added new node extension
• R8 Product Lifecycle Management Information

Draft Guidance (Update) – Switching a medicinal ingredient from prescription to non-prescription status

On April 21, 2022, Health Canada published its revised draft guidance on switching a medicinal ingredient from prescription to a non-prescription status.  Updates include:

• changes to the process for switches from prescription drug to natural health product that will ensure regulatory support;
• clarification of  evidence requirements relative to the Prescription Drug List principles and factors; and
• guidance to industry on completing a new template that is being requested as part of submissions for switches.

This document was for comment purposes only, and the comment period is now closed.  The Torys website has a nice analysis of the changes.

Revised Performance Standards – Revising the Performance Standards for Post-authorization Division 1 Changes

As of August 2, 2022, Health Canada is revising the performance standards for Post-authorization Division 1 Changes (PDCs) for prescription pharmaceutical drugs and those administered or obtained through a health professional. The performance standards for non-prescription pharmaceuticals PDCs and disinfectant PDCs will remain unchanged.

The performance standard for PDCs-prescription drugs that require an assessment by the Pharmaceutical Drugs Directorate (PDD) will change from a 30-day screening (which includes review) to:

• twenty five day screening and a 120 day review for Safety PDCs, and
• twenty five day screening and a 90 day review for Quality PDCs.

Updated Guidance: Preparation of Regulatory Activities in non-eCTD Format. Effective date: 2022/02/28 Guidance on the structure, content and transmission of regulatory transactions filed in the non-eCTD format.  It pertains to:

• Regulatory activities for Human drugs and disinfectants pursuant to Part C – Division 1 and Division 5 of the Food and Drug Regulations
• Regulatory activities for Veterinary drugs pursuant to Part C – Division 1 and Division 8 of the Food and Drug Regulations
• Human and Veterinary Master Files (MFs)