NHP Management of Applications Policy (MAP) Released Today

Posted Date: 17-December-2025

Explanatory Notes for Drug Establishments on the Preparation of a Site Master File (GUI-0005)

The Wave 1 updates to the MAP, developed in collaboration between your PCMA committee and Health Canada, have been published today.

The new document, effective today may be found here.

The goal of the consultation was to create efficiencies and eliminate outdated information.  This wave focused efforts on practical updates – simplifying processes, reducing stakeholder burden, and ensuring the document reflects how applications are managed today.

As part of our advocacy efforts, we requested that Health Canada reinstate the Product Licensing Guidance Document and remove all product licensing content from the MAP. While Health Canada decided not to implement this in wave 1, they indicated they would consider redefining the MAP’s purpose in wave 2 and clearly distinguish between product licensing activities and application management activities at that time.

Stay tuned for engagement on wave 2 which is expected shortly and will focus on:

  • additional process improvements;
  • outstanding feedback from industry associations, particularly around reducing applicant burden; and,
  • potential policy changes.