Health Canada Updates DEL Screening Process to Improve Efficiency

by | Nov 6, 2026 | Health Canada Updates, OTC Drugs

Health Canada has published Drug Establishment Licensing (DEL) Bulletin No. 196, officially dated October 15, 2026. This bulletin introduces procedural modifications to how Health Canada screens DEL applications, aiming to minimize red tape and enhance overall processing efficiencies. 

Key Procedural Updates:

The bulletin outlines several critical changes to the submission and screening process for regulated entities:

  • Combined Screening Timelines: Health Canada is streamlining its notification process. For applications involving foreign buildings that utilize full Good Manufacturing Practice (GMP) evidence, including requests for extending a New Evidence Required By (NERBY) date, applicants will now receive a single, combined screening completion notice within 95 days. This consolidates the previously separate DEL screening completion notice and the GMP screening acceptance notice, and Health Canada will no longer issue a standalone DEL screening completion notice at the 65-day mark.
  • Modified Milestone Targets: For applications assigned to Stream 3 (foreign building applications requiring full GMP evidence review), Health Canada will now issue either a GMP compliance notification or a GMP compliance notification of a NERBY extension grant within 170 days, adjusting the previous target of 140 days.
  • GMP Evidence Submission Methods: While Health Canada continues to recommend that importers submit GMP evidence concurrently with their DEL application, they are introducing greater flexibility. GMP evidence can now be submitted directly from the foreign building or by a third party acting on its behalf.
  • LiquidFiles Implementation: To facilitate the secure transfer of large data packages, the bulletin introduces the use of LiquidFiles for submitting GMP evidence. For files exceeding 1 GB, applicants must submit them in batches using this system. 

While these changes alter submission mechanisms and specific milestone notifications, Health Canada has explicitly stated that the overall DEL application service standards established in guidance document GUI-0127 remain unchanged.

Companies importing or manufacturing within Canada should review these updated timelines and coordinate with their foreign sites and third-party auditors to ensure GMP evidence submissions align with the new LiquidFiles procedures and combined screening targets.

Our team is here to assist you with DEL applications, reach out today.