Consultation on Draft Guidance: Accelerated Review of Human Drug Submissions

Current status: Closed

The consultation ran from May 7, 2019 to July 21, 2019.

Health Canada is announcing a 75 day consultation on the draft Guidance: Accelerated Review of Human Drug Submissions. The consultation will be open for comment beginning May 7, 2019 and will close July 21, 2019.

Health Canada is committed to working with health partners in order to improve access to those drugs that are needed most by Canadians. Under the Regulatory Review of Drugs and Devices initiative, Health Canada has consulted on priority review pathways and health care system needs in order to make determinations about which products could be reviewed under shortened timelines. Feedback from these consultations has resulted in proposed modifications to both the Priority Review of Drug Submissions policy and the Notice of Compliance with Conditions policy and these are reflected under a new title: Draft Guidance: Accelerated Review of Human Drug Submissions.

The draft guidance applies to New Drug Submissions (NDS) or Supplement to New Drug Submissions (SNDS) in support of a prescription pharmaceutical, biologic or radiopharmaceutical drug product for human use for serious, life-threatening or severely debilitating diseases or conditions. Certain elements of the guidance are also applicable to generic pharmaceuticals where the innovator product has a conditional authorization.

Health Canada is seeking your feedback on the overall clarity and content of the draft guidance. In addition, it is important we hear your views on the following proposed elements which are outlined in detail in the draft guidance:

  • the single pathway for accelerated review
  • two different options for screening processes  
  • the eligibility criteria for drug product submissions seeking an accelerated review status

How to participate

To request the guidance document please email hc.regulatory_review-examen_reglementaire.sc@canada.ca

You will receive:

  • The draft guidance document, and
  • The form for your comments, by section number and line number.

Please email your comments to hc.regulatory_review-examen_reglementaire.sc@canada.ca using the form provided. All comments will be considered in the finalization of the guidance. The 75 day consultation period is from May 7, 2019 to July 21, 2019, inclusive.

Comments can also be mailed to:

Regulatory Review of Drugs and Devices
Health Products and Food Branch
Health Canada
100 Eglantine Driveway, Room 3303
AL 0603B
Ottawa, ON
K1A 0K9

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