Draft Guidance: Accelerated Review of Human Drug Submissions
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Health Canada is working to improve access to drugs for serious, life-threatening, or severely debilitating diseases or conditions. Their Regulatory Review of Drugs and Devices is a comprehensive plan to modernize many parts of the system.
This consultation is the result of proposed changes to the Priority Review of Drug Submissions policy and the Notice of Compliance with Conditions policy. CSHP members are invited to review Draft Guidance: Accelerated Review of Human Drug Submissions and provide their comments to CSHP. (You’ll need to log in to CSHP’s website to obtain a copy of the draft guidance.)
While recognizing that the guidance document is written for drug sponsors from the pharmaceutical industry, CSHP would like to hear from you, in regards to these 3 areas:
- Single pathway for accelerated review status
The guidance document proposes one pathway, eliminating the need for the 2 pathways currently defined under policy (named above).
- Criteria for submissions seeking accelerated review status
There are 4 criteria for product eligibility for accelerated review introduced in the draft guidance.
- Options for screening submissions
Two options are given regarding the timing of when the submission screening and eligibility for accelerated review occurs.
CSHP members who would like to share their comments with Health Canada are asked to write to firstname.lastname@example.org by July 17, 2019. When providing your comment, please indicate the relevant section of the guidance, along with a proposed revision (as relevant).