Last Updated : August 22, 2019
Details
Project Line:
Reimbursement Review
Project Sub Line:
Pharmaceutical Review Update
Consultations on the Canada's Drug Agency Pharmaceutical Review Programs
1. Extension of the Consultation Feedback Period
At the request of stakeholders, Canada's Drug Agency has extended the deadline for feedback from September 13, 2019, to September 27, 2019, for the following consultations:
- Proposal to Enhance the Transparency of the Canada's Drug Agency Review Reports and Recommendations
- Proposal to Revise Category 1 Requirements for Canada's Drug Agency Single Technology Reviews
- CADTH’s Proposed Reassessment Framework.
Canada's Drug Agency Program Updates
1. Updated Procedure for Implementation Panels
Canada's Drug Agency has revised its procedures for implementation panels to allow representatives from l‘Institut national d'excellence en santé et services sociaux (INESSS) and/or INESSS’s expert review committee members to attend the implementation panel meetings.
2. Canada's Drug Agency and Canadian Blood Services Pilot Process
Canada's Drug Agency and Canadian Blood Services will be announcing a new pilot process for the review of selected plasma-related drugs in the near future. The pilot process will build upon the strengths of both agencies to provide stakeholders with an objective, transparent, evidence-informed review process for plasma-related products.
3. Updated and Aligned Terminology
Canada's Drug Agency has updated the language in its procedures to align key terminology in our drug review processes. The term “sponsor” will now replace “applicant” and “submitter” in the Common Drug Review and pan-Canadian Oncology Drug Review procedures, respectively.
4. Updated Procedure and Submission Guidelines for the Canada's Drug Agency Common Drug Review
The Procedure and Submission Guidelines for the Canada's Drug Agency Common Drug Review has been updated with the following revisions:
- revised terminology with “sponsor” replacing “applicant”
- updated procedure for implementation panels
- clarified pharmacoeconomic requirements.
Sponsors who have questions about specific requirements may contact Canada's Drug Agency for guidance on submission preparation by emailing requests@cda-amc.ca.
Last Updated : August 22, 2019