- 2019 CDEC Meeting Schedule Released
- A new schedule format includes submission deadlines and guidance on when manufacturers can expect embargoed and final recommendations.
- Updated Advance Notification Form (effective immediately)
- New form includes an acknowledgement that information provided in the form may be shared with federal, provincial and territorial governments, their agencies and departments and the pan-Canadian Pharmaceutical Alliance.
- Patient groups who provide input to be identified in product’s Key Milestone table online
- Applies to CDR submissions and resubmissions received on or after July 2, 2018.
- CDR-participating drug plans may attend pre-submission meetings (effective immediately)
- Updated CDR Submission Guidelines & Procedures documents to be published June 2018
A preview of key changes include:
- Category 1 Requirements:
- Cover letter requirements to be reduced
- New consolidated template for letters
- No longer required: Literature Search Strategy, CONSORT Diagrams and Health Canada reviewers report
- Category 2 Requirements:
- No longer required: Certified Product Information Document (CIPD)
- Filing date will be ≤ 20 business days from the date accepted for review (instead of ≤ 20 business days prior to target CDEC meeting)
- Cover Letter is no longer required
- Therapeutic review process revisions:
- to include reassessment of existing CDEC recommendations
- Category 1 Requirements:
For more information, please consult the CDR Update 136 Newsletter.