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CDR Update — Issue 135

Last Updated: March 28, 2018
Result type: Reports
Product Line: CDR Update Newsletter

Application Fees for CADTH Pharmaceutical Reviews — Adjustment In February 2018, CADTH announced that beginning in April 2018 application fees for CADTH Pharmaceutical Reviews will be adjusted annually based on fluctuations in the Consumer Price Index. Today we have updated our Guidelines for Manufacturers on Application Fees for CADTH Pharmaceu...

CDR Update — Issue 134

Last Updated: March 8, 2018
Result type: Reports
Product Line: CDR Update Newsletter

CADTH Common Drug Review Submissions May Be Filed up to 180 Days before Market Authorization As part of Health Canada’s Regulatory Review of Drugs and Devices (R2D2) initiative, CADTH is committed to reducing the interval between Health Canada’s approval of a drug for marketing in Canada and CADTH’s issuance of reimbursement recommendations. In ...

CDR Update — Issue 133

Last Updated: February 13, 2018
Result type: Reports
Product Line: CDR Update Newsletter

1. Revisions to CADTH’s Biosimilar Review Process In August 2017, CADTH issued a consultation to seek input on how biosimilar reviews could be enhanced in Canada. CADTH would like to thank all stakeholders who responded to the consultation on the proposed changes to the biosimilars process for the CADTH Common Drug Review (CDR) and the CADTH pan...

CDR Update — Issue 132

Last Updated: December 12, 2017
Result type: Reports
Product Line: CDR Update Newsletter

1. Update on Revised Process for Biosimilars In August 2017, CADTH invited stakeholder comments and feedback on a proposal to revise the submission and review process for biosimilars through CADTH’s Common Drug Review (CDR) and pan-Canadian Oncology Drug Review (pCODR) programs. Based on feedback from stakeholders, CADTH will be implementing a r...

CDR Update — Issue 131

Last Updated: November 27, 2017
Result type: Reports
Product Line: CDR Update Newsletter

Collaborative Workspaces: Revised Process for Filing CDR Submissions and Resubmissions The CADTH Common Drug Review (CDR) is aligning the process for secure file sharing with the pan-Canadian Oncology Drug Review (pCODR) by implementing Collaborative Workspaces, a secure portal to receive and exchange documents with CDR applicants. The Collabora...

CDR Update — Issue 130

Last Updated: November 13, 2017
Result type: Reports
Product Line: CDR Update Newsletter

1. Revised Procedure for the CADTH Common Drug Review Resubmissions In August 2017, CADTH invited stakeholder comments and feedback on a proposal to revise the resubmission requirements for its Common Drug Review (CDR) and pan-Canadian Oncology Drug Review (pCODR) programs. Based on feedback from stakeholders, CADTH has implemented the proposed ...

CDR Update — Issue 129

Last Updated: October 11, 2017
Result type: Reports
Product Line: CDR Update Newsletter

In August 2017, CADTH invited stakeholder comments and feedback on a proposal to revise the resubmission requirements for its Common Drug Review (CDR) and pan-Canadian Oncology Drug Review (pCODR) programs. Based on feedback from stakeholders, CADTH will be implementing the proposed revision to the resubmission eligibility criteria and a new ran...

CDR Update — Issue 128

Last Updated: September 28, 2017
Result type: Reports
Product Line: CDR Update Newsletter

1. Revised Procedure for Advance Notification of Pending CDR Submissions and Resubmissions In September 2016, CADTH updated the advance notification procedure for the Common Drug Review (CDR). Since implementation, CADTH has continuously evaluated the effectiveness of the 120-day advance notification procedure and has carefully considered all fe...

CDR Update — Issue 127

Last Updated: September 11, 2017
Result type: Reports
Product Line: CDR Update Newsletter

1. Extended Initiation Range for January 2018 CDEC Meeting CADTH has extended the initiation range for its Common Drug Review (CDR) submissions targeting the January 17, 2018 Canadian Drug Expert Committee (CDEC) meeting. Reviews initiated by September 20, 2017 will target the January 2018 CDEC meeting (revised from September 11, 2017). 2. Pharm...

CDR Update — Issue 126

Last Updated: August 14, 2017
Result type: Reports
Product Line: CDR Update Newsletter

1. Extended Initiation Range for December 2017 CDEC Meeting CADTH has extended the initiation range for Common Drug Review (CDR) submissions targeting the December 13, 2017 Canadian Drug Expert Committee (CDEC) meeting. Reviews initiated by August 23, 2017 will target the December 2017 CDEC meeting (revised from August 14, 2017). This revision h...