Last Updated : October 11, 2018
Details
Key Milestones2 | |
|---|---|
| Call for patient input posted | October 04, 2018 |
| Patient group input closed | November 23, 2018 |
| Clarification: - No patient input submission received | |
| Submission received | November 02, 2018 |
| Submission accepted for review | November 16, 2018 |
| Review initiated | November 22, 2018 |
| Draft Canada's Drug Agency review report(s) sent to applicant | February 12, 2019 |
| Comments from applicant on draft Canada's Drug Agency review report(s) received | February 22, 2019 |
| Redaction requests from applicant on draft Canada's Drug Agency review report(s) received | March 05, 2019 |
| Clarification: - Extension requested by applicant - Request granted | |
| Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to applicant | March 29, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | April 10, 2019 |
| CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to applicant and drug plans | April 24, 2019 |
| Embargo period ended and validation of redacted Canada's Drug Agency review report(s) received | May 08, 2019 |
| CDEC Final Recommendation issued to applicant and drug plans | May 15, 2019 |
| CDEC Final Recommendation posted | May 17, 2019 |
| Final Canada's Drug Agency review report(s) posted | June 10, 2019 |
Last Updated : June 13, 2019
Details
Key Milestones2 |
|
|---|---|
| Call for patient input posted | October 03, 2018 |
| Patient group input closed | November 22, 2018 |
| Clarification:
- No patient input submission received |
|
| Submission received | November 01, 2018 |
| Submission accepted for review | November 08, 2018 |
| Review initiated | November 09, 2018 |
| Clarification:
- Submission temporarily suspended pending receipt of information - Submission was cancelled by Canada's Drug Agency on 31 May 2019 as the biosimilar review process has been discontinued |
|
Last Updated : May 17, 2019
Details
Key Milestones2 |
|
|---|---|
| Call for patient input posted | September 26, 2018 |
| Patient group input closed | November 15, 2018 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | November 28, 2018 |
| Patient group comments on input summary closed | December 05, 2018 |
| Clarification:
- No patient input summary feedback received |
|
| Submission received | November 02, 2018 |
| Submission accepted | November 16, 2018 |
| Review initiated | November 19, 2018 |
| Draft Canada's Drug Agency review report(s) sent to sponsor | February 20, 2019 |
| Comments from sponsor on draft Canada's Drug Agency review report(s) received | March 01, 2019 |
| Redaction requests from sponsor on draft Canada's Drug Agency review report(s) received | March 08, 2019 |
| Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to sponsor | March 29, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | April 10, 2019 |
| CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to sponsor and drug plans | April 25, 2019 |
| Embargo period ended and validation of redacted Canada's Drug Agency review report(s) received | June 07, 2019 |
| Clarification:
- Request for extension to embargo period received from the manufacturer - Embargo extension request granted - Reconsideration requested |
|
| Sponsor's request for reconsideration placed on CDEC agenda | September 18, 2019 |
| CDEC recommendation sent to sponsor and drug plans | September 25, 2019 |
| Embargo period ended | October 09, 2019 |
| CDEC Final Recommendation issued to sponsor and drug plans | October 17, 2019 |
| CDEC Final Recommendation posted | October 22, 2019 |
| Final Canada's Drug Agency review report(s) posted | November 19, 2019 |
Last Updated : June 18, 2020
Details
‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.
Last Updated : June 17, 2019
Details
Key Milestones2 | |
|---|---|
| Call for patient input posted | September 19, 2018 |
| Patient group input closed | November 08, 2018 |
Clarification: - Patient input submission received from Arthritis Consumer Experts, Canadian Psoriasis Network (CPN), Canadian Skin Patient Alliance (CSPA) and the Canadian Association of Psoriasis Patients (CAPP) | |
| Patient input summary sent for review to patient input groups | November 15, 2018 |
| Patient group comments on input summary closed | November 22, 2018 |
Clarification: - Patient input summary feedback received | |
| Submission received | October 22, 2018 |
| Submission accepted for review | November 05, 2018 |
| Review initiated | November 06, 2018 |
| Draft Canada's Drug Agency review report(s) sent to sponsor | January 25, 2019 |
| Comments from sponsor on draft Canada's Drug Agency review report(s) received | February 05, 2019 |
| Redaction requests from sponsor on draft Canada's Drug Agency review report(s) received | February 12, 2019 |
| Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to sponsor | March 08, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | March 20, 2019 |
Clarification: CDEC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements. | |
| CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to sponsor and drug plans | May 02, 2019 |
| Embargo period ended and validation of redacted Canada's Drug Agency review report(s) received | May 16, 2019 |
| CDEC Final Recommendation issued to sponsor and drug plans | May 24, 2019 |
| CDEC Final Recommendation posted | May 28, 2019 |
| Final Canada's Drug Agency review report(s) posted | June 24, 2019 |
Last Updated : October 29, 2019
Details
Key Milestones2 |
|
|---|---|
| Call for patient input posted | September 14, 2018 |
| Patient group input closed | November 05, 2018 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | December 14, 2018 |
| Patient group comments on input summary closed | December 21, 2018 |
| Submission received | November 16, 2018 |
| Submission accepted for review | November 30, 2018 |
| Review initiated | December 03, 2018 |
| Draft Canada's Drug Agency review report(s) sent to sponsor | February 22, 2019 |
| Comments from sponsor on draft Canada's Drug Agency review report(s) received | March 05, 2019 |
| Redaction requests from sponsor on draft Canada's Drug Agency review report(s) received | March 12, 2019 |
| Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to sponsor | March 29, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | April 10, 2019 |
| CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to sponsor and drug plans | April 23, 2019 |
| Embargo period ended and validation of redacted Canada's Drug Agency review report(s) received | May 07, 2019 |
| CDEC Final Recommendation issued to sponsor and drug plans | May 14, 2019 |
| CDEC Final Recommendation posted | May 16, 2019 |
| Final Canada's Drug Agency review report(s) posted | June 12, 2019 |
Last Updated : October 29, 2019
Details
Key Milestones2 |
|
|---|---|
| Call for patient input posted | September 14, 2018 |
| Patient group input closed | November 05, 2018 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | December 14, 2018 |
| Patient group comments on input summary closed | December 21, 2018 |
| Submission received | November 16, 2018 |
| Submission accepted for review | November 30, 2018 |
| Review initiated | December 03, 2018 |
| Draft Canada's Drug Agency review report(s) sent to applicant | February 22, 2019 |
| Comments from applicant on draft Canada's Drug Agency review report(s) received | March 05, 2019 |
| Redaction requests from applicant on draft Canada's Drug Agency review report(s) received | March 12, 2019 |
| Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to applicant | March 29, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | April 10, 2019 |
| CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to applicant and drug plans | April 23, 2019 |
| Embargo period ended and validation of redacted Canada's Drug Agency review report(s) received | May 07, 2019 |
| CDEC Final Recommendation issued to applicant and drug plans | May 14, 2019 |
| CDEC Final Recommendation posted | May 16, 2019 |
| Final Canada's Drug Agency review report(s) posted | June 14, 2019 |
Last Updated : June 14, 2019
Details
Updates for Patients and Communities
If you missed today’s webinar “Ensuring Patient Voices Are Heard: How Patients Can Contribute to the Canada's Drug Agency Symposium,” it will also be available in Events Archives.
Last Updated : September 13, 2018
Details
‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.
Last Updated : January 14, 2019