Canada's Drug Agency is pleased to announce the launch of the Canada's Drug Agency Pharmaceutical Reviews Update, a new consolidated publication that will be used to communicate updates to our drug review processes. This new update replaces the following individual communications: CDR Update, pCODR Update, Therapeutic Review Update, and Updates for Patient Groups.
‡ 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.
‡ 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.
‡ 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.
Key Milestones2 |
|
|---|---|
| Call for patient input posted | July 25, 2018 |
| Patient group input closed | September 14, 2018 |
| Clarification:
- No patient input submission received |
|
| Submission received | December 20, 2018 |
| Submission accepted for review | January 11, 2019 |
| Review initiated | January 14, 2019 |
| Draft Canada's Drug Agency review report(s) sent to applicant | March 28, 2019 |
| Comments from applicant on draft Canada's Drug Agency review report(s) received | April 08, 2019 |
| Redaction requests from applicant on draft Canada's Drug Agency review report(s) received | April 15, 2019 |
| Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to applicant | May 03, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | May 15, 2019 |
| CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to applicant and drug plans | May 29, 2019 |
| Embargo period ended and validation of redacted Canada's Drug Agency review report(s) received | June 12, 2019 |
| CDEC Final Recommendation issued to applicant and drug plans | June 19, 2019 |
| CDEC Final Recommendation posted | June 21, 2019 |
| Final Canada's Drug Agency review report(s) posted | July 16, 2019 |
Key Milestones2 |
|
|---|---|
| Call for patient input posted | April 04, 2019 |
| Clarification:
Canada's Drug Agency initially posted the call for patient from July 12, 2018 to August 31, 2018. The pending submission was subsequently delayed and Canada's Drug Agency re-posted the call for patient input when the revised filing date was received. |
|
| Patient group input closed | May 27, 2019 |
| Clarification:
- Patient input submission received from Migraine Canada Migraine Quebec |
|
| Patient input summary sent for review to patient input groups | June 03, 2019 |
| Patient group comments on input summary closed | June 10, 2019 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | May 02, 2019 |
| Submission accepted | May 16, 2019 |
| Review initiated | May 17, 2019 |
| Draft Canada's Drug Agency review report(s) sent to sponsor | August 01, 2019 |
| Comments from sponsor on draft Canada's Drug Agency review report(s) received | August 13, 2019 |
| Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to sponsor | October 03, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | October 16, 2019 |
| CDEC recommendation sent to sponsor and drug plans | October 30, 2019 |
| Embargo period ended | December 11, 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 | March 18, 2020 |
| CDEC recommendation sent to sponsor and drug plans | March 25, 2020 |
| Embargo period ended | May 13, 2020 |
| Clarification:
- Request for extension to embargo period received from the sponsor - Embargo extension request granted - Reconsideration requested - Sponsors request for reconsideration placed on the July 15, 2020 CDEC agenda |
|
| CDEC Final Recommendation & Canada's Drug Agency review report(s) issued to sponsor and drug plans | July 22, 2020 |
| CDEC Final Recommendation posted | July 24, 2020 |
| Redaction requests from sponsor on draft Canada's Drug Agency review report(s) received | August 06, 2020 |
| Redacted Canada's Drug Agency review report(s) sent to sponsor and drug plans | August 18, 2020 |
| Validation of redacted Canada's Drug Agency review report(s) received | August 25, 2020 |
| Final Canada's Drug Agency review report(s) posted | September 18, 2020 |
Key Milestones2 |
|
|---|---|
| Call for patient input posted | July 04, 2018 |
| Patient group input closed | August 23, 2018 |
| Clarification:
- Patient input submission received from the Canadian Skin Patient Alliance in collaboration with Wounds Canada |
|
| Patient input summary sent for review to patient input groups | August 31, 2018 |
| Patient group comments on input summary closed | September 10, 2018 |
| Submission received | August 02, 2018 |
| Submission accepted for review | August 17, 2018 |
| Review initiated | August 24, 2018 |
| Draft Canada's Drug Agency review report(s) sent to applicant | November 08, 2018 |
| Comments from applicant on draft Canada's Drug Agency review report(s) received | November 19, 2018 |
| Redaction requests from applicant on draft Canada's Drug Agency review report(s) received | November 26, 2018 |
| Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to applicant | January 04, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | January 16, 2019 |
| CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to applicant and drug plans | January 29, 2019 |
| Embargo period ended and validation of redacted Canada's Drug Agency review report(s) received | March 13, 2019 |
| Clarification:
- Request for extension to embargo period received from the manufacturer - Embargo extension request granted - Reconsideration requested |
|
| Applicant's request for reconsideration placed on CDEC agenda | May 15, 2019 |
| CDEC Final Recommendation issued to applicant and drug plans | May 23, 2019 |
| CDEC Final Recommendation posted | May 27, 2019 |
| Final Canada's Drug Agency review report(s) posted | June 17, 2019 |
Key Milestones2 |
|
|---|---|
| Call for patient input posted | June 22, 2018 |
| Patient group input closed | August 14, 2018 |
| Patient input summary sent for review to patient input groups | September 04, 2018 |
| Patient group comments on input summary closed | September 11, 2018 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | July 24, 2018 |
| Submission accepted for review | August 08, 2018 |
| Review initiated | August 09, 2018 |
| Clarification:
- Selected for participation in Canada's Drug Agency/INESSS Clinical Engagement Pilot |
|
| Draft Canada's Drug Agency review report(s) sent to applicant | October 15, 2018 |
| Comments from applicant on draft Canada's Drug Agency review report(s) received | October 29, 2018 |
| Redaction requests from applicant on draft Canada's Drug Agency review report(s) received | November 20, 2018 |
| Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to applicant | November 09, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | November 21, 2018 |
| CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to applicant and drug plans | December 05, 2018 |
| Embargo period ended and validation of redacted Canada's Drug Agency review report(s) received | December 19, 2018 |
| Clarification:
- Reconsideration requested - Clarification requested by CDR-participating drug plans |
|
| Applicant's request for reconsideration placed on CDEC agenda | February 20, 2019 |
| Drug plans' request for clarification placed on CDEC agenda | February 20, 2019 |
| Response to request for clarification and CDEC Final Recommendation sent to applicant and drug plans | February 27, 2019 |
| CDEC Final Recommendation posted | March 01, 2019 |
| Final Canada's Drug Agency review report(s) posted | April 05, 2019 |
‡ 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.
‡ 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.