Update on Procedures for the CADTH Common Drug Review (CDR) for Advance Notification of
Anticipated Submissions and Resubmissions
1. Revised Advance Notification Procedure for CDR
Effective immediately, CADTH has revised the advanced notification procedure for the CADTH Common
Drug Review (CDR) to reduce the mandatory advance notification requirement from 120 calendar days
to 30 business days for drugs undergoing review through one of the following expedited Health Canada
review pathways: 1) priority review; or 2) Notice of Compliance with Conditions (NOC/c) at the outset.
Table 1: Revised Procedure for Drugs Undergoing an Expedited Review by Health Canada
Health Canada
Review Type
 Priority review
 NOC/c at the
outset
All other Health
Canada review
types
Advance Notification Procedure
Manufacturers must provide a minimum of 30 business days of advance notice for all
pending CDR submissions for drugs undergoing review through one of the following
a
expedited Health Canada review pathways:
 Priority review
 NOC/c at the outset
For all pending CDR submissions for drugs not granted priority review or undergoing review
for an NOC/c at the outset by Health Canada, and for all resubmissions, manufacturers
must continue to provide mandatory notification of at least 120 calendar days, by email to
[email protected], prior to filing the submission or resubmission.
CDR = Common Drug Review; NOC/c = Notice of Compliance with conditions.
a
Must have been accepted for review by Health Canada on or before June 1, 2016.
2. Revised Date for Confirmation of Anticipated Filing Date
CADTH has received a number of requests from stakeholders to clarify how CDR defines one month in
the existing confirmation step in the advance notification procedure (i.e., confirm the anticipated date
of filing the complete submission or resubmission one month in advance). In addition, CADTH has
encountered some practical challenges within the CDR program due to the fact that the current one
month threshold coincides with the timeline for posting the call for patient input (i.e., 20 business days
in advance of the filing date). As a result of these challenges, the timing for the manufacturer
confirmation step is being revised to 30 business days. This revision introduces the following efficiencies:
 Provides clarity regarding the required timing of confirmation by setting a clear target in
business days
 Provides separation of the timing for confirming the date of filing and the timing for posting
patient group input.
Table 2: Revised Date for Confirmation of Anticipated Filing Date
Previous Confirmation Procedure
A manufacturer is required to advise CDR by email
([email protected]) of changes in the anticipated date
of filing a submission or resubmission as soon as
possible, and to similarly confirm the anticipated date
of filing the complete submission or resubmission one
month in advance.
Current Confirmation Procedure
A manufacturer is required to advise CDR by email
([email protected]) of changes in the anticipated date
of filing a submission or resubmission as soon as
possible, and to similarly confirm the anticipated date
of filing the complete submission or resubmission 30
business days in advance.
CDR = Common Drug Review
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3. Advance Notification Procedure for Drugs Undergoing an Expedited Review by Health Canada
Manufacturers must provide a minimum of 30 business days advance notification for CDR submissions
being filed for drugs that are undergoing review through one of the following expedited Health Canada
review pathways: priority review or NOC/c at the outset. This revised notification process applies to
submissions that are filed on either a pre-NOC or post-NOC basis. This procedural revision has been
made to facilitate timely submissions for products undergoing an expedited review by Health Canada;
therefore, in order to be eligible for this revised process, the drug must have been accepted for review
by Health Canada on or after June 1, 2016.
All manufacturers are still encouraged to provide CADTH with as much notification as possible to
facilitate resource planning, including clinical expert recruitment, and budgeting for the CDR program.
CADTH encourages manufacturers to consider the threshold of 30 business days as the minimum
amount of advance notification that is required to avoid a delay in processing the submission and not as
the target or optimal amount of notification. All manufacturers are requested to advise CADTH of
changes in the anticipated date of filing a submission as soon as possible. Manufacturers who provide
notification of greater than 30 business days in advance of the anticipated date of filing are required to
confirm the anticipated submission date 30 business days in advance (Table 2). Information regarding a
pending CDR submission or resubmission will be posted on the CADTH website at the time the call for
patient input is issued (i.e., 20 business days before the anticipated filing date, so that patient advocacy
groups have as much notice as possible about a pending review).
The advance notification forms have been updated to allow manufacturers to identify whether or not
the pending submission is for a drug that has received a priority review designation from Health Canada
or has been accepted for review for an NOC/c at the outset. The 30 business day notification period will
be counted from the date of receipt of the CADTH Pre-submission Information Requirements Form to the
targeted filing date for all anticipated submissions. If a manufacturer does not provide advance
notification at least 30 business days from the date of receipt of the CADTH Pre-submission Information
Requirements Form to the targeted submission date, this may result in a delay in the processing and
screening of the submission by CADTH.
Table 3: Summary of Advance Notification Process for Expedited Health Canada Reviews
a
Advance Notification Procedure
Days Prior to Anticipated Filing Date
CADTH preferred advance notification
Minimum advance notification
Confirmation of anticipated date:
 If > 30 days advance notification provided
 If 30 days advance notification provided
Call for patient input
≥ 120 calendar days
30 business days
30 business days
a
Only required if the date is revised
20 business days
CADTH strongly discourages manufacturers from revising the anticipated filing date after providing confirmation.
4. Advance Notification Procedure for All Other Submissions and Resubmissions
With the exception of pending submissions for drugs undergoing an expedited review by Health Canada
(i.e., priority review or NOC/c from the outset), manufacturers must provide a minimum 120 calendar
days of advance notification for anticipated submissions and resubmissions. The 120 calendar day
notification period will be counted from the date of receipt of the CADTH Pre-submission Information
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Requirements Form to the targeted filing date for all anticipated submissions and resubmissions. If the
120th day falls on a weekend or statutory holiday, the following business day will be applied.
If a manufacturer does not provide advance notification at least 120 calendar days from the date of
receipt of the CADTH Pre-submission Information Requirements Form to the targeted submission date,
this may result in a delay in the processing and screening of the submission or resubmission by CADTH.
This decision will be made by CADTH based on the availability of resources.
All manufacturers are requested to advise CADTH of changes in the anticipated date of filing a
submission or resubmission as soon as possible. Manufacturers are required to confirm the anticipated
date of filing the complete submission or resubmission 30 business days in advance (Table 3).
Information regarding a pending CDR submission or resubmission will be posted on the CADTH website
at the time the call for patient input is issued (i.e., 20 business days before the anticipated filing date, so
that patient advocacy groups have as much notice as possible about a pending review).
Table 4: Summary of Advance Notification Process for Non-Expedited Health Canada Reviews
a
Advance Notification Procedure
Days Prior to Anticipated Filing Date
Minimum advance notification
Confirmation of anticipated date
Call for patient input
120 calendar days
a
30 business days
20 business days
CADTH strongly discourages manufacturers from revising the anticipated filing date after providing confirmation.
5. Completing and Filing the CADTH Pre-submission Information Requirements Form
All manufacturers are required to use the following advance notification forms:
 CADTH Pre-submission Information Requirements Form for a submission
 CADTH Pre-submission Information Requirements Form for a resubmission
To fulfill the advance notification requirement, all manufacturers will be required to complete the
CADTH Pre-submission Information Requirements Form for each submission or resubmission and to
submit the form to the CDR program at [email protected].
CADTH recognizes that manufacturers may not be able to complete all sections of the CADTH Presubmission Information Requirements Form for submission and resubmission at the time of providing
advance notification; however, at minimum, CDR will require that a manufacturer complete the
following sections:
 Non-proprietary name of drug
 Indication
 Requested reimbursement criteria
 Date of Notice of Compliance (NOC or NOC/c), issued or anticipated
 Health Canada review type
 Anticipated date of filing this submission or resubmission with CADTH
 List of reimbursement and regulatory decision status in other countries/regions
 Rationale for resubmission (resubmission only)
The above mentioned information requirements must be completed and submitted to CADTH via the
CADTH Pre-submission Information Requirements Form. If any of the above mentioned information is
not provided, the CADTH Pre-submission Information Requirements Form will be deemed incomplete
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and may not be accepted. Other sections within the CADTH Pre-submission Information Requirements
Form for submissions and resubmissions must be completed and updated at the time of filing a
submission or resubmission.
This information may include the brand name (if available and not confidential until approved) and nonproprietary name of the drug, submission type, NOC status at the time of filing, a brief description of the
therapeutic area, requested reimbursement criteria, submission target date, stakeholder input deadline,
and the name of the manufacturer.
Should you have any questions about the advance notification process for CDR, please contact us at
[email protected].
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